Ashkan M. Abbey, MD: 3-Year Efficacy of Pegcetacoplan for Geographic Atrophy

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At ARVO 2024, Ashkan Abbey, MD describes key data from the pivotal OAKS and DERBY, and the GALE extension trial over 3 years of pegcetacoplan treatment.

Highlights

0:07 Evolutions in Clinical Practice Since FDA Approval
0:50 36-Month Data on Pegcetacoplan for GA
2:02 Safety Profile Across 3 trials
4:13 Next Steps in GA Treatment
6:06 Biggest stories at ARVO 2024

More than a year on from its US Food and Drug Administration (FDA) approval, pegcetacoplan injection (SYFOVRE) from Apellis Pharmaceuticals has ushered in a new era of treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Meeting, long-term pooled data on pegcetacoplan from the pivotal phase 3 OAKS and DERBY studies and the GALE open-label extension study demonstrated favorable efficacy and consistent safety in patients with GA over 36 months.

In an interview with HCPLive Ophthalmology, Ashkan M. Abbey, MD, the director of clinical research at Texas Retina Associates, described the increasing treatment effect of pegcetacoplan over time, specifying a 42% reduction in nonsubfoveal GA lesion growth with monthly treatment.

“Right now, we have three-year data with respect to treatment with pegcetacoplan in these trials, and it just keeps on spreading out more and more, the space is bigger and bigger,” Abbey told HCPLive. “That really equates to more retinal tissue preserved.”

In OAKS and DERBY, eyes with GA secondary to age-related macular degeneration (AMD) were randomized 2:2:1:1 to pegcetacoplan monthly (PM), every other month (PEOM), sham monthly, or sham every other month, for 24 months. After OAKS and DERBY were completed, study participants could enroll in the GALE 3-year open-label extension study, with sham participants switching to pegcetacoplan treatment on the same regimen.

Upon analysis, across OAKS and DERBY (n = 1258), pegcetacoplan reduced GA lesion growth across all lesion subtypes by 21% with PM and 17% with PEOM (both P <.0001), compared with sham, from baseline to month 24.

Among eyes with non-subfoveal GA (n = 446), pegcetacoplan reduced GA lesion growth by 26% and 22% with PEOM (both P <.0001). In those with subfoveal GA (n =765), pegcetacoplan reduced GA growth by 19% with PM (P <.0001) and 16% with PEOM (P <.0003).

Visual function outcomes showed severe visual impairment, defined as a BCVA ≤35 ETDRS letters for ≥4 months without later recovery to ≥40 letters, was identified in 6.4%, 9.6%, and 12.0% of PM, PEOM, and sham-treated eyes, respectively, by month 24. This corresponded to a 38% (PM) and 12% (PEOM) reduced risk of progression to severe visual impairment with pegcetacoplan treatment.

Approximately 83% (n = 782) of patients who completed OAKS and DERBY enrolled in GALE, with 92% (n = 727) of these patients completing the first 12 months of GALE. During Months 24 to 36, the analysis showed pegcetacoplan reduced GA growth versus projected sham by 35% with PM and 24% with PEOM (both P <.0001).

In non-subfoveal GA, reductions were 42% with PM and 28% with PEOM; in subfoveal GA, reductions were 31% with PM and 25% with PEOM. Sham patients from OAKS and DERBY who initiated pegcetacoplan in GALE demonstrated a 19% reduction in GA growth versus projected sham at 12 months.

Safety remained consistent with that reported in OAKS and DERBY, with no new safety signals identified in the first 12 months of GALE. Abbey noted the 3-year data exhibited a slightly higher rate of conversion to wet AMD, an expected incidence of endophthalmitis, and a slight elevated risk of ischemic optic neuropathy with pegcetacoplan treatment.

“We are obviously focused on inflammation, which everyone is hyperfocused on because of the incidence of vasculitis that we’ve seen in the real world,” Abbey told HCPLive. “Still, somehow in the clinical trials, where we’ve done many, many injections of pegcetacoplan, we still have not seen a case of vasculitis over this 3-year data set in the trials.”

For more expert insight into the 36-month results of pegcetacoplan for GA, watch the full interview with Dr. Abbey.

Disclosures: Abbey reports financial support from Apellis Pharmaceuticals.

References

Abbey AM, Wykoff CC, Heier JS, Li C, Yemanyi F, Dieckmann G, Pereria D, Tsuboi M, Baumal C. Long-term efficacy and safety of pegcetacoplan over 36 months including 12-month results of the GALE open-label extension study. Paper presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Meeting, May 5–9, 2024.

Iapoce C. FDA approves Pegcetacoplan Injection for geographic atrophy. HCP Live. February 17, 2023. Accessed May 6, 2024. https://www.hcplive.com/view/fda-approves-pegcetacoplan-injection-geographic-atrophy.

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