Pegcetacoplan Saves 1.5 Years of GA Lesion Progression in GALE Extension, With Dilsher Dhoot, MD

Earlier pegcetacoplan treatment preserved twice as much retinal tissue compared to delayed treatment in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to the full 5-year GALE Extension study.¹

GALE was a phase 3, open-label, multicenter extension study evaluating pegcetacoplan’s efficacy and safety. Patients who completed treatment at month 24 of either the OAKS or DERBY study were eligible for inclusion in the trial, which was conducted at 175 locations worldwide.²

“After 60 months of treatment, a patient can expect to be where a patient in the sham group would have been 1.5 years earlier in terms of their GA lesion growth,” Dilsher Dhoot, MD, a vitreoretinal specialist with California Retinal Consultants, told Ophthalmology Times in an exclusive interview. “This certainly resonates with patients – you’re saving time for them, time with usable vision, hopefully.”

Patients were eligible for enrollment in GALE if they had not stopped drug treatment following DERBY or OAKS, and if their eyes had transparency to permit visualization of parts inside the eye, including the retina. Patients were also required to be able to look steadily at a provided target. Patients were excluded if they had fully stopped pegcetacoplan treatment after DERBY or OAKS, if they exhibited inflammation or infection around the eye, or if they had an allergy to fluorescein sodium or to pegcetacoplan, among other criteria.²

After enrollment, patients were assigned to receive pegcetacoplan 15 mg either monthly or every other month for ≤36 months. The primary outcome measure was incidence and severity of ocular and systemic adverse events over the course of the study; key secondary outcome measures included the change from baseline in total GA lesion area, in normal luminance best corrected visual acuity (NL-BCVA) score, and in low luminance BCVA score.²

A total of 780 patients were ultimately included in and completed the study. Over the course of 5 years, both the once monthly and once every other month treatment arms demonstrated substantially lower GA lesion progression compared to sham. Pegcetacoplan treatment ultimately resulted in a preservation of 3.9 mm2 of retinal tissue, equivalent to >1.5 disc areas.¹

Additionally, both the monthly treatment and every-other-month treatment arms saw roughly 1.5 years of disease progression saved, with the former saving around 18.5 months and the latter saving around 16.5 compared to projected sham. The safety profile for pegcetacoplan was also consistent with OAKS and DERBY, with no recorded events of occlusive or non-occlusive retinitis or vasculitis.¹

“These long-term data are very encouraging,” Dhoot said. “In fact, we see that we have increasing amounts of tissue that is preserved year over year. I believe that the difference between monthly and every other month dosing is reasonable and certainly tends to shift me more towards every other month dosing, which helps the patient with injection burden and also mitigates some of the safety issues that are dose dependent.”

Editors’ Note: Dhoot reports disclosures with 4DMT, Regeneron, Genentech, Outlook Therapeutics, Apellis, Novartis, and others.

References

1. Dhoot D, Garg S, Lally D, et al. Earlier Treatment Yields Better Outcomes: 5 Years of Pegcetacoplan Treatment for Geographic Atrophy Secondary to AMD. Abstract presented at the 49th Annual Macula Society Meeting in San Diego, CA. February 25-28, 2026.

2. Apellis Pharmaceuticals, Inc. An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD (GALE). ClinicalTrials.gov Identifier: NCT04770545. Updated October 24, 2025. Accessed March 6, 2026. https://clinicaltrials.gov/study/NCT04770545