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Macular Degeneration News

Eylea Injection Approved for
Wet Age-Related Macular Degeneration

TARRYTOWN, N.Y., November 2011 — Also known as VEGF Trap-Eye, the injectable macular degeneration drug Eylea received FDA approval for sale in the United States.

The recommended dosage is 2 mg every four weeks for the first three months, then 2 mg every eight weeks. According to Eylea's manufacturer, Regeneron Pharmaceuticals, the eight-week intervals are twice as long as those for Lucentis, another FDA-approved wet AMD drug.

The most common side effects reported in clinical trials were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters and higher eye pressure, all of which were similar to those of Lucentis, according to Regeneron. At the same time, visual benefits of Eylea were shown to be roughly similar to those of Lucentis.

Please click here to watch a video that explains how vascular endothelial growth factor (VEGF) helps wet AMD develop, which is why these anti-VEGF drugs are used. (Video provided by Regeneron Pharmaceuticals.)

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Taking Aspirin Frequently May Increase Macular Degeneration Risk

AMSTERDAM, November 2011 — A study calculated the odds ratio for age-related macular degeneration (AMD) based on frequency of aspirin use and found that AMD odds rose in people who took aspirin more often.

For 4,691 people age 65 and older, researchers determined the presence of AMD and the frequency of low-dose aspirin use in the group.

Early AMD and wet late AMD were associated with frequent aspirin use, and the odds of having these forms of AMD rose along with the frequency.

In other words, those who took aspirin daily had greater odds for AMD than those who took it weekly or monthly.

"If future studies support our results, then recommendations on aspirin may need to be modified for patients with age-related macular degeneration," said research team leader Paulus T. V. M. de Jong, MD, PhD, in a press release. "It's possible that increased AMD risk may outweigh aspirin's potential protective benefits for some patients, but we need to know more about the impacts of dose, length of use, and other factors before we can say for certain, or make specific recommendations."

No reason was found for the odds increase, and indeed the jury seems to be out until further studies are done. Also, a previous study actually found a correlation between aspirin usage and a lack of AMD in women.

The study report appeared online in September in Ophthalmology.

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myVisionTrack App in Development To Test Vision
Changes in People With Macular Degeneration

DALLAS, August 2011 — An upcoming iPhone/iPod Touch app called myVisionTrack will give macular degeneration and diabetic retinopathy patients the ability to monitor changes in their vision over time. This in turn can help their eye doctor adjust treatment as needed.

The 90-second test displays three circles, one of which is different from the others. You would cover one eye, then touch the circle that looks different. The differentiation becomes more subtle as the test progresses, and your scores are formulated and stored in the device. Then you test the other eye.

If your scores indicate that your vision has changed significantly, then you are instructed to visit your eye doctor.

Usually people with degenerative eye disease use an Amsler grid, which looks like graph paper with a dot in the middle. When focusing on the dot, they may see distortions or blurriness in the lines of the grid, and recording these can help track their vision changes. But the developers of myVisionTrack say their device is twice as sensitive as Amsler grids in detecting subtle vision changes.

Prototypes are still in testing now, and the app is expected to be available sometime in 2012.

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Scientists Make Strides in Determining Risk for
Advanced Macular Degeneration

PORTLAND, Ore., August 2011 — People with early age-related macular degeneration (AMD) may or may not progress to the more advanced form of the disease, but until now there has been no risk assessment model to determine if or when this might happen. With a risk model, eye doctors can plan ahead — determining exam frequency and starting their patients on dietary changes and nutritional supplements.

Recently, researchers at Casey Eye Institute designed a risk assessment model that includes demographic, environmental, genetic and physical factors to determine who is at greatest risk to develop advanced AMD. To do this, they used DNA samples, medical histories and examinations from the Age-Related Eye Disease Study (AREDS).

The final model included variables such as a sum of risk factors in both eyes, two genotypes, very large drusen, smoking, family history of advanced AMD, age and advanced AMD in one eye.

Of the 2,602 participants in the final model who had no advanced AMD at the beginning, 24 percent did develop advanced AMD during follow-up, and up these, 82 percent of those with dry AMD and 56 percent with wet AMD also developed advanced AMD in the other eye. According to the researchers, the model worked well to predict their risk.

A report about this research appeared in August in Archives of Ophthalmology.

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Eylea Receives FDA Panel Recommendation;
One Advantage Is Less Frequent Dosing

TARRYTOWN, N.Y., June 2011 — A new drug called Eylea received a unanimous recommendation from an FDA panel for treatment of wet age-related macular degeneration (AMD).

If Eylea receives final FDA approval in August, it will compete against Lucentis. Both drugs are injected into the eye, but instead of every four weeks with Lucentis, patients would receive Eylea every eight weeks (following three initial doses given every four weeks).

Eylea is the proposed brand name of aflibercept ophthalmic solution, also called VEGF Trap-Eye, and was developed by Regeneron Pharmaceuticals. In clinical trials, it was as safe and effective as monthly Lucentis injections in stopping the progression of AMD and in improving vision. The most frequent side effects included conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage and vitreous floaters.

Regeneron says the less frequent dosing would improve the quality of life for AMD patients and caregivers.

It is unclear what the pricing will be for Eylea. As with Lucentis, it will likely be competing with the much less expensive Avastin, a cancer drug that is similar to Lucentis and is often prescribed off-label for AMD.

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Comparison of Avastin and Lucentis Shows Equal Effectiveness Against Macular Degeneration After One Year

BETHESDA, Md., May 2011 — Lucentis and Avastin are equally effective against age-related macular degeneration (AMD), according to first-year results of the Comparison of AMD Treatments Trials (CATT).

The drug Avastin is used for metastatic colon cancer as well as some other cancers. Avastin is also used off-label for macular degeneration as a less costly alternative to Lucentis, which was approved specifically for AMD in 2006. Genentech makes both drugs; Lucentis is derived from a protein similar to Avastin but was developed specifically for injection into the eye.

"Over 250,000 patients are treated each year for AMD, and a substantial number of them receive Avastin. Given the lack of efficacy data regarding Avastin for AMD treatment, the NEI had an obligation to patients and clinicians to conduct this study," said Paul A. Sieving, MD, PhD, director of the National Eye Institute, in a release.

Before the CATT study, Avastin had not been tested in randomized clinical trials to prove its safety and effectiveness for AMD treatment or to determine proper dosing. The 1,185 patients in the CATT study received one of four treatment regimens: Lucentis monthly or as needed, or Avastin monthly or as needed. To eliminate bias, the ophthalmologists in the study were not told which drug their patients were receiving.

The CATT study yardstick was visual acuity improvement, and after one year the drugs showed no significant difference in effectiveness. There was less visual improvement in the as-needed dosing group (which required four to five fewer injections per year) than in the monthly dosing group, but the NEI considered visual results overall to be excellent.

While adverse events did occur in patients in both drug groups, the study was not designed to determine whether they were linked to the AMD treatments or to other medical conditions or treatments. This will require further study.

The CATT study's first-year results were reported online in the New England Journal of Medicine on May 1. The study will continue for a second year and will provide more information on long-term effects of both drugs on vision and safety.

Please click here to learn more about Lucentis and Avastin.

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Consuming More Vitamin D May Reduce Risk of
Early Macular Degeneration, Says Study

BUFFALO, N.Y., April 2011 — A study has found less risk of developing early age-related macular degeneration (AMD) in women under 75 who consumed the most vitamin D. In fact, those consuming the most vitamin D (such as in milk, fish, fortified margarine and fortified cereal) had a 59 percent lower risk of early AMD than those who consumed the least vitamin D.

The researchers, led by Amy E. Millen, PhD, of the University of Buffalo, checked records of 1,313 women to see if their blood levels of a vitamin D biomarker had any relation to whether they developed early age-related macular degeneration. The biomarker reflects vitamin D exposure from both sunlight and nutritional intake.

Among women younger than 75 years, increased intake of vitamin D from foods and supplements was related to decreased odds of early AMD. However, no relationship was observed between self-reported time spent in direct sunlight and AMD risk.

The study report appeared in the April issue of Archives of Ophthalmology.

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Another Reason To Eat More Fish: Lower Risk of
Macular Degeneration for Women

BOSTON, March 2011 — You may want salmon, mackerel, herring or tuna on your menu at least once a week if you want to reduce your risk for age-related macular degneration (AMD).

Researchers at Brigham and Women's Hospital and Harvard Medical School followed up on 38,022 women during the 10 years after data had been collected on them for the Women's Health Study.

After adjustments for factors including age, they found that women who consumed the most DHA (an omega-3 fatty acid found in fish) had a 38 percent lower risk of developing AMD than those who consumed the lowest amount of DHA. They found similar results for EPA, another omega-3 fatty acid, as well as for consumption of both acids together.

Having one or more servings of fish per week produced a 42 percent lower risk of AMD, compared with less than one serving per month. Canned tuna and dark-meat fish were the primary types of fish that produced this lower risk.

The omega-6 fatty acids linoleic acid and arachidonic acid were also evaluated. Higher intake of linoleic acid, found in many fruit and vegetable oils such as safflower oil, grapeseed oil and corn oil, was associated with a higher risk of AMD, but not significantly so.

The study report appeared online in Archives of Ophthalmology on March 14.

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Macular Degeneration Rates Falling in the United States

MADISON, Wis., January 2011 — Sixteen years ago, an estimated 9.4 percent of U.S. adults age 40 and older had age-related macular degeneration. Now, the estimate is 6.5 percent.

How'd that happen?

The previous estimate was based on the 1988-1994 Third National Health and Nutrition Examination Survey (NHANES III), while the new one is based on data from the 2005-2008 NHANES.

In the newer study, digital photos were taken of both eyes of 7,081 people. Researchers looked for drusen, pigment changes and atrophy in the retina — all signs of age-related macular degeneration (AMD).

Other findings included a 0.8 percent prevalence of advanced AMD, plus a lower incidence of any AMD among non-Hispanic black individuals age 60 and older than among non-Hispanic white individuals of that age.

The researchers speculated that improvements in diet, physical activity and blood pressure, as well as less prevalence of smoking, may account for the change.

The report, prepared by researchers at the University of Wisconsin School of Medicine and Public Health, appeared in the January issue of Archives of Ophthalmology.

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Effectiveness Similar in Avastin-vs.-Lucentis Study

BOSTON, October 2010 — A small study of 22 patients has failed to show a difference between Avastin and Lucentis in effectiveness against the wet form of age-related macular degeneration (AMD).

The comparison of the two drugs, both produced by Genentech, was a prospective, double-masked, randomized clinical trial that took place over the course of a year. Avastin is FDA-approved for treatment of colorectal cancer, while Lucentis is approved for AMD. However, Lucentis costs about $2,000 per injection, while Avastin costs about $50.

Another difference between the two drugs as used in the study was that the Avastin patients had an average of eight injections during the year, while those in the Lucentis group had an average of four.

The study, conducted by researchers from Boston University School of Medicine and the Veterans Affairs Boston Healthcare System, appeared online in October in the journal Eye. You can read more about Lucentis and Avastin here.

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Vision-Improving Mini-Telescope Implant Now Available
for End-Stage AMD Patients

SARATOGA, Calif., August 2010 — The FDA has approved the Implantable Miniature Telescope (IMT) for people aged 75 or older with end-stage, age-related macular degeneration (AMD), which causes severe vision loss. Recipients should have stable but severe visual impairment (best-corrected distance acuity of 20/160 to 20/800).

The tiny device is placed inside one eye to improve central visual function, while the non-operated eye continues to provide peripheral vision, for mobility and orientation.

The IMT magnifies what a person views and displays the images over a wide area of the retina, to reduce the effect of the blind spot that end-stage AMD causes.

During the clinical trials, some patients could even recognize people and facial expressions after implantation of the telescope.

One of the clinical trials also showed that patients with the IMT had achieved meaningful gains in visual acuity and quality of life.

The developer of the IMT, VisionCare Ophthalmic Technologies, Inc., has created a new care program for end-stage AMD patients, called CentraSight. The program includes implantation of the IMT as an outpatient procedure, plus patient management and access to reimbursement resources.

The company is applying for a Medicare code so that more people with AMD can afford the implant.

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Asians May Be More Susceptible to Macular
Degeneration Than Before

SINGAPORE, June 2010 — Researchers at Singapore Eye Research Institute have found that, contrary to previous findings, Asians may be just as likely to develop age-related macular degeneration (AMD) as Caucasians.

The researchers analyzed results of nine studies of populations in Japan, China, South Korea, India and Singapore and found that of people aged 40 to 79, 6.8 percent had early-stage AMD and .56 percent had late-stage, vs. 8.8 percent and .59 percent of Caucasians.

The wet form of AMD was more prevalent in Asians with late-stage AMD than in Caucasians with late-stage. Asian men were more at risk for late AMD than Caucasian men and much more likely than Asian women to develop a late-stage form.

Lead researcher Tien Yi Won, MD, MPH, PhD, said that further studies would need to determine whether there is such a thing as "Asian" forms of AMD. He added that many Asian men smoke, but the analysis could not include an adjustment for this known AMD risk factor.

A report on the study appeared in the May issue of Ophthalmology.

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Macular Degeneration Film Contest Winners Announced

TORONTO, April 2010 — AMD Alliance International has announced the winners of its first film contest.

The contest encouraged submissions that would effectively explain what age-related macular degeneration is, as well as AMD Alliance's mission to spread the word about it and improve the quality of life for AMD sufferers.

First prize went to Adam Mosher, a college student whose animated video "Eyes" explains risk factors for the disease that everyone should be aware of, including smoking, a sedentary lifestyle and a bad diet.

Second and third prizes went to "What You Should Know About AMD" and "The Blue Haired Girls."

Tied for third prize was "Don't Take Vision for Granted," produced by Jennifer Hoge, which includes explanations of the disease by Michael A. Samuel, MD, an ophthalmologist at Retina Institute of California.

Jennifer's video is included here, by permission.

Please click here to view the video.

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Implant in Development to Restore Vision

CAMBRIDGE, Mass., CLEVELAND, Ohio, & IRVINE, Calif., March 2010 — Researchers have teamed up to create an implant that may help restore vision for people with macular degeneration and other diseases that damage the eye.

The implant contains enzymes that clear disease-related scar tissue. Then, progenitor cells are delivered to grow into new photoreceptors, which replace the light-sensitive cells in the retina damaged by the disease.

The research team from Harvard University, University of California, Irvine, and Case Western Reserve University have found promising results thus far. The implanted progenitor cells took the form of mature photoreceptors in a mouse model after 14 days.

"No one knows what the magic number of cells needed to regain sight is," stated Budd Tucker, PhD, one of the Harvard University researchers. However, he said previous work leads him to suspect that it's a reasonable number.

Now the team is developing a smaller implant that is more biocompatible and will cause less irritation to the eye. Team members said they will soon test the new implant on a diseased eye.

The study was reported in the January issue of Biomaterials.

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FDA Approves ForeseeHome Age-Related Macular Degeneration Monitor

ST. LOUIS, February 2010 — The ForeseeHome monitor is a tool for people with age-related macular degeneration (AMD) to detect visual distortions they may be experiencing and to monitor their progress with the disease. (See October 2009 item for more information.)

The device was in development for a time, and now the FDA has approved it for sale in the United States, for monitoring the wet form of AMD. The device, distributed by Notal Vision, can also transfer data to the patient's eye doctor, as well as the Notal Vision Data Monitoring Center.

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Smoking Increases Macular Degeneration Risk More as You Age, So It's Never Too Late To Benefit From Quitting

LOS ANGELES, February 2010 — It is becoming common knowledge that smoking increases your risk for age-related macular degeneration (AMD), possibly by reducing serum antioxidant levels and changing blood flow to the eyes. But some older people may be reluctant to stop smoking, believing that it's too late to benefit from the effects of quitting.

A UCLA study of 1,958 older women found that even after age 80, smoking continues to increase the risk for AMD. The women who smoked had 11 percent higher rates of AMD than other women their same age. But of the women who were over 80, the smokers were 5.5 times more likely to develop AMD than the non-smokers their same age.

The researchers concluded that quitting smoking even late in life may reduce your risk of developing AMD.

The study report appeared in the January issue of the American Journal of Ophthalmology.

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CATT Comparison of Avastin and Lucentis Begins

KOLOA, Hawaii, February 2010 — A major clinical trial to compare Avastin and Lucentis has completed patient enrollment, and the first results are expected in January 2011.

The study will compare the effectiveness of the two similar substances in treating age-related macular degeneration (AMD).

Many ophthalmologists have been using Avastin off label to treat their AMD patients because it is less expensive than Lucentis. However, only Lucentis is FDA-approved specifically for such eye applications, while Avastin is approved for treatment of colon and other cancers.

The study, called "Comparisons of Age-Related Macular Degeneration Treatments Trials" or CATT, will also compare fixed vs. variable dosing, to determine the best treatment strategies for certain patients at certain times.

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Low-Dose Aspirin = Low AMD Protection?

SAN FRANCISCO, January 2010 — Studies examined whether aspirin and statins, both treatments for cardiovascular disease (CVD), may impact the risk and progression of macular degeneration (AMD). The fact that CVD and AMD share similar risk factors may mean they can share similar treatments.

Researchers evaluated the results from the Women's Health Study, involving one group that took a low-dose aspirin (100 mg) on alternate days, and another group that took a placebo. After 10 years, the aspirin-taking group had 18 percent fewer women who developed AMD than the placebo group.

Although the researchers concluded that the study found no significant benefit from taking low-dose aspirin, they support further research to determine whether aspirin is mildly protective against AMD.

Another study called the Complications of Age-Related Macular Degeneration Prevention Trial examined the effects of statins, a class of lipid-lowering drugs, on advanced AMD patients. The study found no evidence that statins decreased the risk for advanced AMD. However, the researchers noted that factors may be concealing protective effects of statins because patients taking the drugs for CVD have a high risk for AMD also.

The studies were reported in the December issue of the journal Ophthalmology.

Please click here for more macular degeneration news from 2009.

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[Page updated November 30, 2011]