Aflibercept filed in Japan

Tarrytown, NY, and Berlin, Germany-Regeneron Pharmaceuticals Inc. and Bayer HealthCare have announced that Bayer Yakuhin Ltd., Osaka, Japan, has submitted an application to Japan’s Ministry of Health, Labor, and Welfare (MHLW) for marketing authorization of aflibercept ophthalmic solution (VEGF Trap-Eye) for the treatment of the neovascular form of age-related macular degeneration (AMD).

The submission to MHLW is based on the positive results from two phase III trials:  the VIEW 1 study conducted in North America, and the VIEW 2 study conducted in Japan, Europe, and other countries.
Aflibercept was submitted for marketing approval for the treatment of wet AMD in the United States in February 2011 by Regeneron, and in Europe in June 2011 by Bayer HealthCare.

Regeneron and Bayer HealthCare are collaborating on the global development of aflibercept for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. Bayer HealthCare will market aflibercept outside the United States, while Regeneron maintains exclusive marketing rights in the United States.