The Phase 3 PANORAMA trial evaluating aflibercept injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints, the drug’s manufacturer announced today. Regeneron Pharmaceuticals is marketing the drug as EYELA.
On the primary endpoint at one year, 80% and 65% of patients receiving aflibercept on an every eight- and every 16-week interval (after an initial monthly dosing period), respectively, experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection (p<0.0001). Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, treatment with aflibercept also reduced vision-threatening complications (VTCs) by 82%-85% and the development of center-involved diabetic macular edema (CI-DME) by 68%-74% compared with sham injection.
- The development of VTCs (proliferative diabetic retinopathy and anterior segment neovascularization) was 3% for the aflibercept every eight-week group, 4% for the aflibercept every 16-week group, and 20% for the sham injection group (p<0.001).
- CI-DME occurred in 8% of the aflibercept every eight-week group, 7% of the aflibercept every 16-week group, and 26% of the sham injection group (p<0.001).
- These events collectively occurred in 11% and 10% of patients receiving aflibercept every eight weeks or every 16 weeks, respectively, compared to 41% of patients receiving sham injection (p<0.001).
“Blindness caused by diabetes is one of the most feared consequences of this disease,” says George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron. “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 one year. EYLEA was able to reduce these complications by 68%-85% even with every four-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 aflibercept every eight-week group and 5.5 (of 6 planned) for the EYLEA every 16-week group.
Adverse events were consistent with the known profile of aflibercept. Serious ocular treatment-emergent adverse events in the study eye occurred in 0 and 1 patients in the aflibercept treatment groups and 1 patient in the sham injection group. Ocular inflammation occurred in 1 patient in each aflibercept 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 aflibercept treatment groups and 5 patients in the sham injection group.
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