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GEN News Highlights : Nov 22, 2011

FDA Okays Regeneron’s Wet AMD Therapy

Partner Bayer submitted approval application in Europe earlier this year.

Regeneron Pharmaceuticals’ Eylea™ (aflibercept; VEGF Trap-Eye) injection has been cleared by FDA for the treatment of wet age-related macular degeneration (wet-AMD). Approval was based on data from two active-control Phase III studies, View 1 and View 2, involving 2,412 patients treated either with one of three dosage regimens of Eylea, or with four weekly injections of Lucentis® (ranibizumab injection). The data confirmed the non-inferiority of Eylea therapy dosed every week, following three initial monthly injections, in terms of maintaining visual acuity over the course of a year.

“Eylea offers the potential of achieving the efficacy we’ve come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements,” comments Jeffrey Heier, M.D., assistant professor of ophthalmology at Tufts School of Medicine, and chair of the steering committee for the View 1 trial. “The approval of Eylea offers a much needed new treatment option for patients with wet AMD.”

Eylea is a recombinant fusion protein comprising protions of the human VEGF receptors 1 and 2 extracellular domains, fused to the Fc portion of human IgG1. The drug is being developed by Regeneron in collaboration with Bayer HealthCare, which in June submitted a marketing authorization to the European authorities for approval of the drug in the wet AMD indication. Under terms of the Regeneron and Bayer HealthCare collaboration, Regeneron maintains exclusive rights to Eylea in the U.S., while Bayer HealthCare will market the drug outside of the U.S., and equally share sales profits with Regeneron.