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Eylea approved in European Union for treatment of DME

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Regeneron Pharmaceuticals has received approval from the European Commission for Eylea in the treatment of visual impairment from diabetic macular edema, the company announced.

Bayer Healthcare plans to launch Eylea (aflibercept) for DME in the European Union in the third quarter of 2014, according to a company news release.

The U.S. Food and Drug Administration approved aflibercept for age-related macular degeneration in 2011, macular edema resulting from central retinal vein occlusion (CRVO) in 2013 and for DME in July 2014.

Aflibercept is approved in the E.U. and other regions for wet AMD and macular edema following CRVO.

Regeneron has submitted aflibercept for regulatory review in Japan, the Asia-Pacific region and Latin America for the treatment of DME. The company has also submitted the agent in Japan for review in the treatment of choroidal neovascularization following pathologic myopia.

Aflibercept is currently under regulatory review in the U.S. and E.U. for the treatment of macular edema following branch retinal vein occlusion, according to the release.