Regeneron Pharmaceuticals (NASDAQ:REGN) presents positive detailed one-year results from the Phase 3 PANORAMA trial evaluating EYLEA (aflibercept) Injection in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) at the Angiogenesis, Exudation, and Degeneration 2019 symposium.
The trial confirmed that moderately severe and severe NPDR 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 reduced the risk of these events by ~74% compared to sham injection.
This efficacy was seen even with an every 16-week treatment regimen after loading doses.
Adverse events were consistent with the known profile of EYLEA.
A sBLA for EYLEA in diabetic retinopathy has been accepted for review by the FDA with a target action date of May 13, 2019.
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