FDA to Review Injection Treatment for Diabetic Retinopathy – APhA submits compounding comments to FDA. – (866) 348-2889.
The FDA has accepted for review Regeneron Pharmaceuticals’ supplemental Biologics License Application (sBLA) of aflibercept (EYLEA Injection) to treat diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes.
The agency is expected to make a decision on the application in the spring.
The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe nonproliferative diabetic retinopathy without diabetic macular edema (DME), according to Regeneron.