Regeneron announces PULSAR trial met its primary endpoint

Regeneron Pharmaceuticals announced positive, two-year, 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 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 greater than or equal to12-week dosing interval at the end of two years. 78% maintained greater than or equal to12-week dosing intervals throughout the two-year study period, compared to 83% throughout the first year of study. 71% met the extension criteria for even longer dosing intervals, including 47% for greater than or equal to20-week intervals and 28% for 24-week intervals. Of those assigned to greater than or equal to16-week dosing regimen at baseline, 70% maintained greater than or equal to16-week dosing intervals throughout the two-year study period. At the end of two years, 78% were eligible for greater than or equal to16-week dosing, with 53% eligible for greater than or equal to 20-dosing week intervals. The PULSAR trial met its primary endpoint last year with aflibercept 8 mg patients achieving clinically equivalent vision gains to EYLEA. Through two years, vision gains were sustained and remained largely consistent with the results at one year. In PULSAR, the safety of aflibercept 8 mg continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for wAMD. There were no cases of retinal vasculitis, occlusive retinitis or endophthalmitis in the aflibercept 8 mg group. The rate of intraocular inflammation was 1.3% for the aflibercept 8 mg group and 2.1% for the EYLEA group. Anti-platelet trialists’ collaboration-defined arterial thromboembolic treatment-emergent adverse events occurred in 1.8% of patients treated with aflibercept 8 mg and 3.3% of patients treated with EYLEA.