Eylea meets 52-week endpoint in Phase III for diabetic retinopathy subset
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said both dosing schedules of Eylea aflibercept met the 52-week primary endpoint in the Phase III PANORAMA trial for early intervention of non-proliferative diabetic retinopathy without diabetic macular edema (DME). The company reported in March that Eylea met the first, 24-week primary endpoint in the trial. An sBLA to add the indication to Eylea’s label based on the 24-week data is under FDA review with a May 13, 2019 PDUFA date (see "Regeneron's Eylea Clears First Phase III Hurdle in Diabetic Retinopathy Subset”).
Regeneron also said it received a complete response letter from FDA for a prefilled syringe of Eylea requesting additional manufacturing information and completion of a usability study in 30 patients. The company still expects to launch the prefilled syringe in 2019...