European Commission Approves Regeneron's Diabetic Macular Edema Drug

"DME is the leading cause of vision loss in working-age adults in much of the developed world, and we believe EYLEA will be an important new treatment option for these patients," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "We are pleased that EYLEA is now approved in both the U.S. and the EU for three important ophthalmic indications." 

EYLEA was approved in the United States for the treatment of wet Age-related Macular Degeneration (AMD) in 2011, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, and for DME in July 2014. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and the EU for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO). 

Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.