2026년 2월 19일 · Unknown · financial · 출처 Yahoo Finance
Apellis Pharmaceuticals, Inc.
Company will debut five-year results from GALE study showing meaningful impact of early and continuous treatment with SYFOVRE® (pegcetacoplan injection)
WALTHAM, Mass., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that eight abstracts were accepted for oral presentations at the 49th Macula Society Annual Meeting, taking place February 25-28 in San Diego, California.
New data to be presented include the comprehensive analysis from the GALE extension study following five years of continuous treatment with SYFOVRE® (pegcetacoplan injection), the most prescribed treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
“We look forward to sharing the five-year results from our GALE extension study, which show the importance of early treatment with SYFOVRE for preserving retinal tissue and delaying disease progression in patients with geographic atrophy,” said Caroline Baumal, M.D., chief medical officer, Apellis. “Backed by the largest GA data set with the longest follow-up, these new findings demonstrate the clinically meaningful impact that SYFOVRE can have for patients living with this devastating disease.”
The oral presentation of the GALE data, “Earlier Treatment Yields Better Outcomes: 5-Years of Pegcetacoplan Treatment for Geographic Atrophy Secondary to AMD,” will take place on Friday, February 27 at 11:25 a.m. PT, presented by Dilsher S. Dhoot, M.D.
Additional presentations include:
OCT-F: AI-Enabled Retinal Function from Structural OCT- Results from OAKS & DERBY – Jay Chhablani – Wednesday, February 25, 5:10 – 5:15 p.m. PT Real-world Pegcetacoplan and Anti-VEGF Treatment Patterns among Patients with Geographic Atrophy – Theodore Leng – Thursday, February 26, 11:18 – 11:23 a.m. PT Retrospective Comparative Analysis of Demographic and Clinical Profiles in Pegcetacoplan-Treated and Untreated Patients With Geographic Atrophy – Nimesh Patel – Thursday, February 26, 11:23 am – 11:28 a.m. PT Factors Affecting Disease Progression and Vision Loss in Geographic Atrophy: Findings from OAKS and DERBY – David Boyer – Friday, February 27, 11:15 – 11:25 a.m. PT Fellow Eye Analysis, Including Ellipsoid Zone (EZ) Loss, in Bilateral GA due to AMD: Long-term Data from the OAKS, DERBY, and GALE Studies – Sunir Garg – Friday, February 27, 11:35 – 11:45 a.m. PT Can Visual Acuity be Estimated from Multimodal Imaging of Geographic Atrophy in Age-related Macular Degeneration? – Ivan Suner – Friday, February 27, 11:55 – 12:05 p.m. PT AI in GA: Learnings from the Pegcetacoplan Clinical Program – Diana V. Do – Saturday, February 28, 8:55 – 9:00 a.m. PT
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About GALE Long-Term Extension Study
GALE (n=792) is a Phase 3, multicenter, open label, extension study to evaluate the long-term safety and efficacy of SYFOVRE® (pegcetacoplan injection) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The objectives of the study are to evaluate the long-term incidence and severity of ocular and systemic treatment emergent adverse events as well as change in the total area of GA lesions as measured by fundus autofluorescence. More than 80 percent of participants who completed the OAKS and DERBY studies entered the GALE study.
Patients included in the 5-year GALE lesion growth reduction analyses were in the SYFOVRE treatment arms through Month 24 in the OAKS and DERBY studies and remained on the same regimen in GALE. Sham-treated patients in the Phase 3 OAKS and DERBY studies were eligible to transition to SYFOVRE treatment in GALE after Month 24, so a projected sham arm was used to estimate the growth of GA lesions without treatment between Months 24 and 60. The projected sham arm is based on the observed linear growth of GA lesions over two years and was validated by a fellow eye analysis. It was estimated as the average 12-month mean rate of change in the OAKS and DERBY sham arms through Month 24.
About the Phase 3 OAKS and DERBY Studies
OAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of SYFOVRE® (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence.
In these studies at 24 months, both every-other-month and monthly SYFOVRE reduced GA lesion growth with increasing effects over time and a well-demonstrated safety profile.
About SYFOVRE® (pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for GA. By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3
U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection)
CONTRAINDICATIONS
SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and i…