Regeneron Pharmaceuticals, Inc. 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, MD, PhD, 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 consistent safety profile with substantially fewer treatments than EYLEA. If approved by regulatory authorities, aflibercept 8 mg has the potential to become the new standard of care for diabetic macular edema and wet age-related macular degeneration.”
PULSAR (N= 1,009) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg 12-week (n=335) and 16-week (n=338) dosing regimens compared to an 8-week dosing regimen for EYLEA (aflibercept) Injection (n=336).
All patients received three initial monthly doses. 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.