Regeneron, Bayer Initiate Phase 3 Trial of EYLEA Injection for Treatment of Diabetic Macular Edema in Asia and Russia

Regeneron Pharmaceuticals, Inc.

and Bayer HealthCare today announced that they have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries.  The companies are extending their global development program for EYLEA in DME after promising results in the global Phase 2 DME program. "DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development.  "With this new trial, we look forward to potentially bringing another treatment option to patients with DME in Asia and Russia." EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012.  In Japan EYLEA was approved for use in wet AMD in September 2012.  EYLEA was