Eylea recommended for approval in Europe for DME visual impairment
Aflibercept injection has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of visual impairment due to diabetic macular edema, according to a Regeneron press release.
The recommendation is based on positive data from the phase 3 VIVID-DME and VISTA-DME studies.
“Diabetes is a growing health concern worldwide, and this milestone brings us one step closer to being able to offer patients and physicians in the European Union a new therapeutic option for the treatment of diabetic macular edema,” George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the press release.
Two-year data from the VIVID-DME trial are expected later in 2014.
Aflibercept (Eylea) was approved in the United States for the treatment of wet age-related macular degeneration in November 2011 and for macular edema following central retinal vein occlusion (CRVO) in September 2012. It has also been approved in the European Union and in other countries for the treatment of wet AMD and macular edema following CRVO, according to the release.
The European Commission’s final decision is expected in the second half of 2014.