Panel recommends aflibercept for wet AMD treatment

Tarrytown, NY-Aflibercept ophthalmic solution (Eylea, Regeneron) has received a unanimous recommendation from the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA for the treatment of the neovascular (wet) form of age-related macular degeneration (AMD).

The committee's recommendation will be considered by the FDA in its review of the Biologics License Application (BLA) for aflibercept ophthalmic solution, but the committee's recommendation is not binding on the FDA. Regeneron submitted a BLA for marketing approval for aflibercept in the United States in February and received a priority review designation. Under priority review, the target date for an FDA decision on the aflibercept BLA is Aug. 20, 2011.

Aflibercept ophthalmic solution, also known as vascular endothelial growth factor (VEGF) Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related placental growth factor (PlGF). According to Regeneron, aflibercept is a specific and highly potent blocker of these growth factors. The company says its formulation is purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

The aflibercept wet AMD regulatory submissions are based on the positive results from two phase III trials, the VIEW 1 study and the VIEW 2 study.