FDA Approves Macular Degeneration Drug EYLEA

Available for Comment: American Health Assistance Experts and People Living with Macular Degeneration

CLARKSBURG, MD-The U.S. Food and Drug Administration (FDA) on November 18 approved the new drug application for aflibercept ophthalmic solution (trade name EYLEA), a new product for treatment of wet age-related macular degeneration (wet AMD). The action follows the unanimous recommendation of the drug’s approval, issued last June by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Already affecting 11 million Americans, AMD is likely to affect an increasing number of people as the Baby Boom generation ages. With AMD, patients lose their central or “straight-ahead” vision, which interferes with activities like reading, writing, driving, and recognizing faces.

Also known as VEGF Trap-Eye, Eylea was developed for the treatment of the neovascular form of age-related macular degeneration. It would be given as an eye injection in dosage of 2 milligrams every eight weeks, following three initial doses given every four weeks. This may result in fewer doctor visits, and perhaps greater drug adherence, compared to the limited number of products on the market currently.

Experts Available for Comment

Drs. Guy Eakin and Diane Bovenkamp of the American Health Assistance Foundation are available for background information, comments, or interviews-to explain the disease, relay concerns of families affected by AMD, and summarize why a new treatment option is a major development. Dr. Eakin’s comments at the June FDA hearing are available online.

AHAF does not endorse any particular product and has no financial relationship to any manufacturers of existing or proposed AMD treatments.

Living with AMD: Artists and Writers Share Their Stories

Available for interviews, three women with special talents try not to let AMD stop their creativity, even as they make changes imposed by the disease. Gloria Smith of California, an 86-year old visual artist, was devastated when diagnosed with macular degeneration at age 65. Yet she continues to paint and to win awards, after changing her style from realistic landscapes to abstract art. Washington, DC artist Marion Reh Gurfein took control by trying a new form of art for her, using scissors and beautiful colored paper. Virginia writer Jean Payne Harper keeps her sense of humor, noting, “While this ailment robs me of what I consider important parts of living, it also supplies some funny and embarrassing moments and makes me learn compensating ways to make life a little more worth living.” She continues to write using computer systems geared to the sight-impaired and other supports.