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Eylea earns breakthrough therapy designation from FDA
The U.S. Food and Drug Administration has granted breakthrough therapy designation to Eylea for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a press release from Regeneron Pharmaceuticals.The designation is based on results of the phase 3 VIVID-DME and VISTA-DME clincial trials, which showed that Eylea (aflibercept) yielded a significant improvement on disease severity scores in patients with diabetic macular edema, according to the release.