FEB 20, 2013
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced the start of a new Phase 3 trial to evaluate the efficacy and safety of Eylea (aflibercept) for diabetic macular edema. The trial is being conducted in Russia, China and other Asian countries.
Eylea was approved in the United States for the treatment of wet AMD in November 2011 and for macular edema following central retinal vein occlusion in September 2012. It's also approved for wet AMD in Europe, Australia, Japan and several other countries.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to the product in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of Eylea, except for Japan, where Regeneron will receive a royalty on net sales.
The first Phase 3 trial of Eylea, named VIVID-DME, is underway in Europe and Japan and is fully enrolled. A second study, VISTA-DME, is also fully enrolled and being conducted in the United States.
Additional Phase 3 trials of Eylea are underway for the treatment of myopic choroidal neovascularization in Asia and macular edema following branch retinal vein occlusion in United States, Canada and Japan.