Eylea (aflibercept) injection demonstrates positive topline results in Phase 3 non-proliferative diabetic retinopathy trial.
Regeneron Pharmaceuticals, Inc.’s Phase 3 PANORAMA trial evaluating Eylea (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint.
In the trial, 58 percent of Eylea-treated patients experienced a two-step or greater improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) at week 24, compared to 6 percent of patients receiving sham injection (p<0.0001).
“This is the first time a therapy has demonstrated it can reverse disease progression in patients with moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema, in a trial specifically designed to study this population,” said George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer of Regeneron. “Patients in the trial continue to be evaluated to determine if Eylea can prevent progression to neovascular vision-threatening complications or diabetic macular edema. We look forward to sharing one-year results later this year.”
Patients in the active treatment groups received, on average, 4.4 Eylea injections during the first 24 weeks. There were no new safety signals in the trial. There was one case of mild intraocular inflammation (IOI) in a patient treated with Eylea (0.085 percent rate per injection), which is consistent with the rate of IOI seen in previous clinical trials.
(Source: Regeneron Pharmaceuticals, Inc.)
Filed Under: Drug Discovery