Drug news
FDA grants Breakthrough Designation to Eylea for treatment of Diabetic Retinopathy -Regeneron + Bayer
Regeneron Pharmaceuticals, Inc. announced that the FDA has granted Eylea (aflibercept) Injection Breakthrough Therapy designation for the treatment of Diabetic Retinopathy in patients with Diabetic Macular Edema (DME). The designation is based on positive results in two Phase III trials (VIVID-DME and VISTA-DME), in which Eylea demonstrated a statistically significant improvement in a pre-specified measure of Diabetic Retinopathy in patients with DME after two years of treatment.
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