Phase III PANORAMA trial of Eylea confirms benefits in diabetic retinopathy.- Regeneron Pharma

Regeneron Pharmaceuticals announced that positive detailed one-year results from the Phase III PANORAMA trial evaluating Eylea (aflibercept) Injection in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) 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.

Without treatment, a large percentage of patients in the trial developed proliferative disease and CI-DME in the first year. Eylea treatment reduced the risk of these events by approximately 74% compared to sham injection, underscoring the potential importance of early Eylea anti-VEGF therapy. This efficacy was seen even with an every 16-week treatment regimen after loading doses, a management approach that may realistically be achieved in the real world.

Adverse events were consistent with the known profile of Eylea. Serious ocular treatment-emergent adverse events in the study eye occurred in 0 and 1 patients in the Eylea treatment groups and 1 patient in the sham injection group. Ocular inflammation occurred in 1 patient in each Eylea treatment group and 0 patients in the sham injection group. Anti-Platelet Trialists' Collaboration (APTC)-defined arterial thromboembolic treatment-emergent events occurred in 4 and 2 patients in the Eylea treatment groups and 5 patients in the sham injection group.

Comment: Topline one-year results from PANORAMA were previously reported in October 2018. A supplemental Biologics License Application (sBLA) for Eylea in diabetic retinopathy has been accepted for review by the U.S. FDA with a target action date of May 13, 2019.