FDA Decision on Macular Degeneration Drug (Eylea) Delayed Until November 18

American Health Assistance Offers Information on the Disease and Patients’ Urgent Need for More Treatments

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee met on June 17 to review the new drug application for aflibercept ophthalmic solution (trade name EYLEA), a new product for treatment of wet age-related macular degeneration (wet AMD). Advanced AMD already affects more than 2 million Americans, and this degenerative disorder is likely to affect an increasing number of people as the Baby Boom generation ages.*

While the committee made a unanimous recommendation to approve the drug at that meeting, the FDA announced in August that a decision regarding drug approval would be delayed until November 18.

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.

Dr. Guy Eakin of the American Health Assistance Foundation spoke at the June FDA hearing, relaying concerns of families affected by AMD and summarizing why a new treatment option is a major development. His comments are available online.