The FDA has agreed to review a supplemental biologics license application of Eylea for the treatment of diabetic retinopathy, Regeneron announced in a press release.
Data from the phase 3 PANORAMA trial found positive top-line results for Eylea (aflibercept) injection after 6 months in patients with moderately severe to severe nonproliferative diabetic retinopathy without diabetic macular edema. The sBLA submission was based on data from this trial, according to the release.
The FDA’s target action date for a decision is May 13, 2019.
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