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FDA Approves Eylea for Eye Disorder in Older People
Date:11/18/2011

floating spots in a person's vision (vitreous floaters), clouding of the eye lens (cataract), and an increase in eye pressure.

Eylea should not be used in those who have an active eye infection or active ocular inflammation. Eylea has not been studied in pregnant women, so the treatment should be used only in pregnant women if the potential benefits of the treatment outweigh any potential risks. Age related macular degeneration does not occur in children and Eylea has not been studied in children.

Other FDA-approved treatment options for wet AMD include: Visudyne (verteporfin for injection) approved in 2000, Macugen (pegaptanib sodium injection) approved in 2004, and Lucentis (ranibizumab injection) approved in 2006.

Eylea is marketed by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.

For more information:

FDA: Spotlight on Drug Innovation – Update of FDA's novel drug approvals in 2011
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm254242.htm

NEI: Facts about Age-Related Macular Degeneration
http://www.nei.nih.gov/health/maculardegen/armd_facts.asp

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov


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SOURCE U.S. Food and Drug Administration
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