U.S. FDA Accepts Regeneron's Diabetic Retinopathy Candidate Submission For Review

The U.S. Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ REGN supplemental Biologics License Application (sBLA) of EYLEA (aflibercept) Injection for review in patients with diabetic retinopathy (DR).

The regulatory agency has set a target action date of February 28, 2023. 

The supplemental Biologics License Application (sBLA) is supported by data readout from the Phase 3 PANORAMA trial investigating every 8- and 16-week EYLEA dosing regimens, versus sham, in patients with severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME).

Additionally, the filing was further supported by clinical data from the NIH-sponsored Protocol W trial evaluating an EYLEA every 16-week dosing regimen in patients with moderate to severe NPDR without center-involved DME versus sham.

If approved by the regulators, the EYLEA every 16-week dosing regimen could offer certain patients a potentially longer treatment interval and doctors with greater flexibility to individualize treatment.

Diabetic Retinopathy (DR) is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes.

Regeneron is trading high at $598 on Wednesday during pre-market session.