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FDA grants priority review to Eylea for diabetic retinopathy in patients with DME

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The U.S. Food and Drug Administration has granted priority review for Eylea injection for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a Regeneron press release.

In September, the U.S. Food and Drug Administration gave Eylea (aflibercept) intravitreal injection breakthrough therapy designation for the same indication.

Data from the phase 3 VIVID-DME and VISTA-DME trials supported the approval of aflibercept for treatment of DME and included a prespecified secondary endpoint that evaluated diabetic retinopathy based on an established grading scale in patients with DME, according to the release.

The Prescription Drug User Fee Act target action date is March 30, 2015.