A first-time finding of intraocular pressure increases in patients with no personal or family history of glaucoma following anti-VEGF treatment for wet age-related macular degeneration (AMD), and a report on a simple, low-cost method that could revolutionize vision screening and treatment in developing countries, are highlights of today's Scientific Program of the 2009 Joint Meeting of the American Academy of Ophthalmology (AAO) and the Pan-American Association of Ophthalmology (PAAO).
The AAO-PAAO meeting is in session October 24 through 27 at the Moscone Center, San Francisco, CA. As the largest, most comprehensive ophthalmic education conference in the world, it offers United States and international Eye M.D.s more than 2,000 scientifically-based, peer-reviewed presentations including instruction courses, skills labs, "Breakfast with the Experts" roundtables and 900 research papers and posters.
Wet Macular Degeneration Treatment May Increase Intraocular Pressure
Some patients with age-related macular degeneration (AMD) develop elevated pressure within the eye (intraocular pressure, IOP) following treatment with anti-VEGF medications bevacizumab and/or ranibizumab, reports a Yale University School of Medicine study led by Ron A. Adelman, MD, MPH. Both of these anti-VEGFs control the abnormal growth of blood vessels in the eye's retina and are very effective against wet AMD, which can result in vision loss or blindness if untreated. But high IOP is a key factor in glaucoma, also a potentially blinding disease. Of 116 Yale study patients treated for wet AMD with either or both medications from 2006 to 2008, 3.45 percent (four patients) developed a significant and persistent rise in IOP.
"To our knowledge, ours is the first study to document persistent ocular hypertension (OHT) following intravitreal bevacizumab injections in patients with no personal or family history of glaucoma or ocular hypertension (OHT)," Dr. Adelman said. "We found that sustained, high IOP may occur after only one anti-VEGF injection, but more typically after multiple injections. Patients' OHT may continue over several AMD treatments and may require IOP-lowering therapy," he added.
The researchers also reviewed a report by S.F. Bakri and colleagues on persistent OHT after ranibizumab treatment. Of eight OHT patients total in the two studies, four had received a YAG posterior capsulotomy (a procedure related to cataract surgery) prior to wet AMD treatment, which might have predisposed them to OHT, Dr. Adelman said.
New Screening Method Could Mean Clear Vision for Millions
More than 150 million people globally–particularly in developing countries–struggle with poor vision because they cannot access appropriate eyeglasses. Earlier studies indicated that many could not meet the 20/60 vision driver's license standard, a level of impairment that makes daily tasks and economic success difficult. Seeking a low-cost solution, Thomas S. Shane, MD, Bascom Palmer Eye Institute, University of Miami, developed a method that uses a new electronic device called an auto-refractor, a vision chart, and pre-made eyeglasses.
Dr. Shane tested this method in high-poverty Mayan villages in southern Belize. Local health workers recruited people, and everyone over age 12 who came to the clinic within a five-day period was tested. In less than a minute per patient the auto-refractor assessed vision and reported the patient's lens prescription. Of 385 villagers screened 79 needed eyeglasses. Each person received new, pre-made eyeglasses with the appropriate lens strengths; then vision was tested again. On average, vision improved from 20/60 without glasses to 20/25 with glasses.
"This method requires minimal health care worker training and treatment time per patient," Dr. Shane said. "Costs are further minimized because eyeglasses with a range of lens prescriptions to treat the most common refractive errors could be produced and shipped in bulk. Compared to current practices in developing countries, our method may be much more effective, especially where the need is great but resources are limited."
For more information go to www.maculardegenerationassociation.org
Tuesday, October 27, 2009
Thursday, October 22, 2009
Bionic Eye Opens New World Of Sight For The Blind
Stem cells and electronics can help restore vision to people who’ve been blinded by retinal diseases, scientists reported in Chicago at Neuroscience 2009, the annual meeting of the Society for Neuroscience.
Diseases of the retina cause blindness by damaging the cells that line the back of the eye, where images of the world are normally transformed into nerve impulses that go to the brain.
“There’s very little therapeutic treatment out there tight now for people with diseased retinas,” says Brian Mech, a vice president of Second Sight Medical Products in Sylmar, Calif.
But Second Sight is hoping to change that. The company has developed an experimental bionic eye that has been tried in more than 30 patients with macular degeneration or retinitis pigmentosa.
Building An Artificial Retina
Each patient wears a pair of glasses that incorporates a video camera, Mech says. The video signal from the camera is sent to an implant on the eye itself, which in turns communicates with an array of electrodes attached to the patient’s retina.
And those electrodes do what the old retina can’t anymore: send electrical signals to the brain that allow sight.
Mech says it usually takes patients’ brains a little while to make sense of the new signals.
“They learn to use the device better over time,” he says. “Someone that has had the device for a year will do better than they did at three months.”
The artificial eye uses just 60 electrodes to replace millions of retinal cells. Mech says that means vision is rudimentary.
So people can find doors and follow lines on the floor. But most can’t read, and those who can only make out very large letters.
At the neuroscience meeting, Second Sight presented a study showing that patients could use the artificial eye to tell which direction an object was moving.
Despite the limitations of the artificial eye, Mech says patients who’ve gotten one tend to get emotional when they realize they can see even a little bit.
“There’s a lot of crying, a lot of smiling,” he says. “It’s a sensory input that they haven’t had in a very long time, and so they’re excited.”
Growing New Retina Cells
A team led by Robert Aramant of the University of California, Irvine, offered a different approach to restoring sight.
Since the 1980s, Aramant has been working to fix retinas damaged by diseases including macular degeneration and retinitis pigmentosa.
And for several years now, the team has been treating patients using fetal retinal cells. Their approach is to retrieve an intact sheet of fetal retinal cells and transplant the entire sheet into a damaged eye.
The transplanted cells then mature the same way they would in a developing fetus, creating all the layers of a normal retina, Aramant says.
The team has treated just 10 patients so far, because of funding constraints. But Aramant says seven of those patients got better, including one woman whose vision went from 20-800, which is severely impaired, to 20-200, which is good enough for many daily tasks.
After treatment, Aramant says, the woman was able to play computer games, write emails, and read a large-print version of Reader’s Digest.
Also at the meeting in Chicago, scientists presented studies showing ways to create new light-sensitive molecules in the eye, and to use stem cells to grow specific types of retinal cells.
For more information go to www.maculardegenerationassociation.org
Diseases of the retina cause blindness by damaging the cells that line the back of the eye, where images of the world are normally transformed into nerve impulses that go to the brain.
“There’s very little therapeutic treatment out there tight now for people with diseased retinas,” says Brian Mech, a vice president of Second Sight Medical Products in Sylmar, Calif.
But Second Sight is hoping to change that. The company has developed an experimental bionic eye that has been tried in more than 30 patients with macular degeneration or retinitis pigmentosa.
Building An Artificial Retina
Each patient wears a pair of glasses that incorporates a video camera, Mech says. The video signal from the camera is sent to an implant on the eye itself, which in turns communicates with an array of electrodes attached to the patient’s retina.
And those electrodes do what the old retina can’t anymore: send electrical signals to the brain that allow sight.
Mech says it usually takes patients’ brains a little while to make sense of the new signals.
“They learn to use the device better over time,” he says. “Someone that has had the device for a year will do better than they did at three months.”
The artificial eye uses just 60 electrodes to replace millions of retinal cells. Mech says that means vision is rudimentary.
So people can find doors and follow lines on the floor. But most can’t read, and those who can only make out very large letters.
At the neuroscience meeting, Second Sight presented a study showing that patients could use the artificial eye to tell which direction an object was moving.
Despite the limitations of the artificial eye, Mech says patients who’ve gotten one tend to get emotional when they realize they can see even a little bit.
“There’s a lot of crying, a lot of smiling,” he says. “It’s a sensory input that they haven’t had in a very long time, and so they’re excited.”
Growing New Retina Cells
A team led by Robert Aramant of the University of California, Irvine, offered a different approach to restoring sight.
Since the 1980s, Aramant has been working to fix retinas damaged by diseases including macular degeneration and retinitis pigmentosa.
And for several years now, the team has been treating patients using fetal retinal cells. Their approach is to retrieve an intact sheet of fetal retinal cells and transplant the entire sheet into a damaged eye.
The transplanted cells then mature the same way they would in a developing fetus, creating all the layers of a normal retina, Aramant says.
The team has treated just 10 patients so far, because of funding constraints. But Aramant says seven of those patients got better, including one woman whose vision went from 20-800, which is severely impaired, to 20-200, which is good enough for many daily tasks.
After treatment, Aramant says, the woman was able to play computer games, write emails, and read a large-print version of Reader’s Digest.
Also at the meeting in Chicago, scientists presented studies showing ways to create new light-sensitive molecules in the eye, and to use stem cells to grow specific types of retinal cells.
For more information go to www.maculardegenerationassociation.org
Tuesday, October 13, 2009
MacuCLEAR And Mystic Successfully Complete Phase Ib Clinical Trial For Macular Degeneration
MacuCLEAR, Inc. ("MacuCLEAR") and Mystic Pharmaceuticals, Inc., ("Mystic") announced preliminary successful results of a Phase Ib Clinical Trial for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). The preliminary results indicated that MacuCLEAR's MC-1101 drug is safe and well tolerated by study participants, and has a biological effect on blood flow in the back of the retina. Mystic's VersiDoser™ ophthalmic delivery system was used by trial participants to self-administer MC-1101 to the front of the eye during the trial. The study included Proof Of Concept ("POC") indicators. A key finding of the study was the successful migration of the drug to the back of the eye.
"We are very pleased with the groundbreaking results of this study," said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. "We have confirmed the safety of MC-1101 in humans, a primary endpoint for the study." Ralston added, "We are excited about the implications of the proof of concept part of this study. Using special laser Doppler flow instrumentation, we showed MC-1101 gets to the back of the eye and significantly modulates the blood flow in the choroid, the tiny blood vessels in the back of the macula portion of the retina. This study provides additional scientific evidence supporting our theory that restoring blood flow in the choroid will have a positive affect on preventing the progression of this terrible disease that is the leading cause of blindness for people over the age of 50 in the world." MacuCLEAR will publish the full results of study later this year.
Mystic Pharmaceuticals' President and CEO, Timothy Sullivan, stated, "We are pleased to have partnered with MacuCLEAR to develop a drug/delivery system combination that has the potential to provide a simpler, safer and ultimately cost effective solution to the millions of people suffering from this disease." Ralston added that, "Mystic's delivery system provided key benefits for both MacuCLEAR and the trial participants. Mystic's novel unit dose approach to packaging each eyedrop individually enabled us to use a preservative free formulation and the control Mystic's technology provides for calibrated precision dose delivery and spray plume definitely enhanced absorption of the drug to the back of the eye." Patients were able to safely and effectively self-administer MC-1101 throughout the trial using the VersiDoser system. "An overwhelming majority of the trial participants expressed a strong positive preference for using the VersiDoser Delivery System over traditional eye drop delivery," Sullivan concluded. Mystic will publish study results of trial participant preferences for its VersiDoser Delivery System later this year.
Ralston and Sullivan presented a summary of the trial results at the Texas Emerging Technology Fund Investment Symposium on October 8, 2009 at the Renaissance Hotel in Richardson, Texas. MacuCLEAR and Mystic presented the status of the progress of their companies at this symposium featuring companies that have received investments from the State of Texas Emerging Technology Fund.
For more information go to www.maculardegenerationassociation.org
"We are very pleased with the groundbreaking results of this study," said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. "We have confirmed the safety of MC-1101 in humans, a primary endpoint for the study." Ralston added, "We are excited about the implications of the proof of concept part of this study. Using special laser Doppler flow instrumentation, we showed MC-1101 gets to the back of the eye and significantly modulates the blood flow in the choroid, the tiny blood vessels in the back of the macula portion of the retina. This study provides additional scientific evidence supporting our theory that restoring blood flow in the choroid will have a positive affect on preventing the progression of this terrible disease that is the leading cause of blindness for people over the age of 50 in the world." MacuCLEAR will publish the full results of study later this year.
Mystic Pharmaceuticals' President and CEO, Timothy Sullivan, stated, "We are pleased to have partnered with MacuCLEAR to develop a drug/delivery system combination that has the potential to provide a simpler, safer and ultimately cost effective solution to the millions of people suffering from this disease." Ralston added that, "Mystic's delivery system provided key benefits for both MacuCLEAR and the trial participants. Mystic's novel unit dose approach to packaging each eyedrop individually enabled us to use a preservative free formulation and the control Mystic's technology provides for calibrated precision dose delivery and spray plume definitely enhanced absorption of the drug to the back of the eye." Patients were able to safely and effectively self-administer MC-1101 throughout the trial using the VersiDoser system. "An overwhelming majority of the trial participants expressed a strong positive preference for using the VersiDoser Delivery System over traditional eye drop delivery," Sullivan concluded. Mystic will publish study results of trial participant preferences for its VersiDoser Delivery System later this year.
Ralston and Sullivan presented a summary of the trial results at the Texas Emerging Technology Fund Investment Symposium on October 8, 2009 at the Renaissance Hotel in Richardson, Texas. MacuCLEAR and Mystic presented the status of the progress of their companies at this symposium featuring companies that have received investments from the State of Texas Emerging Technology Fund.
For more information go to www.maculardegenerationassociation.org
Monday, October 5, 2009
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
"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
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