FDA panel unanimously recommends approval of Eylea

TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

The FDA is not required to follow an advisory committee’s recommendation when deciding whether or not to approve a drug, but it usually does. The agency plans to make its decision on Aug. 20, according to Regeneron.

Login or Register to post a comment.