FDA Extends Target Date for Review of Eye Drug

Caroline Helwick

August 17, 2011

August 17, 2011 — The US Food and Drug Administration (FDA) has pushed back its target date for completing its review of aflibercept ophthalmic solution (Eylea, Regeneron Pharmaceuticals, Inc), an injectable drug for the treatment of neovascular ("wet") age-related macular degeneration (AMD).

According to Regeneron, the agency expects to complete its review of the drug by November 18, 2011. The FDA needs more time to review recent responses as part of Regeneron's bid to obtain a license for AMD, the company indicated.

The approval had been expected imminently. On June 17, 2011, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 10 to 0 in favor of aflibercept's approval. The thumbs-up was based on the positive results from 2 phase 3 trials that found the drug noninferior to ranibizumab (Lucentis, Genentech), considered to be the most potent drug currently approved for the condition.

The committee's recommendation for approval is not binding on the FDA, but the agency usually follows the recommendations of its advisory committees.

Regeneron and Bayer HealthCare are collaborating on the global development of aflibercept for wet AMD, central retinal vein occlusion, diabetic macular edema, and other eye diseases and disorders. Bayer has submitted an application for marketing authorization of the drug in Europe.


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