DEC 19, 2013
Regeneron Pharmaceuticals, Inc.
Comprehensive Ophthalmology, Retina/Vitreous
The FDA has accepted for standard review the supplemental Biologics License Application for Eylea (aflibercept) injection for diabetic macular edema (DME).
The target action date for the submission is Aug. 18, 2014. This Eylea submission is based on the results from the phase 3, double-masked VIVID and VISTA trials for DME.
Eylea was approved for the treatment of wet AMD in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012.