Regeneron presents positive detailed 1-year results from Phase 3 PANORAMA trial
Regeneron Pharmaceuticals announced that positive detailed one-year results from the Phase 3 PANORAMA trial evaluating EYLEA Injection in patients with moderately severe to severe non-proliferative diabetic retinopathy were presented for the first time at the Angiogenesis, Exudation, and Degeneration 2019 symposium. The trial confirmed that moderately severe and severe non-proliferative diabetic retinopathy is not a benign condition, with patients at high risk of rapidly progressing to vision-threatening events. In untreated patients with severe NPDR, 53% developed these events at one year. Most importantly, EYLEA treatment prevented approximately 74% of these complications. Topline one-year results from PANORAMA were previously reported in October 2018. Adverse events were consistent with the known profile of EYLEA. A supplemental Biologics License Application for EYLEA in diabetic retinopathy has been accepted for review by the FDA with a target action date of May 13, 2019. The safety and efficacy of EYLEA in diabetic retinopathy in patients without DME have not been fully evaluated by any regulatory authority.