Regeneron’s phase 3, 402-patient PANORAMA trial evaluating Eylea (aflibercept) in patients with moderately severe and severe nonproliferative diabetic retinopathy (NPDR) met its 52-week primary endpoint and key secondary endpoints, the company announced. The new data will be added to previously released 24-week findings and used to buttress Regeneron’s application for approval of Eylea for NPDR, currently under review by the FDA.
On the primary endpoint at 1 year, 80% and 65% of patients receiving Eylea on an every 8- and every 16-week interval (after an initial monthly dosing period), respectively, experienced a 2-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection. The 2 key secondary endpoints, which were reported for the first time and indicate the need for early intervention, achieved statistical significance based on the prespecified hierarchical analysis. Treatment with Eylea reduced vision-threatening complications (VTCs) by 82% to 85% and the development of center-involved diabetic macular edema (CI-DME) by 68% to 74% compared with sham injection.
The development of VTCs (proliferative diabetic retinopathy and anterior segment neovascularization) was 3% for the Eylea every 8-week group, 4% for the Eylea every 16-week group, and 20% for the sham injection group. CI-DME occurred in 8% of the Eylea every 8-week group, 7% of the Eylea every 16-week group, and 26% of the sham injection group. These events collectively occurred in 11% and 10% of patients receiving Eylea every 8 weeks or every 16 weeks, respectively, compared to 41% of patients receiving sham injection.
"Blindness caused by diabetes is one of the most feared consequences of this disease," said George D. Yancopoulos, MD, PhD, president and chief scientific Officer of Regeneron, in a news release. "In this trial of patients with diabetic eye disease and normal vision, it is notable that without treatment more than one third of patients developed a vision-threatening complication or diabetic macular edema within 1 year. Eylea was able to reduce these complications by 68% to 85% even with every 4-month dosing, and moreover was able to reverse the anatomic severity of the disease. These results point to the potential value of earlier intervention in diabetic retinopathy and may in the future change the way retina specialists treat this disease."
The average number of injections in the first year was 8.6 (of 9 planned) for the Eylea every 8-week group and 5.5 (of 6 planned) for the Eylea every 16-week group. Adverse events were consistent with the known profile of Eylea.