February 03, 2015
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Eylea for macular edema secondary to CRVO, BRVO recommended for approval in EU
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The European Committee for Medicinal Products for Human Use recommended the approval of Eylea for the treatment of visual impairment due to macular edema secondary to central or branch retinal vein occlusion, according to a press release from Regeneron.
The submission is based on the previously approved indication for macular edema due to CRVO and phase 3 VIBRANT study results, the release said.
Eylea (aflibercept) is currently approved in the U.S. for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema. It is approved in Europe and other markets for wet AMD and DME, the release said.
Bayer HealthCare has marketing rights to Eylea outside the United States.