HUENENBERG, Switzerland -- Alcon, Inc. (NYSE:ACL) announced today it has terminated the development program designed to evaluate the benefit of anecortave acetate treatment on the risk for developing sight-threatening choroidal neovascularization secondary to age-related macular degeneration. The decision followed a planned interim analysis of studies C-02-60 A and B that was performed after 2,546 patients had completed the 24 month time point. In this analysis, anecortave acetate showed no effect on the primary or secondary endpoints. In addition to terminating studies C-02-60 A and B, the company also terminated two smaller studies with an identical design that were being conducted in Asia, C-04-30 and C-05-34.
The company continues to study anecortave acetate administered as an anterior juxtascleral depot to reduce intraocular pressure in patients with open-angle glaucoma.
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of approximately $5.6 billion in 2007. Alcon, which has been dedicated to the ophthalmic industry for more than 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. For more information on Alcon Inc., visit the company's Web site at www.alcon.com.
Tuesday, July 20, 2010
Monday, July 12, 2010
Artificial Retina offers new Hope
TUCSON - There is new hope for millions of people losing their vision. Many are going blind because of age-related macular degeneration and other conditions. But a new device called Artificial Retina has people seeing and believing.
Dean Lloyd is one of 14 people in the United States seeing through an Artifical Retina. He lost his vision in 1974. Lloyd says, "I almost lost all my vision in six months." Then in 2007, after a three hour operation, his sight, though limited, returned. "The beauty of the human brain is when you've had sight at one time, the brain seems to save the images," he said.
The camera on Dean's glasses captures an image and sends it wirelessly to an implant in his eye that stimulates his optic nerve to create an image in his brain. The next generation for Dean's implant is one that could help him see details and faces.
Satinderpall Pannu heads the Artificial Retina project at Lawrence Livermore labs in California. Starting with a silicon wafer and a thin coating of polymer, the disk is processed, electrodes are added and the implant is encased in titanium and gold, "It's a very rewarding feeling. It's amazing to me that technology that we've developed here at the lab can actually restore someone's sight," Pannu said.
Pannu says in 10 years, 50 million people in the world will suffer from blindness that these implants could reverse, "We really would like to take this tech to have a digital camera embedded in your retina and be able to restore your vision completely."
The only clinical trials for the artificial retina in the U.S. are run through a California Company "Second Sight."
Project leaders at Lawrence Livermore say they only have funding through next year. Right now, they're trying to lobby congress to extend the project's 8-million dollar a year budget, to improve the implant.
Dean Lloyd is one of 14 people in the United States seeing through an Artifical Retina. He lost his vision in 1974. Lloyd says, "I almost lost all my vision in six months." Then in 2007, after a three hour operation, his sight, though limited, returned. "The beauty of the human brain is when you've had sight at one time, the brain seems to save the images," he said.
The camera on Dean's glasses captures an image and sends it wirelessly to an implant in his eye that stimulates his optic nerve to create an image in his brain. The next generation for Dean's implant is one that could help him see details and faces.
Satinderpall Pannu heads the Artificial Retina project at Lawrence Livermore labs in California. Starting with a silicon wafer and a thin coating of polymer, the disk is processed, electrodes are added and the implant is encased in titanium and gold, "It's a very rewarding feeling. It's amazing to me that technology that we've developed here at the lab can actually restore someone's sight," Pannu said.
Pannu says in 10 years, 50 million people in the world will suffer from blindness that these implants could reverse, "We really would like to take this tech to have a digital camera embedded in your retina and be able to restore your vision completely."
The only clinical trials for the artificial retina in the U.S. are run through a California Company "Second Sight."
Project leaders at Lawrence Livermore say they only have funding through next year. Right now, they're trying to lobby congress to extend the project's 8-million dollar a year budget, to improve the implant.
Wednesday, July 7, 2010
Miniature Telescope for Eye Approved for Macular Degeneration
TUESDAY, July 6 (HealthDay News) -- A tiny telescope that's implanted in an eye affected by advanced age-related macular degeneration (AMD) has been approved by the U.S. Food and Drug Administration.
The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.
The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.
More information
To learn more about AMD, visit the U.S. National Eye Institute.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.
The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.
The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.
More information
To learn more about AMD, visit the U.S. National Eye Institute.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.
Wednesday, June 30, 2010
Alimera seek NDA for diabetic macular degeneration drug/device combo
June 29, 2010 by MassDevice staffpSivida Corp. and Alimera Sciences file a new drug application with the Food & Drug Administration for Iluvien, a drug/device combination aimed at treating diabetic macular degeneration.
pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.
Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.
Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.
There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.
The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.
"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."
The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.
For more information go to www.maculardegenerationassociation.org
pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.
Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.
Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.
There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.
The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.
"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."
The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.
For more information go to www.maculardegenerationassociation.org
Thursday, June 10, 2010
Researchers create retina from embryonic cells
By Adrian Galbreth
Researchers in the US have successfully created a retina from human embryonic stem cells, which offers hope to millions with degenerative eye disorders.
Experts at the University of California Irvine created an eight-layer, early stage retina from human embryonic stem cells, which is the first ever three-dimensional tissue structure to be made from stem cells.
Study leader Hans Keirstead of the Reeve-Irvine Research Center and the Sue and Bill Gross Stem Cell Research Center at the facility, said the process also marks the first step towards the development of transplant-ready retinas to treat conditions such as retinitis pigmentosa and macular degeneration, a leading cause of blindness.
"We made a complex structure consisting of many cell types. This is a major advance in our quest to treat retinal disease," he explained.
Recently, German research centre Fraunhofer-Gesellschaft claimed that a new implant made of plastic could soon offer patients the chance to see again without having to wait for cornea transplants.ADNFCR-1853-ID-19804594-ADNFCR
Researchers in the US have successfully created a retina from human embryonic stem cells, which offers hope to millions with degenerative eye disorders.
Experts at the University of California Irvine created an eight-layer, early stage retina from human embryonic stem cells, which is the first ever three-dimensional tissue structure to be made from stem cells.
Study leader Hans Keirstead of the Reeve-Irvine Research Center and the Sue and Bill Gross Stem Cell Research Center at the facility, said the process also marks the first step towards the development of transplant-ready retinas to treat conditions such as retinitis pigmentosa and macular degeneration, a leading cause of blindness.
"We made a complex structure consisting of many cell types. This is a major advance in our quest to treat retinal disease," he explained.
Recently, German research centre Fraunhofer-Gesellschaft claimed that a new implant made of plastic could soon offer patients the chance to see again without having to wait for cornea transplants.ADNFCR-1853-ID-19804594-ADNFCR
Wednesday, June 2, 2010
New Drugs for Macular Degeneration
By Emily Singer
Two genetic studies of people with age-related macular degeneration (AMD)--the most common cause of blindness in people older than 65--made a surprising discovery. Research showed that defects in a gene that is an important regulator of parts of the immune system significantly increased risk of the disease. Scientists have since identified variants in several related genes that also boost risk, and which collectively account for about 50 to 60 percent of the heritability of the disorder.
At the same time that researchers identified the harmful variation linked to AMD, Gregory Hageman, now at the University of Utah, identified a protective variant found in about 20 percent of the population. "That form is so incredibly protective that people with two copies are almost guaranteed not to develop the disease," he says. Hageman founded Optherion, a startup based in New Haven, CT, and investigated how to translate the findings into new treatments. Optherion is now producing large quantities of an engineered version of the protein and doing preclinical safety and effectiveness testing--for example, examining whether the treatment can reduce ocular deposits in mice that lack the protein, says Colin Foster, Optherion's president. He declined to estimate when the company will begin clinical trials of the drug.
Scientists hope that these developments will prove to be an example of the benefits that can arise from a type of genetic study called genome-wide association. The genome-wide studies of macular degeneration were among the first and perhaps the biggest success for the approach, which employs specially designed chips dotted with markers to cheaply detect hundreds of thousands of the most common variations in the human genome. While these chips have allowed scientists to cheaply scan the genomes of many patients and healthy controls, the approach has come under increasing scrutiny in the last couple of years. Even huge studies of thousands of people have failed to identify the majority of the heritability of common diseases, such as type 2 diabetes or Alzheimer's disease.
Two genetic studies of people with age-related macular degeneration (AMD)--the most common cause of blindness in people older than 65--made a surprising discovery. Research showed that defects in a gene that is an important regulator of parts of the immune system significantly increased risk of the disease. Scientists have since identified variants in several related genes that also boost risk, and which collectively account for about 50 to 60 percent of the heritability of the disorder.
At the same time that researchers identified the harmful variation linked to AMD, Gregory Hageman, now at the University of Utah, identified a protective variant found in about 20 percent of the population. "That form is so incredibly protective that people with two copies are almost guaranteed not to develop the disease," he says. Hageman founded Optherion, a startup based in New Haven, CT, and investigated how to translate the findings into new treatments. Optherion is now producing large quantities of an engineered version of the protein and doing preclinical safety and effectiveness testing--for example, examining whether the treatment can reduce ocular deposits in mice that lack the protein, says Colin Foster, Optherion's president. He declined to estimate when the company will begin clinical trials of the drug.
Scientists hope that these developments will prove to be an example of the benefits that can arise from a type of genetic study called genome-wide association. The genome-wide studies of macular degeneration were among the first and perhaps the biggest success for the approach, which employs specially designed chips dotted with markers to cheaply detect hundreds of thousands of the most common variations in the human genome. While these chips have allowed scientists to cheaply scan the genomes of many patients and healthy controls, the approach has come under increasing scrutiny in the last couple of years. Even huge studies of thousands of people have failed to identify the majority of the heritability of common diseases, such as type 2 diabetes or Alzheimer's disease.
Thursday, May 27, 2010
Decreased antioxidant levels increase risk of age-related macular degeneration with exposure to sunlight
The journal Archives of Ophthalmology recently reported that having reduced plasma antioxidant levels and increased exposure to sunlight increases the risk of neovascular, or advanced age-related macular degeneration (AMD).
In a recent study (titled the European Eye Study), over 4,400 participants over age 65 were analyzed for the presence of macular degeneration. Their blood plasma was evaluated for vitamins C and E, the carotenoids lutein and zeaxanthin, and the mineral zinc. Each individual also completed a questionnaire regarding their typical exposure to sunlight. This was used to estimate blue light exposure from visible light, which is known to contribute to the development of macular degeneration.
Early stage macular degeneration was detected in 2,182 participants, and 101 had the advanced form of the disease. The research found no association between blue light exposure and early macular degeneration. However, among participants in the lowest quartile (25 percent) of serum vitamin C, zeaxanthin, vitamin E and zinc, exposure to blue light significantly increased the risk of advanced macular degeneration.
In a recent study (titled the European Eye Study), over 4,400 participants over age 65 were analyzed for the presence of macular degeneration. Their blood plasma was evaluated for vitamins C and E, the carotenoids lutein and zeaxanthin, and the mineral zinc. Each individual also completed a questionnaire regarding their typical exposure to sunlight. This was used to estimate blue light exposure from visible light, which is known to contribute to the development of macular degeneration.
Early stage macular degeneration was detected in 2,182 participants, and 101 had the advanced form of the disease. The research found no association between blue light exposure and early macular degeneration. However, among participants in the lowest quartile (25 percent) of serum vitamin C, zeaxanthin, vitamin E and zinc, exposure to blue light significantly increased the risk of advanced macular degeneration.
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