FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

16 September 2014

US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) says that the US Food and Drug Administration 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. Eylea is being developed with German pharma major Bayer (BAYN: DE).

sBLA regulatory filing anticipated later this year

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