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.
Detailed information on AMD is available at www.ahaf.org/macular.
AHAF does not endorse any particular product and has no financial relationship to any manufacturers of existing or proposed AMD treatments.
Stay connected to ground-breaking research news and volunteer to be an advocate by signing up at www.ahaf.org/news. To follow the American Health Assistance Foundation on Twitter and Facebook, visit www.ahaf.org/connect. Share your stories about macular degeneration at http://www.ahaf.org/online-community-resources.html.
* Macular degeneration estimate updated June 2012
About the American Health Assistance Foundation
The American Health Assistance Foundation (www.ahaf.org) is a nonprofit organization dedicated to finding cures for age-related degenerative diseases by funding research worldwide under its three program areas: Alzheimer's Disease Research, Macular Degeneration Research, and National Glaucoma Research. AHAF also provides public information about these diseases.
Stay connected to ground-breaking research news by signing up for AHAF eAlerts at www.ahaf.org/news. To follow American Health Assistance Foundation on Twitter and Facebook, visit www.ahaf.org/connect.