NeoVista Presents 24-month Visual Acuity Data Outcomes of Novel Therapy for the Treatment of Neovascular Age-Related Macular Degeneration

NeoVista, Inc. made public today at the Combined Retina Meeting, 24-month data from the company's Phase II study (NVI-111). The study was designed to examine the company's novel epimacular brachytherapy procedure when used in conjunction with Bevacizumab anti-VEGF therapy for the treatment of neovascular age-related macular degeneration (AMD). The long-term data from the study showed that a majority of patients maintained their visual acuity and at least 20% also experienced a marked improvement in vision at month 24. The data also showed that 76 percent of the patients only needed 2 protocol required injections of Avastin® throughout the 24-month period.

"We're excited with the latest data from this Phase II study, said John N. Hendrick, President and CEO of NeoVista. "Safety remains the primary purpose of this study and to date there is no evidence of long-term radiation toxicity at 2 years follow-up, with many patients being followed for as long as 3 years. A large majority of patients in the study maintained their visual acuity over the course of follow-up, while some patients in the trial experienced significant vision gain. We are encouraged by the reduction in the number of injections delivered to patients in this study (mean of 2.4 injections over the 24 month period). This therapy has the potential to decrease treatment burden both for patients and physicians, not to mention the overall financial burden for healthcare systems around the world."

In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers a focused dose of energy directly to the choroidal neovascular lesion without damaging the adjacent healthy retinal vasculature. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epimacular device is less than that from a typical chest x-ray.

The ongoing multicenter feasibility study enrolled 34 trial participants (with a mean age of 72 years) from June 2006 to April 2007 at two centers in Brazil and one in Mexico. These patients, with predominantly classic, minimally classic, or occult (with no classic) choroidal neovascularization (CNV), received a single exposure of epimacular brachytherapy in combination with two intravitreal injections of Avastin, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in. Additional therapy was delivered based upon the investigator's evaluation of disease activity.

There was an expected increase in the incidence (50%) of cataract formation related to the vitrectomy, the surgical procedure performed when administering epimacular brachytherapy. Comparative data was examined to look at outcomes of patients who entered the study with their natural lens versus those who had already undergone cataract surgery. This analysis showed that 80% of patients who had cataract surgery prior to study entry maintained their visual acuity and 30% gained significant vision at 24 months. When comparing to the cohort of patients that entered the study with their natural lens, 65% percent of patients maintained their visual acuity and 20% percent had significant vision gain, highlighting the fact that cataract formation played a role in long term visual acuity data..

There were a limited number of adverse events in the trial which were related to the vitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage), rather than the epimacular brachytherapy. To date, no instances of radiation toxicity have been reported with many patients followed for as long as 3 years.

The data were presented by Pravin U. Dugel, MD, managing partner, Retina Consultants of Arizona, Phoenix, AZ. "The potential of this treatment is enormous", said Dr. Dugel. "I believe that epimacular brachytherapy will be used in combination with the current standard of care to make this treatment more effective by offering a broad spectrum of action. In addition, epimacular brachytherapy may also improve the quality of life for our patients by relieving them from having to receive monthly intraocular injections. The potential impact of epimacular brachytherapy for patients, physicians and the entire healthcare system is prodigious".

NeoVista has recently completed enrollment in the company's first pivotal trial, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that has enrolled 450 subjects at 45 sites worldwide, and is evaluating the safety and efficacy of NeoVista's therapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis® (ranibizumab) versus Lucentis alone.

For more information go to www.maculardegenerationassociation.org

ThromboGenics Completes Patient Enrolment in US Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease

LEUVEN, Belgium, September 24 /PRNewswire-FirstCall/ --

- Enrolment of 326 Patients Completed Ahead of Schedule

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-006 has completed enrolment with a total of 326 patients several months ahead of schedule. The second Phase III study with microplasmin, TG-MV-007, which is recruiting patients in the US and Europe is due to complete enrolment in the first half of 2010 as planned. Enrolment completion in this study means that ThromboGenics is a step closer to becoming a profitable, integrated Company focused on cutting edge ophthalmic medicines.

Microplasmin's Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. This program involves two clinical trials, which are taking place in the United States (TG-MV-006 trial) and Europe and the United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125microg of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.

The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye. Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions such as macular hole formation, and some forms of macular edema. Vitreomacular adhesion is also associated with a much poorer prognosis in certain major eye conditions, including diabetic retinopathy and Age-related Macular Degeneration (AMD).

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using optical coherence tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. ThromboGenics has used both OCT and ultrasound technology in previous studies evaluating microplasmin in eye disease. Based on this experience and discussions with the FDA, OCT was selected as the main assessment technique for the Phase III program as it provides results which have greater clinical relevance. In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period.

It is expected that the results from the TG-MV-006 study will be presented by mid 2010.

Dr. Patrik De Haes, CEO of ThromboGenics commented, "We are very pleased to announce that we have completed enrolment of the US pivotal Phase III trial for microplasmin months ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is very encouraging. Today's announcement brings us a step closer to potentially changing the way a number of important eye conditions are treated, as well as bringing us closer to our key aim of becoming a profitable, integrated business focused on cutting edge ophthalmic medicines. We very much look forward to announcing the results of this trial by the middle of next year and I am confident that ThromboGenics will continue to deliver on the milestones needed to build a strong, successful and profitable Company."

For more information go to www.maculardegenerationassociation.org

Zeaxanthin Supplements Help Prevent Age-Related Macular Degeneration

Author: Lisa Murray

Living longer is what people do now. The number of people suffering from age related disease is on the increase. One of the things people value the most is their sight so what can we do to protect our vision, we can add a supplement called zeaxanthin to our daily diet. Zeaxanthin is a carotenoid found in the central macula of the eye and it helps us to see things straight in front of us such as signs and faces.

A lot of optometrists and ophthalmologists are recommending zeaxanthin supplements for their older patients that are at high risk for age-related macular degeneration. Age-related macular degeneration or AMD is the major cause of blindness in the elderly and simply taking a daily dose of zeaxanthin can help prevent AMD from occurring.

AMD affects 10% of people aged 66-74 years and 30% aged 75-85 years of age. If you have a relative with AMD your chances of developing this disease increase to 50%. Taking a zeaxanthin supplement can change these odds.

Some doctors are recommending zeaxanthin supplements for younger patients as a preventative measure and if doctors are recommending it as a supplement then that lets you see just how important zeaxanthin is to your eyes, your sight and your way of life.

How would it be that, for the sake of one supplement containing 10mg of zeaxanthin you lost your independence, you could no longer see the faces of your family or your favourite books became unreadable. This supplement is more important than ever as we as a society age and demand that we retain our health and our senses while we do so.

Imagine looking at a photograph of a loved one and not being able to see their face. Think about how it would feel to pick up a book or magazine and not be able to read the words right in front of you. Zeaxanthin can help prevent this from happening to you. Imagine your favourite sport, chat show, drama, film or soap opera on the television and not being able to see what was going on in the middle of the screen. Now imagine that you chose a zeaxanthin supplement that suited your needs, took it regularly and made it a part of your health maintenance routine and you won’t have to imagine the loss of your central vision.

Of course zeaxanthin occurs naturally in our eyes and therefore can be found in other places in nature such as fruit and vegetables. Although many of us have improved our diet and take to heart the advice of five portions of fruit and veg each day, this is such an important health issue that it makes sense to ensure that we get enough zeaxanthin into our diet by taking it in supplement form to compliment our healthy eating plans.

As part of what we do we have scoured the supplement market place and found what we believe to be one of the best zeaxanthin supplements currently available. After thoroughly investigating this topic three of our researchers have started taking a zeaxanthin supplement and they are in their thirties. Your sight is something that can be protected from AMD whatever your age, why not start today.

Lisa Murray is an editor of http://www.supersupplementguide.com and is a keen advocate of ensuring your body is properly fueled with the right nutrients in order to give you the healthiest life possible. She does this by taking a carefully balanced multi-vitamin daily. Why not join her today and live life to the fullest for longer.

For more information go to www.maculardegenerationassociation.org

New techniques slow progress of age-related vision loss

(CNN) -- When Albert Budacz was young, he prided himself on having good eyesight; he never wore glasses. But as he eased into his late 40s, he couldn't see as well. "I noticed a change in my vision," he explained. "Primarily in church when I would open a Bible, or something like that, I had to position myself under a light to see it."

Concerned that he was beginning to lose his sight, Budacz went to his ophthalmologist, Dr. Sharon Solomon with the Wilmer Eye Institute at Johns Hopkins. He was found to have the beginnings macular degeneration, an eye condition that occurs when the central portion of the retina -- called the macula -- begins to deteriorate.

Until recently, people with age-related macular degeneration, the leading cause of severe vision loss in Americans older than 60, had few treatment options. But now, thanks to new research and advancing technology, there are more vision-saving choices.

Early signs of macular degeneration-related vision loss include shadowy areas or fuzzy distortion in a person's central vision.

"A patient told me recently that he noticed when he was driving that the streetlights were slanted; the poles themselves were slanted," Solomon said. "That's a classic sign of the beginning of this disease."

Although obesity, smoking, high blood pressure and certain drugs can cause it, age is the primary risk factor.

"As people approach their 50s and later, they may have little yellow deposits that develop underneath the retina, and that's called drusen," Solomon explained. "Those deposits are the hallmark of what we call early age-related macular degeneration."

There are two forms of age-related macular degeneration, or AMD: the dry form, known as non-neovascular, and the wet form, called neovascular.

The dry form, which Budacz has, is more common. According to the National Eye Institute, about 85 to 90 percent of patients with advanced macular degeneration have the dry form.

Dry macular degeneration is caused when drusen begin to accumulate in and around the macula. Drusen, those yellowish deposits, are debris from deteriorating tissue.

With dry AMD, there is usually a gradual loss of central vision. Over a period of years, dry AMD can progress to a gradual deterioration of retinal cells, which can result in severe vision loss or lead to the wet version of AMD.

As of now, there is no FDA-approved treatment for dry macular degeneration, although a few drugs and devices are in clinical trials.

However, studies have shown that supplements and a healthy diet can slow the progression of dry macular degeneration. A recent National Eye Institute study found that certain nutrients such as beta carotene (vitamin A) and vitamins C and E may reduce the risk of progression of early-stage AMD by 25 percent.

Solomon says these antioxidants have a positive effect. "They're known as 'preservision,' " she said, noting that they are commonly given to certain patient groups to slow their progression to advanced macular degeneration.

Other research has shown that B6, B12 and folic acid may help prevent age-related macular degeneration. In a study of more than 5,000 women, researchers noted those who took a combination of B6 and B12 vitamins along with a folic acid supplement had a 34 percent lower risk of developing AMD then those taking a placebo.

Although the studies showed strong results, the American Academy of Ophthalmology cautions patients to talk to their eye doctors about which supplements are best for their condition before they start popping vitamins.

In the wet version of macular degeneration, abnormal blood vessels grow beneath the retina and leak blood and fluid. This leakage causes permanent damage to light-sensitive retinal cells, which die off and create blind spots in central vision.

Doctors say it's the body's misguided way of attempting to supply the retina with more nutrients and oxygen. Instead, the attempt creates scarring, leading to severe central vision loss.

Up until recently, there's been very little doctors could do for the wet form of macular degeneration. But over the past decade, there have been a few treatments developed to slow its progression. Cold lasers are now used to freeze the abnormal blood vessels responsible for destroying the macula; they have a 60 percent success rate.

And within the past three years, researchers pinpointed a protein in the eye, called vascular endothelial growth factor, that stimulates the development of blood vessels.

Injectable drugs that inhibit VEGF are now FDA-approved and available; without VEGF, there is little to encourage the growth of blood vessels in the retina.

"They actually have a 90 percent chance of stabilizing vision and a 30 to 40 percent chance of improving vision," Solomon said. "This is the first therapy that we've had that can actually [reverse] vision loss."

Most ophthalmologists prefer an ounce of prevention to a pound of cure. They promote yearly eye exams as the easiest way to keep macular degeneration in check -- and warn against waiting for a crisis to schedule a checkup.

"We typically pick up a patient when, all of a sudden, they've had an acute, abrupt loss of vision or change in the quality of their vision," Solomon said. "And sometimes it's too late."

Albert Budacz was lucky. He caught his macular degeneration in time. He's stopped smoking and takes antioxidants to slow the progression of the disease. And although he may not have the eyesight he had as a young man, he can still see pretty well with or without glasses. And to him, that's all that matters.

For more information go to: www.maculardegenerationassociation.org

See Clearly With Nutrients

Vision problems plague many people as they get older, and whether it's an inability to read fine print, dry eyes, floaters, or macular degeneration, these impairments interfere significantly with quality of life. That's why for more than a decade I've recommended lutein, zeaxanthin, zinc, bilberry, and other nutrients that target eye health.

These nutrients consistently provide good results-in fact, in just the past month I've heard from three subscribers who began using them. One woman reported that her macular degeneration, a progressive condition that is the leading cause of blindness in older people, is now under control and holding steady. Another says they help with her vision and dry eyes. And a 93-year-old man told me that now his 40-year-old relatives depend on him to read fine print! Look for vision products that contain 15 mg of lutein, 600 mcg zeaxanthin, 50 mg zinc, and 320 mg bilberry, among other nutrients.

Scientists Morph Human Skin Cells Into Retinal Cells

By Molika Ashford

In a stem-cell breakthrough, scientists have illuminated a new way forward in treating diseases of the eye: turning skin cells into eye cells.
The retina is a lush layered field of tissue lining the back of the eye, a complex mix of specialized cells that serve as a transfer station where light signals are absorbed and sent to the brain to be translated into sight.

Researchers from University of Wisconsin, Madison have now created these unique retina cells from lowly skin cells -- opening the possibility that patients with damaged or diseased retinas might some day be able to grow themselves a cure from their own skin.

First, scientists turned the skin cells into IPS cells (induced pluripotent stem cells), the skin-derived stem cells that have emerged as an alternative to embryonic stem cells. Bathed with a cocktail of chemicals, the IPS cells were then morphed into a variety of retinal cells, including the all-important photoreceptors that translate light signals into electrical signals for our brains to parse as vision.

The scientists report that it is exciting not only to be able to create multiple types of retinal cells, but also that the process appears quite similar to normal retinal development (except in a plastic dish). The group also created retinal cells with embryonic stem cells, but the skin cell method offers an advantage -- patients with genetic diseases of the retina could use their skin to grow a crop of diseased retina cells, which could then be subjected to a variety of test treatments in the lab, hopefully hitting on something that works someday.

The cells might also serve as a treatment themselves, whether grown from IPS cells or embryonic stem cells. Previous studies have improved vision in mice by treating their retinas with stem cells, and this development might help extend that research to humans.

Though in a very early stage, the project is a strong step toward new treatments for an array of debilitating vision disorders.

UF reports possible breakthrough on treating macular degeneration

By Diane Chun
Staff writer

Published: Saturday, August 1, 2009 at 5:30 p.m.
Last Modified: Saturday, August 1, 2009 at 5:30 p.m.

A new approach to repairing damaged retinas in mice offers a ray of hope for some two million Americans with an age-related eye condition called macular degeneration.

University of Florida researchers report that they were able to program adult stem cells from mice to transform themselves into vision cells, suggesting a potential treatment for one of the most common causes of vision loss in older people.

In a paper to be published in September's Molecular Therapy, scientists describe how they used a virus carrying a gene that gently pushed cultured adult stem cells toward a fate as retinal cells. When the cultured cells were reintroduced into the mice, they were completely transformed into the desired type of vision cells.

"To our knowledge, this is the first reported use of targeted gene manipulation to specifically program an adult stem cell to become a new cell type," said Dr. Maria Grant, professor of pharmacology and therapeutics in the UF College of Medicine.

Ultimately, Grant said, the findings suggest that the same thing could be done with drugs.

"You would not give the drugs to the patient," she explained, "you would give the drugs to their cells. Take the cells out, activate certain chemical pathways, then put the cells back into the patient."

The researchers were able to use chemical compounds that mirrored environmental conditions in the body to point the stem cells toward their ultimate identities as vision cells.

In essence, they were successful in tricking the stem cell into thinking it is a retinal cell and behaving accordingly.

"This implies a whole new field of stem cell research that uses drug manipulation rather than genetic manipulation to send these immature cells along a new pathway," said Grant.

She collaborated in the work with Edward Scott, director of the program in stem cell biology and regenerative medicine at UF's McKnight Brain Institute.

"This work applies to 85 percent of patients who have age-related macular degeneration," Grant said. "There are no therapies for this devastating disease."

for more information contact www.maculardegenerationassociation.org