GALE study assesses long-term efficacy, safety of pegcetacoplan for geographic atrophy

The GALE study demonstrated long-term safety and efficacy trends for patients with geographic atrophy (GA) who were treated with intravitreal pegcetacoplan. The study was presented at the 2024 ARVO Annual Meeting in Seattle, Washington.

The open-label extension study allowed patients participating in the phase 3 OAKS and DERBY studies to continue on or switch to pegcetacoplan after 2 years of treatment. In these trials, eyes were randomized 2:2:1:1 to receive:

• Pegcetacoplan monthly (n=419)
• Pegcetacoplan every other month (n=420)
• Sham monthly (n=208)
• Sham every other month (n=211)

Of the OAKS and DERBY cohorts, 782 patients (83%) entered the GALE study, and at 12 months, 92% of patients (n=727) were still enrolled in GALE.

Between months 24 (entrance to GALE) and 36 (1 year on trial), pegcetacoplan reduced GA growth versus projected sham by 35% with monthly treatment and 24% with bimonthly treatment (P<.0001 for both). Specifically, for patients with non-subfoveal GA (n=286), pegcetacoplan reduced GA growth by 42% with monthly treatment and 28% with bimonthly treatment. For subfoveal GA, these reductions were 31% and 25%, respectively.

Among patients originally in the sham cohorts in the OAKS and DERBY studies who initiated pegcetacoplan in GALE, there was a 19% reduction in GA growth versus projected sham at 12 months.

The researchers reported that the safety profile during the first 12 months of the GALE study was consistent with the OAKS and DERBY trials, with no new safety signals. With more than 215,000 injections administered, the rate of retinal vasculitis remained at approximately 1 in 10,000 per injection.

The researchers concluded that pegcetacoplan offers continued efficacy for patients with GA at up to 36 months.

Reference

Abbey AM, Wykoff CC, Heier JS, et al. Long-term efficacy and safety of pegcetacoplan over 36 months including 12-month results of the GALE open-label extension study. Abstract 380. Presented at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting, May 5-9, Seattle, Washington.