FDA approves Eylea

SILVER SPRING, Md. — After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

The FDA on Friday approved Eylea (aflibercept) to treat patients with wet age-related macular degeneration, a leading cause of vision loss and blindness. The wet form of AMD includes the growth of abnormal blood vessels, which can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs. An early symptom of wet AMD occurs when straight lines appear to be wavy, the FDA noted.

The drug was recommended for approval back in June by the Dermatologic and Ophthalmic Drugs Advisory Committee.

"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "It is a potentially blinding disease and the availability of new treatment options is important."


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