Press release
Aflibercept 8 mg Two-Year Results from Pivotal PHOTON Trial in Diabetic Macular Edema Presented at ASRS
89% and 84% of patients were maintained on ≥12- and ≥16-week dosing intervals, respectively, throughout the two-year period, while sustaining their vision and
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"89% and 84% of patients were maintained on ≥12- and ≥16-week dosing intervals, respectively, throughout the two-year period, while sustaining their vision and anatomic improvements At two years, 44% of patients met the criteria for ≥20-week dosing intervals, including 27% who were eligible for 24-week dosing intervals TARRYTOWN, N.Y., July 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of positive two-year (96 weeks) results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection, in patients with diabetic macular edema (DME). The results were presented at the American Society of Retina Specialists (ASRS) annual meeting. “At two years, the PHOTON trial demonstrates the substantial impact aflibercept 8 mg could have in reducing treatment burden for patients with diabetic macular edema,” said Diana V. Do, MD, Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University and a trial investigator. “Maintaining two years of vision and anatomic improvements with as few as three or four injections per year, while not compromising safety, is impressive and could make a meaningful difference in the lives of the patients we treat.” PHOTON (N=658) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg extended dosing intervals compared to EYLEA. Patients receiving aflibercept 8 mg were initially randomized to either 12- (n=328) or 16-week (n=163) dosing intervals (after three initial monthly doses) compared to an 8-week dosing regimen for EYLEA (n=167) after five initial monthly doses. During the trial, patients receiving aflibercept 8 mg could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Patients were only able to extend their dosing intervals in the second year by 4-week increments up to 24-weeks, if pre-specified criteria were met. The PHOTON trial met its primary endpoint last year with aflibercept 8 mg patients achieving clinically equivalent vision gains to EYLEA, with approximately 90% maintaining 12- and 16-week dosing regimens through the first year. Through two years, the mean number of injectio...