Sunir J. Garg, MD: Pegcetacoplan Preserves Visual Function on Microperimetry

Pegcetacoplan injection (SYFOVRE) for geographic atrophy (GA) over 36 months led to fewer absolute scotomatous points, compared with eyes that had delayed treatment, according to data presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting.

These data suggest the efficacy of pegcetacoplan injection in preserving visual function, and the advantage of earlier treatment, for patients with GA who experienced irreversible loss of vision over time.

In an interview with HCPLive, Sunir Garg, MD, an attending physician on the Retina Service at Wills Eye Hospital, noted these data mark the first time a GA therapy has displayed a positive visual function benefit according to a prespecified endpoint.

“This was a big deal, because this was the first time, in a pre-specified endpoint, that we showed that eyes that received pegcetacoplan monthly had better preservation of points on the micropermitry,” Garg told HCPLive.

This analysis evaluated the number of new scotomatous points on microperimetry across the Phase 3 clinical program for pegcetacoplan injection for GA secondary to age-related macular degeneration (AMD). Microperimetry marks the only visual function endpoint to show a meaningful relationship with GA lesion growth over time.

The pivotal randomized, double-masked, sham-controlled Phase 3 OAKS trial showed a meaningful reduction in GA growth compared with sham treatment over 24 months, with increasing efficacy over time.

After OAKS was completed, patients enrolled in the GALE 3-year open-label extension study. Patients receiving pegcetacoplan in OAKS continued the same monthly (PM-to-PM) or every-other-month (PEOM-to-PEOM) dosing regimen. Sham-treated patients crossed over to active pegcetacoplan treatment at the same dosing interval.

Microperimetry was acquired every 6 months in OAKS and continued in GALE. At each visit, the number of new absolute scotomatous points (–1 dB) across the 68-point grid was recorded.

Prespecified microperimetry endpoint results from GALE showed eyes treated with PM for 36 months exhibited fewer new absolute scotomatous points, compared with eyes with 12 months of PM treatment (difference, –2.9 [95% CI, –5.3 to –0.6]; P = .0156).

Meanwhile, eyes treated with PEOM for 36 months showed fewer new absolute scotomatous points than eyes with 12 months of PEOM treatment (difference, –2.0 [95% CI, –4.5 to 0.5]; P = .1233).

“Post-hoc analyses are always no question in terms of their scientific rigor, but a pre-specified endpoint is a higher bar, and now that we've shown that, it gives us great encouragement that the trend that we were seeing previously is borne out in the 36-month data.,” Garg told HCPLive.

Disclosures: Relevant disclosures for Garg include Apellis, Coherus, Genentech/Roche, Regeneron, and others.

Reference

_{Garg SJ. Visual Function Benefit of Pegcetacoplan on a Prespecified Microperimetry Endpoint after 36 Months of Continuous Treatment from GALE. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024.}