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

BrightFocus Offers Information on the Disease and Patients’ Urgent Need for More Treatments

August 17, 2011

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).  Already affecting 11 million Americans, 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 BrightFocus 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. 

Detailed information on AMD is available at www.brightfocus.org/macular

View all news updates for macular degeneration

Disclaimer: The information provided in this section is a public service of the BrightFocus Foundation, and should not in any way substitute for the advice of a qualified healthcare professional, and is not intended to constitute medical advice. Although we take efforts to keep the medical information on our website updated, we cannot guarantee that the information on our website reflects the most up-to-date research. Please consult your physician for personalized medical advice; all medications and supplements should only be taken under medical supervision. BrightFocus Foundation does not endorse any medical product or therapy.

Some of the content in this section is adapted from other sources, which are clearly identified within each individual item of information.

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