Regeneron's Aflibercept 8mg Shows Sustained Vision Gains At Two Years

Regeneron Pharmaceuticals Inc REGN announced two-year (96 weeks) topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet age-related macular degeneration (wAMD). 

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 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.

In June, the FDA issued a Complete Response Letter for Regeneron's aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler.

The FDA has stated that it intends to prioritize the review of this submission. Therefore the company anticipates the FDA will take action on the aflibercept 8 mg BLA during Q3 of 2023.

PULSAR study (N= 1,009) evaluated the 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. 

Price Action: REGN shares are up 1.00% at $793.50 on the last check Thursday.