Posted by Michael Wonder on 13 Sep 2018
FDA to review Eylea (aflibercept) injection for the treatment of diabetic retinopathy
13 September 2018 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental biologics license application of Eylea (aflibercept) Injection for the treatment of diabetic retinopathy, the leading cause of vision loss for patients with diabetes.
The target action date for the FDA decision is 13 May 2019.
The submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular oedema. Positive six-month top-line results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.
