One-year results from a Phase 3 clinical trial show early intervention with Eylea (aflibercept), lessened diabetic retinopathy severity and prevented serious vision-threatening complications, according to results presented by its makers, Regeron Pharmaceuticals, in Miami, Florida.

Positive, detailed one-year results from the Phase 3 PANORAMA trial evaluating the use of injected vascular endothelial growth factor (VEGF) inhibitor Eylea 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 researchers said 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, they said, 53% developed these events at one year, while the Eylea treatment prevented approximately 74% of these complications.

Topline one-year results from PANORAMA were previously reported in October 2018.

"PANORAMA is the first prospective trial involving these high-risk patients since the landmark ETDRS trial of the 1980s when laser was the only treatment option," said retinal surgeon, Dr Charles Wykoff, who is involved in the study. "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, the study reported, with serious ocular treatment-emergent adverse events in the study eye occurring 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.

The safety and efficacy of EYLEA in diabetic retinopathy in patients without DME have not been fully evaluated by any regulatory authority, according to the media release on the results.