SYFOVRE® (pegcetacoplan injection) Preserved Visual Function at 36 Months in GALE Extension Study in Geographic Atrophy (GA)

2024-06-11

研发

临床结果上市批准

SYFOVRE is the only approved GA treatment to demonstrate a visual function benefit in a prespecified endpoint

Data presented at the Clinical Trials at the Summit Meeting

June 10, 2024 - Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that SYFOVRE® (pegcetacoplan injection) preserved visual function at 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). These positive data from the GALE long-term extension study were presented at the Clinical Trials at the Summit (CTS) Meeting on June 8 in Park City, Utah.

“SYFOVRE is the only approved GA treatment to show a benefit on visual function in a prespecified endpoint,” said Dilsher Dhoot, M.D., presenting author, vitreoretinal surgeon, California Retina Consultants, Santa Barbara, CA. “The vision loss caused by GA is devastating for patients, taking away their ability to drive and read. These groundbreaking data clearly demonstrate SYFOVRE’s potential to make a meaningful difference for patients.”

In a prespecified microperimetry endpoint, patients developed fewer new scotomatous points with 36 months of both continuous monthly (p=0.0156) and every-other-month (p=0.1233) treatment compared to patients from the sham crossover group (all p-values nominal). Scotomatous points measure areas of the retina that have lost all light sensitivity and therefore are no longer functioning.

“These results further reinforce the importance of slowing GA lesion growth to preserve visual function, adding to the largest body of evidence for a GA treatment,” said Caroline Baumal, M.D., chief medical officer, Apellis. “As leaders in GA, we are committed to advancing our understanding of the benefits of SYFOVRE on this progressive and long-term disease.”

View full table by clicking on this link or the image below:

About the GALE Long-Term Extension Study

GALE (n=792) is a Phase 3, multicenter, open-label, extension study to evaluate the long-term efficacy and safety 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. GALE also includes 10 patients who were previously enrolled in the Phase 1b study of pegcetacoplan for GA.

Patients in the sham crossover group completed sham treatment from Months 0-24 in the Phase 3 OAKS study and received SYFOVRE from Months 24-36. Microperimetry was a key secondary endpoint measured only in the OAKS study, and therefore, patients who crossed over from the OAKS study were included in this analysis.

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 Phase 3 studies at 24 months, both every-other-month and monthly SYFOVRE reduced GA lesion growth with increasing effects over time and showed a well-demonstrated safety profile.

About SYFOVRE® (pegcetacoplan injection)

SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (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

About Apellis

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.

2Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.

3Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

The content above comes from the network. if any infringement, please contact us to modify.

机构