OR WAIT null SECS
Presented at AAO 2023, new 3-year data from the GALE extension study shows increasing treatment effects over time with pegcetacoplan injection for geographic atrophy.
New GALE extension trial data showed increasing treatment effects over 3 years with pegcetacoplan injection (SYFOVRE) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The results, presented at the 127th Annual American Academy of Ophthalmology (AAO) Meeting, showed pegcetacoplan reduced GA lesion growth with both monthly (35%; P <.0001) and every other month (24%; P <.0001), compared to the projected sham arm. Pegcetacoplan injection reduced nonsubfoveal GA lesion growth with both monthly (42%; P <.0001) and every-other-month (28%; P = .0015) treatment, compared to the projected sham arm.
The complement C3 inhibitor reduced GA lesion growth by 19% (P <.0001) after 1 year of pegcetacoplan treatment (combined monthly and every other month), compared to the sham treatment period, in individuals who crossed over from the sham group.
“In the real world, I am using pegcetacoplan and I am a believer in anti-complement therapy. I think it's a conversation to be had with each individual patient, what the risk-benefit ratio looks like,” said Charles C. Wykoff, MD, PhD, director of clinical research, Retina Consultants of Texas, in an interview with HCPLive. “I think those are the conversations that clinicians are having across the country and some patients are interested in engaging with this therapy, knowing they're not going to see better, but that you're going to slow the progression of the disease.”
GALE is a phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety of pegcetacoplan injection in patients with GA, secondary to AMD. More than 80% of participants who completed the OAKS and DERBY studies entered the GALE study
Analyses of the untreated fellow eye further validated the treatment effects observed in year 3. Among patients with bilateral GA, lesions tend to grow at similar rates in both eyes. The fellow eye analysis served as an additional control to assess the treatment effect of pegcetacoplan injection.
Safety analyses of pegcetacoplan injection remained consistent with previously reported data during year 3 of the study. In the first year of GALE, the rate of new-onset investigator-reported wet AMD was 7.1% in the monthly arm and 2.3% in the every-other-month arm. Investigators identified 1 serious adverse event of ischemic optic neuropathy in the monthly group between months 24 to 30, a previously reported event, and 1 case of endophthalmitis between months 30 to 36.
Moreover, the rate of intraocular inflammation was 0.26% per injection from months 0 to 36, which did not include 4 cases linked to the 2018 impurity of pegcetacoplan injection. There were no events of retinal vasculitis observed in the clinical trial program, following ≥24,000 injections to date; however, reports of vasculitis have been reported in the real-world use of pegcetacoplan injection, though they remain rare.
“Some physicians really see it as a move forward for the field and are engaged with this and think it's a useful add, and others, I think are more hesitant, largely driven by these many nuanced safety discussions. So it's a field that continues to evolve,” Wykoff said.
For more insight into GALE, watch the full interview with Dr. Wykoff.
Syfovre® (pegcetacoplan injection) continued to demonstrate increasing treatment effects over 3 years in patients with geographic atrophy (GA). Apellis Pharmaceuticals, Inc. November 4, 2023. Accessed November 4, 2023. https://investors.apellis.com/news-releases/news-release-details/syfovrer-pegcetacoplan-injection-continued-demonstrate-0.
Wykoff CC, Heier JS, Jones D, Yemanyi F, Nakabayashi M. Long-Term Efficacy and Safety of Pegcetacoplan From the GALE Open-Label Extension of the Phase 3 OAKS and DERBY Trials. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.