Regeneron Pharmaceuticals Inc. (REGN) said that the Phase 3 PANORAMA trial evaluating Eylea (aflibercept) Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year primary endpoint and key secondary endpoints.
According to the company, Eylea injection improved diabetic retinopathy and reduced vision-threatening complications in the Phase 3 trial.
On the primary endpoint at one year, 80 percent and 65 percent 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 percent of patients receiving sham injection.
Regarding the two key secondary endpoints, which achieved statistical significance based on the pre-specified hierarchical analysis, Regeneron noted that treatment with Eylea also reduced vision-threatening complications or VTCs by 82 percent to 85 percent, and the development of center-involved diabetic macular edema (CI-DME) by 68 percent to 74 percent compared with sham injection.
PANORAMA is an ongoing, pivotal, double-masked, randomized, two-year trial that enrolled 402 patients and is designed to investigate Eylea for the improvement of moderately severe to severe NPDR in patients without DME, compared to sham injections.
In addition, Regeneron said that the FDA issued a complete response letter or CRL regarding the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement or PAS for the Eylea pre-filled syringe.
The CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients.
Regeneron said it expects to compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the Eylea pre-filled syringe.
