Regeneron reports Phase 3 PANORAMA trial met primary endpoint
Regeneron Pharmaceuticals announced that the Phase 3 PANORAMA trial evaluating EYLEA Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy met its one-year primary endpoint and key secondary endpoints. On the primary endpoint at one 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 two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale, compared to 15% of patients receiving sham injection. Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, treatment with EYLEA also reduced vision-threatening complications by 82%-85% and the development of center-involved diabetic macular edema by 68%-74% compared with sham injection. George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, said, "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."