Macular Degeneration News

BOSTON, April 2008 — Declining levels of the hormone estrogen may contribute to development of advanced forms of age-related macular degeneration (AMD) in postmenopausal women, according to researchers at Brigham and Women's Hospital and Harvard Medical School.

A study found a 48 percent lower risk of developing advanced forms of macular degeneration among post-menopausal women who took estrogen as part of hormone replacement therapy. The risk was even lower for postmenopausal women who previously had taken oral contraceptives.

But in what researchers said was an unexpected finding, the risk of developing early forms of macular degeneration was 34 percent higher in women who, at the time of the study, used hormone replacement therapy. Women who had given birth had a 26 percent lower risk of developing early AMD. Past oral contraceptive use in this group was not a factor.

The study involved about 75,000 postmenopausal women who participated in the Nurses' Health Study. Between 1980 and 2002, 554 of the women developed early-stage macular degeneration, and 334 had late-stage AMD, which can cause loss of central vision.

Study results were published In the April issue of Archives of Ophthalmology.

MONTREAL, February 2008 — Researchers in Montreal have identified an underlying cause of the "dry" form of age-related macular degeneration (AMD), a discovery that could lead to development of new therapies.

Sainte-Justine Hospital and Universite de Montreal scientists said they now have a better understanding of processes that cause accumulations of lipids (fats) in the inner back of the eye (retina), which can lead to eye damage associated with macular degeneration.

"This discovery brings us one step closer to treating dry AMD, which could significantly improve the quality of life of seniors who are most affected by this eye disease," said Universite de Montreal professor and study co-author Huy Ong, PhD.

Study results were published in the February issue of the medical journal PLoS Medicine.

BALTIMORE, February 2008 — African Americans may have less risk of developing advanced macular degeneration (AMD) than Caucasians, according to recent findings by Johns Hopkins School of Medicine scientists.

Early signs of AMD include formation of yellowish spots (drusen) in the inner back of the eye (retina), where vision processing occurs. In a study involving 2,520 participants of average ages of 73.5 years, researchers found that larger drusen and those closer to the eye's center were more likely to occur in Caucasians than in African Americans.

Study authors concluded that more Caucasians than African Americans were likely to develop advanced and potentially blinding forms of macular degeneration. Researchers said more research is needed to determine why African Americans are less likely to have significant degenerative changes associated with AMD, such as those that occur in central portions of the retina.

BEAVER DAM, Wis., January 2008 — Smoking boosts risks of developing age-related macular degeneration (AMD) by nearly 50 percent, reveals a recent analysis of about 3,500 Beaver Dam, Wis. residents undergoing eye-related studies since 1987. The finding was reported in the January issue of Archives of Ophthalmology.

Study results also show that, of people who have macular degeneration, smokers on average were more likely to develop the eye disease at a younger age:

• Current smokers (69.2 years)
• Former smokers (72.3 years)
• Non-smokers who have never smoked (74.4 years)

Researchers noted that it's difficult in modern times to assess eye damage caused by secondary exposure to smoke, partly because of new laws that now restrict smoking in public areas.

LONDON, January 2008 — A British health advisory agency has reversed an earlier cost-saving proposal that allows government reimbursement for Lucentis treatments only for the second eye of individuals diagnosed with advanced or "wet" age-related macular degeneration (AMD), which can cause blindness.

The National Institute for Health and Clinical Excellence (NICE) has issued a revised proposal, with "draft" status ending Jan. 14, which would allow Lucentis to be injected in any affected eye of British citizens when treatments are capped at 14 per eye.

If additional treatments are needed, NICE officials say the Lucentis manufacturer (Genentech, San Francisco) has agreed to provide additional doses at no cost.

NICE officials say Lucentis is an effective though expensive drug capable of stabilizing vision loss in most people with advanced AMD. About 25 percent of affected eyes achieve vision improvement after regular Lucentis treatments, which cost more than $2,000 per dose.

In another recent development, Genentech announced that a much cheaper version of Lucentis, known as Avastin, will be sold directly to any physicians who choose to use the drug off-label for treating AMD. Avastin is not FDA-approved as an AMD treatment.

Late last year, Genentech made the controversial decision to cease selling Avastin directly to compounding pharmacies that had been repackaging the cancer drug for use as an AMD treatment.

In its recent announcement, Genentech said physicians choosing to use Avastin as an AMD treatment can purchase the drug directly and designate where they want it shipped — including to compounding pharmacies.

[Read more about the Avastin vs. Lucentis debate.]

BETHESDA, Md., December 2007 — An experimental drug known as endostatin shows promise as a new type of treatment for advanced age-related macular degeneration (AMD), according to a report published in the December issue of Federation of American Societies for Experimental Biology (FASEB) Journal.

Harvard and Japanese researchers used mice to test the naturally occurring substance, endostatin, which demonstrated ability to reduce or eliminate abnormal blood vessel growth in AMD that can cause sight-threatening damage in the inner back of the eye (retina).

"With Baby Boomers reaching advanced ages, new treatments are desperately needed to keep age-related macular degeneration from becoming a national epidemic," said Gerald Weissmann, MD, editor-in-chief of The FASEB Journal.

Endostatin is a protein found in collagen and currently also is being tested as a potential cancer treatment.

SAN FRANCISCO, October 2007 — American Academy of Ophthalmology (AAO) representatives say people with the advanced, "wet" form of macular degeneration could be denied access to a cheap, effective form of treatment, based on a recent decision by Genentech to reduce availability of Avastin.

Genentech, which markets Avastin, recently sent a letter to retinal specialists that says eye doctors should prescribe the U.S. Food and Drug Administration-approved version of the drug, known as Lucentis, because it is formulated specifically for treating advanced, age-related macular degeneration (AMD).

Avastin, a form of Lucentis, is a much cheaper cancer drug that many eye doctors are using off-label. The drug is obtained from "compounding pharmacies" that divide Avastin into smaller quantities necessary for injecting into the eye to treat AMD.

Genentech originally notified retinal specialists that Avastin as of the end of November would no longer be sold to compounding pharmacies, which likely will cut off supplies of the drug for ocular uses. The deadline later was extended to Jan. 1. Company officials said Avastin will be distributed as usual directly to other pharmacies and physicians for its approved use as a drug for colon and other types of cancer.

Genentech officials said FDA inspectors have expressed concern about the unapproved ocular use of Avastin and issues of sterility involving how the drug is repackaged at compounding pharmacies.

Genentech in the letter to retinal specialists says the company has programs for working with individuals who might have economic difficulty while undergoing the more expensive Lucentis treatments.

But the AAO says Genentech's decision may adversely affect those with macular degeneration who can't afford Lucentis and now also denies use of Avastin for off label treatment of diabetic retinopathy and other sight-threatening diseases.

"Our main concern is for our patients with macular degeneration, who have come to rely on Avastin in their fight against potential vision loss," said AAO President Charles "Pat" Wilkinson, MD. "Together with the retinal community, the Academy is evaluating how this decision will affect patient care."

[Read more about the Avastin-Lucentis debate.]

ROCKVILLE, Md., September 2007 —Yellow plant pigments commonly found in yellow and dark green, leafy vegetables may reduce the risk of macular degeneration (AMD), according to a study reported in the September issue of Archives of Ophthalmology.

Researchers said the two pigments (carotenoids), lutein and zeaxanthin, appear to filter short-wavelength light that can damage the eye's retina, where images are processed.

Specific effects of lutein and zeaxanthin were evaluated from results of the major Age-Related Eye Disease Study (AREDS) based in Rockville, Md. from 1992 through 1998. About 4,500 individuals were involved in the National Eye Institute study.

TARRYTOWN, N.Y. & LEVERKUSEN, Germany, August 2007 — Regeneron and Bayer HealthCare have entered late stage U.S. Food and Drug Administration clinical trials for the VEGF Trap-Eye, a potential treatment for advanced, "wet" forms of macular degeneration (AMD).

"While this trial enables us to continue in our effort to improve the lives of patients suffering from wet AMD, it also signals the beginning of a larger, more global development program investigating the potential of VEGF Trap-Eye for the treatment of diabetic eye diseases and other eye diseases and disorders," said Avner Ingerman, MD, Regeneron vice president and ophthalmology team leader.

The phase 3 study will compare effectiveness of VEGF Trap-Eye with Lucentis (Genentech), which received FDA approval as a treatment for "wet" macular degeneration in 2006. Like Lucentis, VEGF Trap-Eye is injected into the eye to reduce or prevent abnormal blood vessel growth in the retina — a condition that occurs with advanced forms of AMD.

Company officials say early studies indicate VEGF Trap-Eye may be effective at lower dosing frequencies. About 1,200 individuals with AMD will be enrolled in the study at more than 200 centers in the United States and Canada.

BOSTON, July 2007 — Consuming too many "bad" carbohydrates may significantly increase your chance of developing advanced age-related macular degeneration (AMD), according to study results reported in the July issue of the American Journal of Clinical Nutrition.

Low glycemic or "good" carbohydrates are found in foods containing whole grain, whereas high glycemic or "bad" carbohydrates are found in processed foods such as white rice.

Researchers say evidence is building that "bad" carbs rating high on a glycemic index can cause spikes in blood sugar that are unhealthy for eyes, whereas "good" carbs help stabilize blood sugar.

"Men and women who consumed diets with a higher glycemic index than average for their gender and age group were at greater risk of developing advanced AMD," corresponding study author Allen Taylor, PhD, of Tufts University said. "The severity of AMD increased with increasing dietary glycemic index."

Boston researchers in 2006 announced preliminary findings showing a link between "bad" carbs and development of advanced macular degeneration. For the current study, researchers analyzed detailed dietary information involving about 4,000 people who had participated in the major Age-Related Eye Disease Study (AREDS), sponsored by the National Eye Institute.

[Read more about vision and nutrition.]

LONDON, July 2007 — Medical doctors are challenging a recommendation by British officials that says macular degeneration treatments Lucentis (ranibizumab) and Macugen (pegaptanib) should be withheld until one eye is blinded.

Under guidelines proposed by the British National Institute for Health and Clinical Excellence (NICE), only the better eye could be treated as a cost savings measure.

But to consider restricting macular degeneration treatments until one eye is blinded is "unacceptable," says the July issue of the Drug and Therapeutics Bulletin (DTB), published by the British Medical Association.

"Pegaptanib and ranibizumab need to be made available for use throughout the NHS [British National Health Service], as is the case in Scotland," the bulletin says. "In the absence of such national arrangements elsewhere in the UK, NHS commissioners need to work with local clinicians to ensure that the benefits of these drugs are made available to as many patients as possible."

[Read more about approved and investigational macular degeneration treatments.]

NEW YORK CITY, June 2007 — Researchers say Avastin (bevacizumab), a cancer drug widely used off-label for treating macular degeneration, has been shown to help offset adverse effects of radiation treatment in individuals threatened with blindness as a side effect.

In study results published in the June issue of Archives of Ophthalmology, New York Eye and Ear Infirmary investigators said Avastin (Genentech, San Francisco) demonstrated ability to maintain or improve vision in cancer patients with radiation retinopathy, which damages the eye's light-sensitive retina.

Investigators said more studies are needed to test Avastin's effectiveness as a treatment for radiation retinopathy. Avastin helps stop abnormal blood vessel growth in the eye's retina, which occurs both with macular degeneration and radiation retinopathy.
 

SOUTHAMPTON, U.K., May 2007 — British researchers have found that Lucentis (ranibizumab) costs about 50 times more than a similar drug, Avastin (bevacizumab), for treating macular degeneration. But Lucentis does not appear to be at least 2.5 times more effective, which researchers say would justify the difference in cost.

Both drugs are marketed by Genentech (San Francisco), which created Lucentis as a form of its cancer drug, Avastin. Lucentis also has undergone extensive clinical trials specifically as a treatment for macular degeneration.

A controversy now exists over the preference some eye doctors now have for using Avastin as an off-label treatment for age related macular degeneration.

"Ranibizumab [Lucentis] is highly unlikely to be a cost-effective alternative to bevacizumab [Avastin]," researchers concluded in study results published in the May issue of British Journal of Ophthalmology.

[Read more about approved and investigational macular degeneration treatments.]

BOSTON, March 2007 — A 12-year study has shown that taking beta-carotene supplements alone appears unlikely to prevent macular degeneration, according to the March issue of Archives of Ophthalmology.

The large-scale study conducted by various Harvard institutions, affiliates and other participating sites involved 22,071 male U.S. physicians who were given 50 mg. of beta-carotene supplements or a placebo every other day.

Age-related macular degeneration is a common eye disease causing central vision loss and potential blindness.

WALTHAM, Mass., February 2007 — OXiGENE has reported early positive results from clinical trials involving an experimental drug for myopic macular degeneration, known as Combretastatin A4 Phosphate (CA4P).

Myopic macular degeneration can occur in younger people when they have certain inherited conditions or diseases leading to focusing problems, along with abnormal formation of blood vessels in the inner back of the eye (retina). Central vision loss also can occur, as it does with the age-related form of macular degeneration.

While complete study results will not be released until May 2007, early findings indicate that all patients with myopic macular degeneration who received injections of Combretastatin through a vein experienced no further vision loss.

Company officials say they have met with the U.S. Food and Drug Administration regarding future investigations of Combretastatin as a topical treatment (eye drops, etc.), which also might address age-related macular degeneration (AMD).

BRISTOL, England, February 2007 — A British survey conducted in different regions of the United Kingdom reveals that teens fear blindness even more than smoking-related diseases of cancer and heart disease. Yet, few teenagers are aware that smoking can cause potentially blinding eye diseases such as macular degeneration.

"There is a lack of awareness in general of this link between smoking and eye diseases," researchers wrote in the online edition of British Journal of Ophthalmology, published in February 2007.

While most teenagers surveyed knew that smoking can cause lung cancer, only 5 percent were aware that smoking also can cause blindness.

Yet, study authors noted survey results showing that fear of blindness was more of a motivating factor for teens to quit smoking than fear of lung cancer, heart disease or deafness.

Researchers found that, among 260 British teens between ages of 16 and 18 who were surveyed, young women were more likely to smoke daily (21 percent) compared with young men (15 percent).

BOSTON, January 2007 — A retrospective study of 457 participating health care professionals has shown that individuals with certain common genetic mutations are 50 times more likely to develop age-related macular degeneration than people who have normal copies of the same genes.

The chance of developing macular degeneration, which can cause central vision loss, incrementally increased when lifestyle-related factors of smoking and obesity were added into the genetic equation. Researchers noted that genetic mutations associated with macular degeneration are common in Caucasian populations.

In the study, genetic risk factors were not affected in either a negative or positive way by other lifestyle choices including regular aspirin use, fruit consumption, fatty acid ratios or use of alcohol.

Results of the study, conducted by Brigham and Women's Hospital and Harvard Medical School, were published in the January 2007 issue of Archives of Ophthalmology.

PLYMOUTH MEETING, Pa., January 2007 — Genaera Corp. has announced that clinical studies of the experimental drug, Evizon, for macular degeneration have been discontinued because the therapy is unlikely to be as effective as currently available treatments including Lucentis and Avastin.

Evizon (squalamine lactate) is derived from dog fish sharks and works by helping to disrupt processes that cause abnormal blood vessel growth associated with vision loss in advanced macular degeneration.

"Preliminary information from investigators...suggests that Evizon is unlikely to produce vision improvement with the speed or frequency necessary to compete with recently introduced treatments," Genaera Corp. President and CEO Jack Armstrong said in a company news release.