Press release
Two-year PULSAR Trial Results for Aflibercept 8 mg Demonstrate Durable Vision Gains at Extended Dosing Intervals in Wet Age-related Macular Degeneration
88% of all aflibercept 8 mg patients were on a ≥12-week dosing interval at the end of two years 78% of all aflibercept 8 mg patients maintained ≥12-week
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"88% of all aflibercept 8 mg patients were on a ≥12-week dosing interval at the end of two years 78% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals throughout the two-year study period 71% met the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals Visual gains and safety of aflibercept 8 mg remained consistent with the established profile of EYLEA® (aflibercept) 2 mg Injection TARRYTOWN, N.Y., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive, two-year (96 weeks), topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet age-related macular degeneration (wAMD). During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met. The longer-term data follow the positive two-year results for PHOTON with diabetic macular edema (DME), with PULSAR similarly demonstrating that the vast majority of aflibercept 8 mg patients with wAMD were able to maintain or further extend their dosing intervals. Among those who completed the two-year follow-up: 88% were on a ≥12-week dosing interval at the end of two years.78% maintained ≥12-week dosing intervals throughout the two-year study period, compared to 83% throughout the first year of study (48 weeks).71% met the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals.Of those assigned to ≥16-week dosing regimen at baseline, 70% maintained ≥16-week dosing intervals throughout the two-year study period. At the end of two years, 78% were eligible for ≥16-week dosing, with 53% eligible for ≥20-dosing week intervals. “It is great to see aflibercept 8 mg deliver another set of exciting results,” said Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants of Texas and a trial investigator. “In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year one through year two. These data are consistent with the results from the PHOTON trial in diabetic macular edema, with both trials demonstrating a consiste...