Data from the 30 month GALE extension study indicated that continuous treatment with pegcetacoplan injection showed increasing beneficial effects over that timeframe in patients with geographic atrophy (GA).
Apellis Pharmaceuticals, Inc. announced the results from the GALE extension study that indicated that continuous treatment with SYFOVRE (pegcetacoplan injection) for 30 months continued to show increasing beneficial effects over that timeframe in patients with geographic atrophy (GA). Pegcetacoplan is the first and only FDA-approved treatment for GA associated with age-related macular degeneration (AMD).
The company announced the data at the 2023 annual meeting of the American Society of Retina Specialists in Seattle.
The top-line results of the GALE study were that:
In commenting on the results, Caroline Baumal, MD, chief medical officer of Apellis, said, “The GALE results showed that SYFOVRE continues to demonstrate robust and increasing effects through 30 months with both monthly and every-other-month treatment. We are especially excited by the data showing that SYFOVRE reduced GA lesion growth by up to 45% in patients with non-subfoveal lesions.”
In the GALE study, which included 792 patients, the reduction in the growth of GA lesions with monthly injections was 39% and with every-other-month injections 32% (p<0.0001 for both comparisons) between months 24 and 30 compared to the sham treatment arm.
Pegcetacoplan also reduced the growth of non-subfoveal GA lesions with both treatment schedules, respectively, 45% and 33% (p<0.0001 and p=0.0023, respectively) during the same timeframe compared with sham therapy.
“These positive long-term results deepen our understanding of SYFOVRE as a meaningful therapy for this progressive and irreversible disease, adding to the most robust dataset ever collected in GA. It is very encouraging to see that SYFOVRE continues to work better and better the longer a patient is on treatment,” commented Nathan Steinle, MD, from California Retina Consultants, San Luis Obispo, CA,who presented the data.
The patients in the GALE study were from the phase 3 OAKS and DERBY trials and had been treated for 24 months before transitioning to the extension trial. More than 80% of the patients who completed the OAKS and DERBY studies entered the GALE study.
The safety profile of pegcetacoplan in the GALE study was consistent with the phase 3 data. The rate of exudative AMD was consistent with the phase 3 studies, ie, 7.5 and 7.2 events with monthly treatment and 3.9 and 3.6 events with every-other-month treatment per 100 patient years at months 24 and 30, respectively.
Between months 24 and 30, no non-serious ischemic optic neuropathy developed in either treatment group, and 1 serious case of ischemic optic neuropathy occurred in the monthly group. No cases of endophthalmitis developed from months 24 to 30.
The investigators reported a rate of intraocular inflammation of 0.26% per injection among all patients treated with pegcetacoplan in the phase 3 program. There were no cases of retinal vasculitis in the pegcetacoplan clinical trial program, after more than 23,000 injections to date.
Apellis reported that marketing applications are currently under review with five regulatory agencies worldwide. A decision in the EU is expected in early 2024, and decisions in Canada, Australia, Switzerland, and the United Kingdom are expected in the first half of 2024.