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The Pains Which Are To Come

by Nina

Oak Tree in Late Summer Light by Brad Gibson

II.16. heyaim dukham anagatam

The pains which are yet to come can be and are to be avoided.
—Yoga Sutras, translation by B.K.S. Iyengar

Last night a friend was telling me what she loved about our blog was that it was positive and optimistic. We write about good things, she said, and have positive solutions. Well, we do believe that yoga has many answers for helping us age gracefully, and we regularly recommend various poses and practices for preventing and/or reducing many of the “pains” that accompany aging. But, I have to say, we are also realists, both about the “aging” and “yoga” parts of our mission. In the last five years, Brad and I have seen all four of parents die. All were in their eighties or nineties, and they died of diseases typical of the elderly (cancer, Alzheimer’s, stroke). Without going into details, I’ll say none of these deaths were particularly pretty, and certainly no amount of yoga poses or practices could have helped prevent the decline and pain that came at the end. In fact, with two of the deaths, from cancer and from kidney failure, we’re grateful for modern medicine’s painkillers.

As I’m sure many of you must know, experiencing the death of your own parents is sure to make you contemplate your own. We wonder for ourselves, if it is possible, how can we avoid the pains which are to come? For me, this is where yoga philosophy comes in. (Studying the scriptures is svadhyaya, one of niyamas that comprise the second branch of yoga, so this is as much a part of yoga as anything else we do and is obviously available to anyone, regardless of age or physical condition.)

Although I tend to turn to the Bhagavad Gita for wisdom about cultivating equanimity, I also find the Yoga Sutras an invaluable resource. To my mind, the Yoga Sutras is a brilliant work of psychology. Patanjali deconstructs how the mind works, identifying the roadblocks to cultivating equanimity, and then goes on to recommend solutions. I find this sutra particularly relevant for those of us concerned about aging:

11.3. The five afflictions (klesas) which disturb the equilibrium of consciousness are: ignorance or lack of wisdom, ego, pride of the ego or the sense of ‘I,’ attachment to pleasure, aversion to pain, fear of death and clinging to life. —Yoga Sutras, translation by Edwin Bryant

Aversion to pain, fear of death, and clinging to life, all of which seem to come along with aging, do indeed disturb our sense of equanimity. But the very fact that these feelings are identified as “afflictions” suggests to me that while there is always difficulty, including pain and death, we don’t necessarily have to experience it as suffering. It’s the aversion to pain that causes suffering, not the pain. And it’s the fear of death and clinging to life that causes suffering, not death—or dying—itself.

I actually find this explanation alone to be very helpful. For rather than just feeling that suffering is inevitable, knowing there is a difference between a difficult situation and my reaction to it helps me from getting so caught up in it (well, it’s a work in progress). So that’s a little “wisdom” to counteract the “ignorance” that is another one of the klesas. You can find a lot more wisdom in the Yoga Sutras, and I recommend reading this if you haven’t already. But what does Patanjali recommend for overcoming the klesas? After introducing the klesas and describing each one in detail, Patanjali simply says the following:

II.11. The states of mind produced by these klesas are eliminated by meditation. —Yoga Sutras, translation by Edwin Bryant

My friends will all tell you that I take very good care of myself. I practice yoga asana regularly, in way that supports my particular body and needs, I include stress management practices for my emotional well-being as well as my physical health, and I eat a healthy diet. But I believe that, in the end, cultivating equanimity through wisdom and practice will be the most important aspect of my healthy aging.

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Gene Therapy in Ophthalmology Update 7 2012 the Year for Gene Therapy

While I have previously written about the progress being made in the use of stem cells in ophthalmology (see Stem Cell Update 13) and described the 9-10 clinical trials currently underway or about to start (see Stem Cell Update 14), recent events point to 2012 becoming a breakthrough year for the use of gene therapy to overcome genetic defects that cause several ophthalmic diseases.

In the accompanying table, I list the fourteen clinical trials that I know about in the use of gene therapy in treating ophthalmic disease. Half of the trials are aimed at treating Leber’s Congenital Amaurosis (LCA), while three are for treating the wet form of AMD; one is underway for treating Choroideremia; one for Stargardt’s Disease; and two are aimed at different forms of retinitis pigmentosa (Autosomal Recessive RP and Usher Syndrome 1b).

In addition, I show at least twenty four clinical trials in either the pre-clinical (animal study) mode, or a couple in the IND-preparation mode. That is close to forty clinical trials using gene therapy to treat ophthalmic diseases.

The treatment of Leber’s using gene therapy has been ongoing for at least three years and, as I will show in the next update (Gene Therapy Update 8), those trials are going quite well, with many of the patients showing improved vision.

Finally, as another indicator that gene therapy will play an important role in ophthalmology in this year, Ocular Surgery News is about to begin a special section, OSN Retina, to be part of it’s coverage of the ophthalmic scene. The January 25 issue of Ocular Surgery News will include OSN Retina - a leading destination that will provide retina specialists with more relevant information specific to their field.. The premiere issue will include a feature on how  “Retinal gene therapy may pave the way for attempts to reverse genetic disease: Advancements in retinal gene therapy have prompted a collaborative effort to attain FDA approval.”

For those of you who wish a better understanding of how gene therapy works, and until I write the Primer on the Use of Gene Therapy in Ophthalmology, which I have threatened to write for the past year and a half, you can gain an understanding by reading my first article about gene therapy, written back in November 2010, The Use of Gene Therapy in Treating Retinitis Pigmentosa and Dry AMD by Retrosense.

Here then is my latest version of Gene Therapy in Ophthalmology by Application:

A pdf file of the table is available by email request.

Spirometers And How They Work

By Debra Cooley

Individuals who are suffering from respiratory conditions often benefit greatly from a medical diagnostic machine referred to as a spirometer. The latter is designed to take a highly detailed reading of a patient's breathing function. This is particularly advantageous to those suffering from disorders of the lung, including emphysema or asthma. Spirometers measure how much air volume one is able to inhale, as well as the strength of his or her respirations.

In the use since the dawn of the 19th century, devices of this kind are essentially always used to assist doctors to make accurate diagnoses of lung problems. The science used to create such devices has been perfected resulting in the now commonly used digitized models. Although not all devices provide digital readings, most contemporary humans have this feature. Practitioners can choose from various models when performing the aforementioned tests.

Isolating a patient's lung capacity and respiratory strength plays an important role in the accuracy of the prognosis. This is why devices of this type are used in virtually all medical facilities, including acute care hospitals or long-term care establishments. They are also frequently utilized by doctors who want to discover if those who have recently been operated on and are awakening from anesthesia are returning to normal lung function.

Evaluating the results of certain medications or medical treatments is another reason doctors may use the device mentioned above. Additionally, spirometers can tell practitioners if a person's condition is progressing or getting better. If disrupted or decreased airflow is discovered, a spirometer can help the doctor to determine the severity of the obstruction. For this reason, equipment of this kind is used by essentially all pulmonologists and lung doctors.

Devices of this kind are made from temporary tubing that is affixed to the measuring device and mouthpiece. The individual is usually instructed to close his or her mouth tightly around the latter and breathe in and out regularly. The patterns of his or her respirations are then recorded on a digital graph.

The results printed on the graph are forwarded to the patient's physician or pulmonologist. The latter can then evaluate the readings and use them to design an appropriate care plan for each individual being treated. The device can also help physicians to determine whether or not drug adjustments may be indicated.

In addition, those afflicted with rare lung disorders, including mesothelioma, can benefit from testing completed with spirometers. This is because such devices can do certain things other diagnostic tools cannot, such as monitoring both the lower and upper pulmonary regions. This specific benefit allows the pulmonologist or physician to zero in on specific problems with precise accuracy.

When spirometers are used for the aforementioned testing, the length of time it takes to complete the test will vary from a few minutes to an hour. This depends on the data for which the doctor is looking. In most cases, the test does not exceed one hour. Because of the numerous advantages they provide, this kind of device will likely remain a popular diagnostic tool with many professionals in the medical field, such as doctors or pulmonologists.

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How To Locate A Good Day Spa

By Leanne Goff

You want to get the services extended in a day spa in pittsburgh pa. You're aiming to refer to the right place this time, so you can maximize the whole experience. So, you need to have a good idea of the things that you must look into before you decide on referring to a specific one.

Consider what services you require from these providers as well. It is helpful that you will already set your expectations ahead of time. It will be a lot easier for you to ascertain who to refer to and who to get assistance from. You can use your expectations and your needs as very good basis towards ensuring that you will only refer towards the right people this time.

If you have never referred to the assistance extended by these providers before and you have no idea who to go to and who you ought to get assistance from, the people you know might be able to help. These people might have referred to the services of the same providers before. They can easily give you an idea of the things that you are supposed to do to find the right establishments.

Give these providers a call to get a better idea of what it is that they may be capable of offering to you. Relying on the information of the people around you alone may not be very reliable. The services offered by these professionals significantly change every time. So, what you can do instead is make sure that you call them up first and get the details straight from them instead.

Consider the rates that you are likely going to have to pay when enlisting the services of these providers too. Consider how much you have set aside as your budget for this particular need. It is always very helpful that you will know the existing rates around as well.

If you wan to ensure that you will take advantage of the right establishments with the right offers. It helps to shop around. Make sure that you get to make the necessary comparisons as well. This should at least give you a good notion of what the professionals can extend to you before you will decide on what it is that they may be able to offer to you.

You must find the place that is considered to be very much accessible as well. It is very reassuring that you will go for these establishments that happen to be quite near where you reside. You would not want to have to spend a long time in your car when getting there. You might end up getting stressed out after you have just enjoyed your time within.

You might consider setting an appointment to the day spa in pittsburgh pa too. You have to consider the fact that these places may be very popular with the patrons to be sure that somebody should be there to attend to your needs and assist you. It might help if you will get the necessary reservations done ahead of time. So, check how you can get such arrangements carried out.

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Roles Played By Personal Fitness Santa Cruz CA Professional

By Douglas Roberts

Individuals who are trained on how to handle fitness centers play very important roles. They can be involved in ensuring that the people who are in attendance attain the best. Personal fitness Santa Cruz CA is mainly done so as people can get new shapes. Those people who have to attain large sizes of their bodies need to attend to these centers so as they can lose the large sizes.

It is possible for one to perform some tasks the way they are not supposed to be done. This calls for one to look for professionals who can aid in ensuring that you get the appropriate looks. It is necessary for one to come up with better ways in which they can get all the required information to guide one on handling fitness materials. Experts can be consulted as well to aid in getting the correct results.

The trainer should dedicate most of the time at your service. This is important as they are likely to deliver the best. When you are in need of exercising, the person should always be close to you. This helps in ensuring that you get the most appropriate training and thus end up having a nice look. These trainers are capable of handling different people at a time.

In case you ignore the work of a trainer, one can end up performing one task. This is very disadvantageous as one may fail to achieve any improvement after continuously engaging in such activities. You should look for a helper to aid you in attaining the suitable results. The individual can guide you on how to handle the items in the fitness center easily without any side effects.

The fee imposed by these people should also be sufficient. Therefore, when you are in search of an expert in such an area, he or she can be having a higher level of training. This determines the amount of money one get charged. Those who are highly trained can end up offering their services at higher prices. This can lead individuals to ignore their services and thus end up failing to acquire the correct service.

The experience of the trainer matters a lot. The person must possess enough training and experience so as they can offer good services. He or she should have enough experience in this field so as they can deliver the most appropriate services to the people. Such a person is likely to deliver the best service to the people. A well trained and experienced person can lead you in gaining a better look.

When you are going to the gym or any fitness center, you should have a definite reason behind it. This is essential because one is likely to get the intended purpose of joining the center. This helps in ensuring that you get better results out of the exercises that you carry out. This aids in attaining good results as well as developing a good stable size of your body.

A fitness center is essential as people can use the facilities in there to change their body shapes. They can use these places to improve their health as well as develop new body weights. You must be consistent in the activity so as you achieve better results.

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Melt Those Pounds Away With Weight Loss Hypnosis West Springfield

By Mattie Knight

Obesity is a health concern that many people face in modern society. With all the fast food and sugar coated snacks, is it any wonder that the population has put on a few extra pounds. Pounds that later they can't seem to lose no matter how much they diet and exercise. The popular fad diets are unnatural ways of eating that only lead to frustration, once you end the diet the pounds seem to come back faster. There is an alternative that is natural, safe and effective and does not require any invasive surgeries or liposuction. Hypnotherapy is quickly becoming an option for people who want to shed those pounds and what better way to melt those pounds away than with weight loss hypnosis West Springfield MA.

There are many types of diet plans and procedures on the market these days and while some may help you to lose weight quickly, many of these methods do not last and you end up gaining what you may have lost and even more. Hypnotherapy is a type of mind altering and behavior modification program that is safe, and natural. It changes the negative self talk you may have into more positive phrases that makes you feel like you can accomplish your goal no matter what.

The goal of this type of therapy is to change your behavior patterns to those of a healthier lifestyle such as with dieting and exercise on a regular basis and choosing healthy foods to eat. It reduces the temptation to snack in between meals and if you have a choice you will choose something healthy and non fattening. It is like getting a new brain with a new mindset on weight loss.

The mind holds the key to much of our behavior and habits. Our subconscious minds can hold all kinds of limiting beliefs and hypnotherapy can reverse that kind of thinking so that you are more successful in your attempts to shed pounds. If you can change your thoughts you can change your life.

The effects of hypnotherapy are permanent and lasting since you have basically changed the negative self talk in your mind. You will have new thoughts about losing the pounds and will not become discouraged. It is a simple solution for obesity that is gaining more and more attention each day.

Your goals are achievable but will take time. Do not expect to become thin overnight. You will be counseled on keeping a realistic goal and state of mind all while steadily working toward what you desire. The quick loss methods touted by supplement companies are unrealistic which has given dieters the impression that losing pounds quickly is the key and that simply is not true.

If you are thinking about doing something drastic to lose those pounds such as with surgery or fasting, think again, because there is a better, safer, and more natural approach to the problem. Hypnotherapy is not an invasive procedure nor is it something that will cause any negative side effects. It is simple, comfortable and relaxing and the only thing you will notice is your thoughts have changed for the better.

Weight management is something that we need to work on daily if we want to keep a slim and trim figure. What hypnotherapy does is makes sure that you develop safe and healthy habits that can last a lifetime and healthy thoughts about your body image and self esteem. This is worth more to you than the latest fad diet could ever be.

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Essentials Of Taking Part In Physical Therapy Pennsylvania

By Paul Clark

A number of health complications result from various disorders, accidents and illnesses. They may be severe to the point that normal body functions are difficult to carry out. After a successful operation, patients are required to take part in physical therapy Pennsylvania so as to speed up the recovery process.

Physical therapy is basically a dynamic profession with an established theoretical and scientific base. Therapists deal with restoring, maintaining and promoting optimal physical function. In addition to that, they prevent progression of impairments and disabilities which result from disease, injuries and disorders. In order to do their work properly they usually take the history of the patient, and then conduct a system review. Therefore, after a surgery, therapy is mandatory for a number of reasons.

Immediately after undergoing a surgery, the affected part tends to swell. This is caused by the accumulation of fluids. Such fluids may continue to collect in the related site when the individual fails to engage in exercises. By exercising, circulation of blood to all part of the body will definitely enable the fluids to be gotten rid of. In the long run, healing process is escalated.

An operation performed on lower body parts tends to hinder mobility. There is a huge interference with parts such as hips and knees, which are responsible for movement. When a treatment plan is formulated, mobility will gradually be restored. The only thing that is important is achievement of the objectives set. As time goes by, more rigorous exercise such as running will be engaged in.

Seeking the services of such professionals also helps the patient in taking charge of his or her own treatment exercise. Such patients are known to have good experiences with their therapists when compared to others with no professional support. In addition to that, they are given the opportunity to come up with weigh in on decisions made. Physical therapy has proven to be a proactive way of staying healthy.

During the sessions, the therapists will most likely to perform limb manipulation. The limb near the site of the surgery will be manipulated so as to improve the range of motion. The other activity likely to be performed involves balance and coordination training. This will assist patient in regaining independence. Similarly, massage will help in reducing inflammation of the affected part and get rid of the pain.

Physical therapy sessions are flexible to the point that they are able to take place in any setting. It is up to the client to select a convenient destination for the same. This can be in a nursing home, school or even the hospital itself. When given the freedom to dictate on these terms, the patient tends to cooperate fully.

Physical therapy should only be provided by qualified professionals who are aware of what they are doing. In Pennsylvania, the local authority states that they all have to be licensed so as to avoid putting the life of the patient in danger. Therefore, in the event that an individual finds themselves in a situation which needs the services of these professionals, they should definitely go for it.

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Things To Know About Sciatica Pain Treatment

By Iva Cannon

Physical therapy exercises with a combination of stretching, strengthening and aerobic conditioning are a primary component of any sciatica treatment plan. When a patient engages in a regular program of gentle exercise, he or she can recover more easily and quickly from sciatica pain and are less likely to have future series of pain.

In most instances, a progressive and controlled exercise underlies a certain cause of sciatic pains that will also be an integral part of the recommended treatment plan. A certain sciatica pain treatment Conroe will serve two different purposes. It is helpful in reducing the pain the bear terms and can provide well conditioning to prevent recurrences of the pains.

A physiatrist, chiropractor, physical therapist, certified athletic trainer and other spinal specialists who treats the leg ache and other symptoms will basically prescribe specific exercises or treatments and teach the patient how to do them. While it seems contrary to intuition, exercise is often better for relieving sciatic pains than bed rest.

Patients may rest for a day or two after their ache flares up but after that period, inactively will often make the condition worse. Actually, without proper exercise and movement, the back muscles and spinal structures become less able to support the back. The weakening and deconditioning can lead to strain and back injury which causes additional pains. Furthermore, active exercise is also crucial for the health of the spinal discs.

Caring for this condition should be considered well as part of the everyday routine for anyone. In addition to these routines, anyone with sciatica must also reduce the stress level on their lower back and keep on maintaining good posture. This way, your lower back will be supported properly while sitting and standing for a long span of time.

Before starting any treatment program, patients are recommended to see a health professional in Conroe, TX to get the right diagnosis for their condition and to cure more serious problems. The proper exercises will depend on the condition that cause the sciatica condition, so every patient must not try to self treat their condition before seeing a professional.

Typically, it is reasonable to consider surgery for sciatica in situations like sever leg ache that has persisted for 4 to 6 weeks or more. If the relief that is not achieved after a concerted effort on non surgical treatment such as a combination of oral steroids, manual manipulation, anti inflammatory medication, physical therapy or injections. The condition is limiting the ability of a patient to participate in daily activities.

If you experience progressive weakness of your legs and sudden loss of bladder control, then an urgent operation is necessary. Depending on the causes and its duration, one or two surgical operations can be considered such as an open decompression and a small open operation.

In some cases, surgical operation is a personal decision of a patient. So, performing the procedure will depend on you. If you prefer to undergo this operation, then you will be evaluated first. If not, you will be given with non surgical procedures such as light exercise based on your condition. This is because they will also consider the pain you have suffered as well as your overall health.

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What To Know About Best Multi Strain Probiotic Supplements

By Enid Hinton

Health can lead to happiness. If a person feels better they are more prone to carry out the things that make them feel happy. There are so many things that can be done to improve wellness and health, even as the body ages. Probiotics are know for their powerful benefits on well-being, particularly on gut health. There are numerous products available today, but some may be interested in finding the best multi strain probiotic supplements.

Probiotics are essentially live microorganisms, often bacteria. They are similar to that which is naturally found in the human body and designed to provide the gut with all that it needs to properly function. Also called good or friendly bacteria, the organisms are essential to creating balance in gut flora and optimal health. Supplements are accessible through many retailers.

No single supplement is the best for everyone. Like many things, people should test different ones out to see what works well for them. There are still many things worth considering when choosing between the many available. Reviews and ratings can be of aid when it comes to identifying the products or manufacturers that are well-liked among the majority.

Good bacteria should take up around 90 percent of the microbes that live in the gut. Unfortunately this is not a reality for a lot of people because medications, illnesses, stress and diet can alter the ratio of good to bad bacteria. This may manifest in many ways, including weakened immunity, eczema, gastrointestinal distress, constipation, diarrhea and inflammation. However, a good dose of probiotics can easily return harmony to the gut and make a person feel better.

Fermented foods are known for their high levels of probiotics. These are particularly healthy and include kombucha, kimchi, kefir, miso and sauerkraut. Although beneficial, these foods may not have as much to offer as a probiotic supplement. It may take time to find the right supplement for your needs.

There are many products available, each one has its own set of ingredients and potency. A first step should be looking over the labels. This is where people will find key information about number of organisms, supplement form, viability, certification by an independent third party, storage details, and the species, genus and strain of the microorganisms in the product.

Probiotics that have living microbes are recommended. People are not encouraged to purchase those that suggest the microbes were alive at the time the good was manufactured, as they are probably no longer living. The kind of bacterial included is also important because each strain has its own set of benefits. Keep in mind the number of organisms and how often the probiotics should be taken. It is suggested to choose a product with five billion colony forming units, CFU, as a minimum and seven strains. Quality supplements are often more costly.

Supplements can be powerful, but people must also consider what they consume and how that impacts the health of the gut. Consuming fiber and things that feed good bacteria is important. Be observant of how these supplements make you feel and if necessary, try out a different type if negative or no results present themselves.

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Find a review of the benefits of taking probiotic supplements and more information about the best multi strain probiotic supplements at http://novaprobiotics.com now.

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Choosing The Right Crossfit Roseburg Gym

By Marci Glover

People that are considering their needs for working toward a healthier life are offered an incredible number of programs and facilities to utilize. Many people are unclear about what options are the most suited for their needs when focused on the chance to actually make sure they are able to maximize their results. When selecting the right Crossfit Roseburg gym people are offered the chance to make sure their goals will be reached in a viable and comprehensive manner.

Crossfit has become one of the most popular and effective forms of fitness for consumers that are interested in athleticism and weight loss. The combination of cardiovascular and resistance training techniques offers people the opportunity to make sure their endeavors are as efficiently completed as possible while often being reliant on joining specific gyms. Joining decisions that are made from all available gyms are usually a challenge to complete.

Residents of Roseburg, OR that might be focused on this type of facility have a significant number of facilities to consider. Most consumers are not clear about all that should be considered when attempting to be confident their needs will be proactively met. The right decision is made when multiple ideas are fully considered.

People often initiate their choices by reading review posts that have been created by current and former members. Reviews are offered from people that are specifically aware of what the facility has to offer which can easily be utilized in determining what is actually offered to people that are interested in a membership. The choices people make should be from the highest rated facilities to help avoid major complications.

Potential members are also urged to consider the facilities that might be able to provide the most convenience for daily exercise routines. The daily life of most consumers is now understood to be difficult to manage and remain efficient with which prompts the need to make sure that any facility considered is efficiently accessed. Extensive operating hours and easily accessed facilities are the most effective to consider.

Membership requirements are also pertinent to concentrate on when making this difficult choice. Many facilities that consumers be of a specific age and fitness level prior to participating in programs that they offer. These requirements are clearly made available in most cases to help people make more viable choices.

Facilities should also be compared based on the kinds of instructors that are offered to consumers in need. Receiving training sessions from professionals is a major proponent of being able to participate in this highly specific fitness routine. Most gyms advertise their trainers and offer background information for people to actually make sure they are able to make a wise choice.

Consumers are also worried about membership fees when trying to make this particular choice. Fees that are required for membership are known to be stressful to contend with financially which is what prompts the need to seek out the lowest possible prices. Facilities that are the most affordable and offer the best access to consumers are usually able to provide a great value.

About the Author:

When you are looking for information about crossfit Roseburg locals should pay a visit to the web pages online here today. You can see details at http://www.ironfitroseburg.com now.

Delayed Rapid eye movements in glaucoma patients

Rapid eye movements are significantly delayed in patients with glaucoma.

The findings may shed light on why glaucoma patients are at an increased risk of falls and car accidents.

The researchers used head-mounted devices to measure saccadic (rapid) eye movements of individuals with and without glaucoma. They found that people with early, moderate or advanced glaucoma had significantly delayed rapid eye movements compared with individuals without the condition.

Lead study author and ophthalmologist, Neeru Gupta, said: “Now that we know that eye movement reaction times are delayed in people with glaucoma there is an opportunity to understand the effects of glaucoma on daily activities of living that most of us take for granted, such as walking up and down stairs, driving, navigating and reading.

“Further studies are needed to determine pathological processes implicated in delayed initiation of saccades, and to assess whether alterations of saccades affects daily activities in glaucoma patients.”

The Use of Gene Therapy in Treating Retinitis Pigmentosa and Dry AMD

A short while ago, I received a message from someone I did not know, who said that he enjoyed the writeups on my online Journal and was wondering if I might be interested in writing about the use of gene therapy as an approach to vision restoration. Since I knew absolutely nothing about gene therapy, the writer got my attention.

After several discussions with Sean Ainsworth, the founder of RetroSense, and much online research, I think I have learned a little about what gene therapy is about, and its application in ophthalmology, especially in the possible restoration of vision in those who suffer from retinitis pigmentosa (RP). Thanks to Sean for whetting my appetite -- here is what I have learned.

Introduction

In an article in Review of Ophthalmology in August 2009, Mark Abelson et al, wrote, “Instead of waiting for a disorder to occur and then treating it with a drug, imagine if we could prevent it from ever happening in the first place. This is the promise of gene therapy, and it's a new frontier for ophthalmic therapies that will be increasingly relevant in the decades to come. As appealing as prevention is, however, gene therapy's efficacy can be very difficult and costly to demonstrate, as  it requires large numbers of patients enrolled in long-term studies. Nevertheless, great strides are being made in the development of gene therapy treatment methods, including vector choice, targeting, selectivity and stability.”

Well, I don’t know about the use of gene therapy for prevention of a disease – I guess that would come when everyone has their genome mapped, and can identify which genes need to be fixed  or replaced. But, in the meantime, the idea of using gene therapy to give back sight to those who have lost it sounds like an idea whose’ time has come – or will come in the near future. And, as for gene therapy’s efficacy being difficult and costly to demonstrate, the facts haven’t borne this out in ocular studies.

A Phase I/II clinical trial in Leber Congenital Amaurosis (LCA) (more on this later) was done using gene therapy with 12 patients and the researchers saw signs of efficacy in as little as two weeks. Upon completion of their first trial, they headed straight into a Phase III clinical trial with 12 patients.

In this comprehensive overview of the use of gene therapy in the treatment of retinitis pigmentosa and dry AMD, I would like to introduce you to RetroSense Therapeutics and the work they have underway to develop a gene therapy treatment to restore vision in those who have lost it due to RP or dry AMD.


The Company: RetroSense Therapeutics

RetroSense Therapeutics was founded in 2009 by a team of seasoned veterans, to develop a novel gene therapy approach to vision restoration. The company is located in Ann Arbor, Michigan, a short drive from Wayne State University, where the approach was pioneered. RetroSense has secured exclusive, worldwide rights to relevant intellectual property from Wayne State University and Salus University.

The company was formed as a result of a commercialization assessment Sean Ainsworth was performing for Wayne State University. Ainsworth found that not only was this game-changing technology, but there was also high unmet need in the marketplace. And, while gene therapy, as a field, has seen some difficult times, tremendous advances were being made, particularly in ocular applications. According to Ainsworth, the intellectual property is also solid, as the primary inventor, Dr. Zhuo-Hua Pan was first to invent using channelrhodopsin-2 in vision restoration.

Ainsworth secured the rights to the intellectual property from Wayne State University and quickly found there was tremendous interest from leaders in the ophthalmology and biotechnology communities. He was able to bring together an impressive management team and advisory committee in short order.

RetroSense's management team has commercial and scientific experience across all phases of drug development, as well as startup success. The company operates virtually in order to secure top industry talent for its diverse, specialized needs in an efficient and effective manner.

The Management Team:

Sean Ainsworth, CEO

The management team is led by Sean Ainsworth who has fifteen years of experience in pharmaceuticals and biotechnology. His experience includes research at Medical Biology Institute (now Avanir Pharmaceuticals developers of Abreva, the leading cold sore medication) in San Diego, intellectual property at Koyama and Associates in Tokyo, and international corporate development consulting at The Mattson Jack Group in St. Louis, MO.

In 2004  Ainsworth launched Ainsworth BioConsulting to provide licensing, strategic planning, and business planning services to the life science and entrepreneurial community. Ainsworth has also had deep involvement in the launch of two previous startup companies, Compendia Bioscience, Inc. and GeneVivo, LLC where he assisted in licensing technologies, securing capital and first customers. Compendia BioScience is a profitable and growing company.

Ainsworth holds a BS in Microbiology from University of California, San Diego and an MBA in strategy and finance from Washington University in St. Louis.

Thomas Marten, COO

Thomas Marten has over twenty years of experience in pharmaceutical and biotechnology commercial operations with functional responsibilities including strategic planning, brand marketing, U.S. and global market research, business analysis, sales administration, and field sales.  Marten has had leadership roles with both large pharma and specialty biopharma companies including Glaxo Inc., Glaxo Wellcome, Bayer Biological Products, and Talecris Biotherapeutics.  Marten has significant experience in new product planning, brand strategy development, pricing and reimbursement strategy development, licensing related commercial due diligence, marketing, market research and sales force planning. Marten also has significant experience launching biologics into niche therapeutic areas and has worked with rare diseases including primary immunodeficiencies, hemophilia, and alpha-1 antitripsin deficiency.

In 2007  Marten founded Pharmacision LLC, a management consulting firm working with both large and small pharmaceutical companies to support strategic planning, drug development, and medical communications efforts. While at Pharmacision, Marten was instrumental in developing business plans, evaluating new product strategic opportunities, and coordinating with CROs and medical communications agencies to develop operational plans for numerous early stage pharma clients.

Marten has a BS in Medicinal Chemistry from the State University of NY at Buffalo and an MBA in Finance from the William E. Simon School of Business at the University of Rochester.

Edward "Ted" McGuire, PhD, Head of Pre-Clinical Development

Dr. McGuire has over 35 years of experience in pharmaceutical research and development, playing instrumental roles in the submission of numerous INDs, NDAs, and MAAs, including those for Lopidr, Accuprilr, Neurontinr, Lipitorr, and Rezulinr. Dr. McGuire's most recent positions include, Senior Director, Toxicological Sciences and Development at Parke-Davis, and Senior Scientific Advisor, Drug Safety Evaluation at Pfizer. During Dr. McGuire's tenure within pharma companies, he has supervised discovery and development teams - including gene therapy programs - coordinated and developed global toxicology plans, designed, conducted, and interpreted preclinical safety studies and study results, and led the resolution of issues impacting drug development.

Dr. McGuire received BSc and MSc degrees from the University of Windsor, Canada, and a PhD from The University of Michigan. He received a Distinguished Dissertation Award for his PhD thesis addressing hepatic effects of marketed lipid-regulating agents. He has published extensively and presented at numerous scientific meetings.

The Advisory Committee:

George A. Williams, MD, Scientific Advisor

George Lasezkay, PharmD, JD, Business Advisor

Dale Pfost, PhD, Business Advisor


The Diseases to Be Treated:

Retinitis Pigmentosa

Retinitis pigmentosa (RP) is a group of inherited genetic retinal degenerative disorders characterized by progressive peripheral vision loss and night vision difficulties followed by eventual central vision loss and blindness in many cases. RP is typically diagnosed in adolescents and young adults. The rate of progression and degree of visual loss varies from person to person.

Approximately 100,000 people living in the U.S. and between 0.03% and 0.04% of the global population suffer from RP. An estimated 25,000 people in the U.S. with RP have progressed to a more advanced form of the disease and are legally blind with 20/200 or worse vision. Currently, there are no FDA approved therapies for the prevention or treatment of RP. Future treatments may involve retinal implants, gene therapy, stem cell therapy, and/or drug therapies.

RetroSense will pursue RP as a lead indication for its RST-001 photosensitivity gene and seek orphan drug status.

Dry Age Related Macular Degeneration

Dry AMD occurs when the light-sensitive cells in the macula break down, gradually blurring central vision. The macula is located in the center of the retina, the light-sensitive tissue at the back of the eye. Over time, as more photoreceptors in the macula atrophy and die, central vision is lost.

Dry AMD is the most common type of macular degeneration and affects 90% of the people with AMD.

Advanced late-stage dry AMD, or geographic atrophy, is characterized by progressive loss of photoreceptors causing profound vision loss and in some cases, blindness. Nearly 1 million people in the U.S. suffer from advanced dry AMD. Of them, an estimated 200,000 people with advanced dry-AMD are legally blind and suffer from 20/200 vision or worse.

Currently there are no FDA approved therapies for the prevention or treatment of dry AMD. Future therapies may include stem cell therapy, gene therapy, drug therapy – including sustained-release drugs, and retinal regeneration using lasers or combined with stem cell therapy.

RetroSense will pursue Advanced Dry-AMD as a second indication for RST-001.


The Therapeutic Approach: Gene Therapy to Restore Vision in Retinitis Pigmentosa and Dry AMD

RetroSense Therapeutics is pioneering an innovative gene therapy approach to restore vision in people with retinal degenerative conditions where the loss of photoreceptors has led to blindness. Photoreceptors (rods and cones) are light sensitive cells in the eye that convert light signals to nerve impulses which are sent to the brain where they are interpreted and create the vision we sense. As photoreceptors die in retinal degenerative conditions such as retinitis pigmentosa (RP) and dry AMD, visual acuity and the ability to see in dimly lit rooms is diminished. Progressive loss of photoreceptors leads to blindness.

RetroSense is employing a gene therapy approach to deliver a new photosensitivity gene to retinal cells to restore the ability of eyes to sense light. As RP is caused by over 100 different gene defects, addressing each individually is not feasible with current technologies. RetroSense's approach is designed to "install" new photosensors, restoring vision irrespective of which gene defect is responsible for vision loss. What this means is, their approach promises application across a broad spectrum of RP patients.


RST-001

RetroSense's lead candidate, RST-001 employs a photosensitivity gene, channelrhodopsin-2 (Chop2), to create new photosensors in retinal cells and restore vision in retinal degenerative conditions such as RP and advanced dry-AMD.

Channelrhodopsin-2 is supported by a strong body of published literature on its efficacy and safety in animal models.(1) Numerous studies have demonstrated the ability of channelrhodopsin-2 to restore light perception and vision in animals with naturally occurring or induced blindness due to loss of photoreceptors. In primate studies, the administration of channelrhodopsin-2 was well tolerated. This approach to vision restoration was pioneered by Dr. Zhuo-Hua Pan at Wayne State University and Dr. Alex Dizhoor at Salus University.(2)

RetroSense is currently at the pre-clinical stage of development and working toward human clinical trials. RST-001 will be developed initially for retinitis pigmentosa, with advanced dry-AMD as a follow-on indication. The company currently anticipates filing an IND for RST-001 for RP by the end of Q3 2012 and commencing human clinical trials in Q4 2012.


How Gene Therapy Works

Gene therapy is the addition of new genes to a patient’s cells to restore or impart new function in order to overcome a disease – usually of genetic origin. Researchers typically deliver new genes to cells in modified virus vectors, as viruses have evolved to deliver genetic materials to cells.

(There is a second method of gene therapy – gene interference or silencing. In this technique, interfering or silencing of  a defective protein of a pair can be done using RNA interference. Since this technique is not used in treating either RP or AMD (or Leber’s), it is not discussed in this article.)

Gene therapy seems to be emerging as a viable means of treating diseases, after two decades of experimentation and trials, some of which was hallmarked by catastrophic results.

As Mark Abelson succinctly pointed out in his article, noted in the introduction, “Many fears surround gene therapy, stemming from concerns about inadvertently activating an autoimmune response, transfecting the wrong cells, activating oncogenes, or stimulating viral disease or tumor growth. While the blood-retina barrier provides some protection against such mishaps and decreases the likelihood of transfected cells spreading systemically, there are no guarantees.”

With regard to ocular gene therapy, Abelson also noted, “When other areas of the body receive gene therapy, rejection of viral capsids carrying the payload is a concern. The eye however, experiences reduced chances of vector rejection, just as foreign tissue in the eye experiences extended, if not indefinite, survival where it would be rapidly rejected in other parts of the body.”

“The eye is also relatively easy to monitor, both for potential side effects and for treatment benefit, with methods such as electroretinography, visual acuity, optical coherence tomography, and perimetry. Ophthalmoscopy and fundus photography also provide an easy way to directly visualize and document therapeutic effects.”

In the retina, photoreceptor cells convert light signals to electrical signals that are then relayed through second- and third-order retinal neurons to higher visual centers in the brain. The severe loss of photoreceptor cells caused by congenital retinal degenerative diseases, such as retinitis pigmentosa (RP), often results in complete blindness. RetroSense is exploring the possibility of genetically converting the surviving inner retinal neurons into directly photosensitive cells – thus imparting light sensitivity to retinas that lack active photoreceptors.

In the RetroSense approach, the company uses a virus, that has been stripped of its ability to replicate, as the delivery mechanism for the gene of interest, in this case, channelrhodopsin-2 (or Chop2) into the target cell – in the case of RP, being the ganglion cells and bipolar cells, as shown in the accompanying figure of the detailed makeup of the retina.

(This illustration taken from the RetroSense website and used with permission of Webvision)

The target cell's machinery reads the gene and creates the encoded Chop2 protein, which provides light sensitivity to these inner retinal cells, replacing the photosensitivity previously provided by the rods and cones that have become degenerated because of the disease.

In ocular gene therapy, the virus containing the gene of interest is injected into the eye, either subretinally, or intravitreally. Some distinct advantages of gene therapies in the eye are 1) the eye is an enclosed space, so the virus/gene is not distributed widely throughout the body, 2) smaller doses can be administered, 3) while the eye is not completely immune privileged, the immune response within the eye is muted in comparison to systemic administration of a virus.

Potential problems with gene therapies come primarily in the body’s immune response to the virus being used. Immunogenicity can be elicited, which eliminates the virus before it reaches its target and can also cause major side effects.

Early on in gene therapy developments a patient, Jesse Gelsinger, died in a clinical trial and regulatory bodies have since been very cautious with the approach.

Adeno-associated viruses (AAV) are not known to cause any human disease, and illicit a muted immune response. They have been well characterized in human studies. Safety and efficacy has been substantiated in ocular studies. For these reasons, RetroSense will advance with an AAV vector.

Status of Development

Channelrhodopsin-2 is a very well characterized protein. Numerous studies have been published supporting the protein’s efficacy(2, 3, 4) and safety (5, 6)  in vision restoration. Published mouse, rat, and marmoset studies support efficacy. Additional published studies support the safety – including neurotoxicity and immunogenicity. In order to enter into human clinical trials, however, RetroSense will be required to perform a battery of safety tests under “Good Laboratory Practices” as established by FDA guidelines.

While RetroSense cannot divulge details on just where they are in the pre-clinical process, the company suggests they could be in human clinical trials in less than two years. Much like the LCA trials recently published, RetroSense expects to see signs of efficacy in a short time frame (as little as two months), with a small number of patients. As drug development goes, this is actually a very short timeline.


Alternative Therapies Under Development for RP and Dry AMD

As a means of putting gene therapy into perspective as one of the many approaches that are being developed for the ophthalmologist’s armamentarium for treating RP and dry AMD, I have included the following information about the state of research for other experimental techniques/therapies that may find use in treating these diseases.

For RP:

The prime therapies for treating RP are gene therapy, described above; retinal implants; and the use of stem cells. The two latter therapies will be discussed below. Plus, at least one drug therapy is under evaluation, as noted below.

Retinal Implants (7, 8)

This discussion is taken almost entirely from Wikipedia. For more information about retinal implants and their technology, please see the excellent review article by Dr. Raymond Iezzi, recently published in Review of Ophthalmology (Reference 8).

A retinal implant is a biomedical device meant to partially restore useful vision to people who have lost theirs due to degenerative eye conditions such as retinitis pigmentosa or macular degeneration. Retinal implants are currently being developed by more than fifteen companies and research institutions in more than six countries worldwide.

The various technologies used in the implants consist of : 1) an array of electrodes implanted on the retinal surface; 2) a digital camera worn on the user's body and, 3) a transmitter/image processor that converts the image to electrical signals and beams them to the electrode array in the eye. The technologies, while still rudimentary, allow the user to see a scoreboard type image made up of bright points of light viewed from about arm's length. The developments are currently aimed only at the disabled, however, this technology once perfected, could revolutionize the personal computing and cyborg industries.

There are two types of retinal implants currently showing promise in clinical trials: Epiretinal Implants (on the retinal surface) and Subretinal Implants (within or behind the retina).

Epiretinal Implants sit on top of the retina, directly stimulating ganglia using signals sent from the external camera and power sent from an external transmitter, whereas Subretinal Implants sit under the retina, stimulating bipolar or ganglion cells from underneath. Some subretinal implants use signals and power from external circuitry, while others use only incident light as a power source and effectively replace damaged photoreceptors leaving all other structures within the eye untouched.

Clinical trials with chronic or semi-chronic (one-month) implant durations are currently under way in the United States and Europe. Patients with epiretinal stimulators have the ability to detect light, can ambulate along a white line painted on the floor, have demonstrated object avoidance, and some subjects can identify large letters on a computer screen with high accuracy. In addition, subretinal devices tested in Europe have provided 20/1200 visual acuity in a single subject.

Retinal prosthesis technology has been in development for more than two decades. Early devices are currently in clinical trials and are demonstrating exciting results.

A few of the major efforts in this field include:

●    The Boston Retinal Implant Project - external objective (eyeglasses) and subretinal implant
●    Retina Implant AG, in Germany - subretinal implant
●    Second Sight Medical Products - epiretinal implant

Retinal Implant AG

Retina Implant AG presented its latest clinical results at the recent American Association of Ophthalmology Meeting’s Retina Subspecialty Day on October 16th, “Subretinal Implants for Retinitis Pigmentosa”. The presentation discussed findings from Retina Implant's first clinical trial which began in November 2005 and involved implanting 11 patients with a 1500 electrode microchip subretinally. Dr. Walter Wrobel, CEO of the company, explained how the trial was carried out, the subretinal technique to implantation, and the visual results achieved by patients including the ability to recognize foreign objects and read at a basic level.

The company also discussed the technical and clinical results obtained during that first human clinical trial following the results being published in the Proceedings of the Royal Society B on November 2, 2010. That study titled, "Subretinal electronic chips allow blind patients to read letters and combine them to words," (9) details the visual results achieved during the first clinical trial. Patients in the trial were able to recognize foreign objects and read letters to form words. The study concluded that the implantation of Retina Implant's microchip was successful in restoring useful vision in patients previously blind due to retinitis pigmentosa.

Implant position in the body. (a) The cable from the implanted chip in the eye leads under the temporal muscle to the exit behind the ear, and connects with a wirelessly operated power control unit. (b) Position of the implant under the transparent retina.

Editors Note: The photograph can be enlarged for easier reading by opening it in a new tab or browser window.


"The stellar results achieved during our first clinical trial validate our subretinal approach to implantation which we believe is the key to restoring useful vision for patients blinded by retinitis pigmentosa. As we continue on with our second clinical trial, we look forward to expanding on the lessons learned during our first trial by following patients as they return home."

Retina Implant began their second clinical trial earlier this year in Germany with plans to expand the trial to other European countries including the U.K. and Italy. In this clinical trial patients will receive the 1500 electrode implant permanently. Pending positive results from their second clinical trial, Retina Implant intends to submit the results for CE mark approval (for marketing in Europe).

Early Development Project

One other interesting project, in the early stages of development, involves  research  based at Boston College and the University of Massachusetts Medical School, that is attempting to create nano-structured retinal implants. The visual prosthesis is based on a novel, nanostructured, biocompatible energy conversion device whose dimensions enable the density of implanted stimulating electrodes to exceed 100 million/cm2.  This constitutes by far the highest pixelation for a retinal implant, tens of thousands of times higher than any competing device, comparable even to the rods and cones in the retina that the implant will replace. Moreover, the novel "nanocoax" architecture of the neuroprosthesis enables unprecedented light-to-energy conversion efficiency.  It also establishes a new paradigm for retinal implant technology: ambient light operation, without the need for implanted batteries or wires.

According to the latest information from the inventor of the above nanostructered device, the research team is still awaiting funding to get this concept off of the ground.


Stem Cells

In my recently published Primer on the Use of Stem Cells in Ophthalmology, I pointed out that at least three of the seven companies targeting the use of stem cells for retinal diseases had mentioned RP as one of their targets. The three specific references were the programs at Scripp’s Research Institute, sponsored by Pfizer Regenerative Medicine; the program at Oregon Health & Science University, sponsored by Stem Cells, Incorporated; and the program at the Fyodorov Eye Microsurgery Center in Moscow, sponsored by Stemedica. (All three programs, by the way, are using adult stem cells.) No further information is available at this time.


Drug Therapy

At least one drug therapy is under evaluation for treating RP.  Neurotech Pharmaceuticals, Inc., has announced that the company's lead product candidate, NT-501 has demonstrated a strong biologic effect in two Phase 2 clinical trials in the treatment for retinitis pigmentosa (RP).

NT-501 is an intraocular implant that consists of human cells that have been genetically modified to secrete ciliary neurotrophic factor (CNTF). CNTF, a growth factor capable of rescuing and protecting dying photoreceptors, is delivered directly to the back of the eye in a controlled, continuous basis by means of the company's proprietary Encapsulated Cell Technology (ECT) platform.  Delivery via ECT bypasses the blood-retinal barrier and overcomes a major obstacle in the treatment of retinal disease.

"CNTF has the potential to help people with retinitis pigmentosa and other photoreceptor degenerations," said Dr. Paul Sieving, Director of the National Eye Institute and Principal Investigator of Neurotech's Phase 1 study of NT-501 in RP. "These studies are important as they present an opportunity to move the field forward."

However, it was noted in the news release about the test results that no visual benefit was seen in the treated eye relative to the control eye over this relatively short 12-month time period. So, it appears that photoreceptor preservation occurs, but no regeneration or improvement in sight using this implant – at least to date.


For Dry AMD:

The treatment of dry AMD is under study from many fronts, because of it’s presence in so many patients. The main approaches, in addition to gene therapy discussed briefly above, are both externally applied drops and injected drugs, including sustained release types; stem cells; and retinal regeneration using both a laser to stimulate regeneration of retinal pigmented epithelial (RPE) cells, and a combination of laser and stem cells. These will be discussed briefly below.

Therapeutic and Sustained Drug Release

I have published two articles in my online Journal on the subject of drug therapies for retinal diseases, including dry AMD, one of which is specific for the treatment of dry AMD. My AMD Update 6: An Overview of New Treatments for Dry AMD, by Dr. Philip Rosenfeld, addresses the preclinical and Phase I drugs in development for dry AMD; while my writeup on Iluvien and the Future of Ophthalmic Drug Delivery Systems discusses sustained-release drug delivery systems, a few of which are aimed at treating dry AMD.

The three FDA-approved sustained-release systems are Vitasert (for cytomegalovirus retinitis); Retisert (for uveitis); and Ozurdex (for macula edema following branch or central retinal vein occlusion). Iluvien (for diabetic macula edema) is expected to achieve FDA marketing approval before the end of this year. It is also being tested as a treatment for both dry AMD and geographic atrophy, which occurs during the latter stages of dry AMD.

Several other drugs, mentioned in both of the articles noted above, are under evaluation for treating dry AMD, and at least one, from Neurotech, as noted above in the RP writeup, for treating RP


Stem Cells

Again, as noted in my recently published Primer on the Use of Stem Cells in Ophthalmology,  six of the seven companies are targeting the dry stage of AMD with their stem cell programs. Two of the efforts are with human embryonic stem cells, one uses induced pluripotent stem cells, and the remainder are using adult stem cells. It is interesting to note that one program, that sponsored by Stemedica, at the Moscow-based Fyodorov Eye Institute, is attempting to use the injection of stem cells following spot laser damage of the retina.

It should be noted that to date, no FDA-approved human clinical trials using stem cells to treat retinal diseases has begun. However, this is about to change. The first human trials for retinal diseases are scheduled to begin, either in the fourth quarter of this year (for Stargart’s by Advanced Cell Technology) or in the first quarter of next year (for dry AMD by The London Project to Cure Blindness, sponsored by Pfizer Regenerative Medicine).


Retinal Regeneration

In late 2007, I learned of a new, potential laser treatment, under development for treating retinal diseases. It was the Ellex 2RT program, using  a specially designed laser to treat retinal pigment epithelial cells, to stimulate the RPE cells to release enzymes that are capable of “cleaning” Bruch’s membrane, thereby rejuvenating the retina by allowing the increased transport of water and chemicals across this important membrane. In doing so, it is hoped that this will alleviate some of the debris (drusen) associated with the early stages of dry AMD. The technology behind this therapy is described in more detail in my first writeup, Ellex 2RT Retina Regeneration Therapy: A First Report.

In two later reports, I wrote about the first clinical results with this laser treatment (Ellex 2RT Retinal Regeneration Laser: An Update – First Clinical Results), which showed improved visual acuity in patients treated with newly diagnosed diabetic maculopathy and/or macula edema; and then earlier this year, following the ARVO meeting, the results of two key pilot studies, one on patients with proliferative diabetic retinopathy, and the other on patients with early (dry) AMD (Ellex 2RT Updated Clinical Results: ARVO 2010). In the latter study, of interest to this program,  after six months, ten of fourteen eyes had improved in visual function (six eyes) or drusen reduction (ten eyes). One-year results were expected to be reported at the AAO Meeting in late October. (As of the date that this report is being written, I have not received any verification that this occurred.)


Other Applications of Gene Therapy in Ophthalmology

Significant advancements have been made in understanding the genetic pathogenesis of ocular diseases, and gene replacement and gene silencing are being shown as potentially efficacious therapies. Recent improvements have been made in the safety and specificity of vector-based ocular gene transfer methods. Proof-of-concept for vector-based gene therapies has also been established in several experimental models of human ocular diseases. After nearly two decades of ocular gene therapy research, preliminary successes are now being reported in phase 1 clinical trials for the treatment of Leber congenital amaurosis.

The review article, “Gene Therapy for Ocular Diseases” (British Journal of Ophthalmology, August 2010) (BJO), describes current developments and future prospects for ocular gene therapy.

“Novel methods are being developed to enhance the performance and regulation of recombinant adeno-associated virus- and lentivirusmediated ocular gene transfer. Gene therapy prospects have advanced for a variety of retinal disorders, including retinitis pigmentosa, retinoschisis, Stargardt disease and age-related macular degeneration. Advances have also been made using experimental models for non-retinal diseases, such as uveitis and glaucoma. These methodological advancements are critical for the implementation of additional gene-based therapies for human ocular diseases in the near future.”

During my research for this writeup, I discovered a unique program underway at Genzyme, that combines the anti-VEGF properties of a drug like Lucentis (Genentech) with gene thearapy, to produce, hopefully, a longer acting effect of the anti-VEGF factor in treating the wet form of AMD.

As described in Technology Review (10), Lucentis binds to and neutralizes a wound-healing growth factor known as VEGF. This binding action stalls the excess growth of blood vessels in the eye that characterizes (the wet form of) age-related macular degeneration. Genzyme's gene therapy drug, officially called AAV2-sFLT01, would insinuate itself into the patient's retinal cells to produce the same VEGF-binding protein as Lucentis over far longer periods – (perhaps) up to several years.

A phase 1 clinical trial of Genzyme's gene therapy treatment began at the end of May. Three patients received the treatment, according to Sam Wadsworth, a Genzyme group vice president in charge of gene and cell therapy. Preliminary results should be available in about a year.

Genzyme  is collaborating with Applied Genetic Technologies Corp., in developing the gene therapy drug.

The only other ocular disease that I will discuss in detail in this article is Leber’s congenital amaurosis. I will leave the others for another time.


Lebers Congenital Amaurosis (11, BJO))

Leber’s congenital amaurosis (LCA), is a rare form of inherited blindness caused by retinal degenerative disease that strikes in infancy and causes a severe loss of vision. Leber congenital amaurosis (LCA), an autosomal recessive disorder that affects both rods and cones, has been linked to at least 14 genes. Several have been demonstrated as potentially efficacious gene therapy targets. The use of the gene RPE65 in an adeno-associated virus (AAV2/2) vector or carrier has been shown to restore rod photoreceptor function and vision-dependent behavior in some of the patients so treated.

Researchers in the United States (12)(13) and the United Kingdom (14) have injected one eye of LCA patients with a harmless virus carrying a gene coding for an enzyme needed to make a lightsensing pigment. In the first completed trial, the light sensitivity of all 12 partially blind patients improved. Four children gained enough vision to play sports and stop using learning aids at school. (Another team using a similar approach gave full color vision to squirrel monkeys born with red-green colorblindness.(15))

At least three Clinical Trial are currently underway (BJO). In one  dose-escalation study involving 12 patients and performed by Malone et al (reference 102 in BJO) safety and efficacy were sustained for at least 2 years post-treatment.

RPE65 gene therapy for LCA has been one of the most successful examples of gene therapy for ocular diseases to date.


In Conclusion

To date, there are no approved treatments for retinitis pigmentosa and/or dry AMD. As shown above, gene therapy holds much promise for RP and, hopefully, for dry AMD as well.

With stem cell therapy about to begin human clinical trials for both Stargardt’s (Advanced Cell Technology) and dry AMD (UCL-London Project to Cure Blindness – Pfizer), and Retinal Regeneration not far behind, it will be interesting to see which new technology/therapy wins the race for treatment of these ocular diseases.


Resources:

The RetroSense Website


Gene Therapy in Ophthalmology
Uthra S, Kumaramanickavel G. “Gene therapy in ophthalmology”, Oman J Ophthalmol 2009; 2:108-10.

Gene Therapy for Ocular Diseases
Liu, Melissa M; Tuo, Jinsheng; Chan, Chi-Chao; “Gene therapy for ocular diseases”; Br J Ophthalmol doi:10.1136/bjo.2010.174912 (BJO)

Gene Therapy Turns Foes into Friends
Abelson, Mark B., Tzekov, Radouil T., Howe, Amanda; “Gene Therapy Turns Foes into Friends”,  Review of Ophthalmology - August 2009


References:

1. Evaluation of AAV-Mediated Expression of Chop2-GFP in the Marmoset Retina, Ivanova E, Hwang GS, Pan ZH, Troilo D, Invest Ophthalmol Vis Sci, May 2010.

2. Ectopic expression of a microbial-type rhodopsin restores visual responses in mice with photoreceptor degeneration, Bi A, Cui J, Ma YP, et al, Neuron 50 (1): 23-33, April 2006.

3. Channelrhodopsin-2 gene transduced into retinal ganglion cells restores functional vision in genetically blind rats. Tomita, et al, Exp Eye Res. 2010 Mar;90(3):429-36. Epub 2009 Dec 27.

4. Evaluation of AAV-mediated expression of Chop2-GFP in the marmoset retina, Ivanova, et al, Invest Ophthalmol Vis Sci. 2010 Oct;51(10):5288-96. Epub 2010 May 19.

5. Evaluation of the adeno-associated virus mediated long-term expression of channelrhodopsin-2 in the mouse retina; Ivanova, et al, Molecular Vision 2009; 15:1680-1689

6. Systematic and Local Responses of Channelrhodopsin-2 Gene Therapy; Sugano, et al, ARVO Poster #A615.

7. Retinal Implants, Wikipedia, February 22, 2010

8. An Inside Look at Retinal Prothesis Technology, Iezzi, Raymond, MD, Review of Ophthalmology, April 2010.

9. Subretinal electronic chips allow blind patients to read letters and combine them to words, Zrenner, Eberhart  M.D et al, Proceedings of the Royal Society B, November 2, 2010.

10. Gene Therapy for Eye Diseases, Weintraub, Karen, Technology Review, July 15, 2010.

11. Gene Therapy Returns, Science, December 18, 2009.

12. Gene Therapy Restores Vision in Leber Congenital Amaurosis, Children's Hospital of Philadelphia news release October 24, 2009

13. Safety and Efficacy Study in Subjects With Leber Congenital Amaurosis, Clinical Trial, NIH, October 21, 2009.

14. Eye gene therapy boost for young, BBC NEWS, August 24, 2009.

15. Colour blindness corrected by gene therapy, Nature, September 16, 2009.


Editors Note: The introduction to this article is now posted in the Special News items on Gene Therapy Net.