Key Takeaways
- SYFOVRE (pegcetacoplan injection) delays GA lesion growth by approximately 1.5 years compared to sham treatment in AMD patients.
- The GALE study, an extension of OAKS and DERBY trials, confirms long-term efficacy and safety of pegcetacoplan with no new safety signals.
- Early and continuous treatment with SYFOVRE significantly alters the natural progression of GA, offering transformative benefits in disease management.
New five-year data reveal SYFOVRE significantly delays geographic atrophy progression, enhancing understanding of age-related macular degeneration treatment.
The company reported that pegcetacoplan injection—administered both monthly and every other month—delayed GA lesion growth by approximately 1.5 years compared with the sham.1
The phase 3 GALE study (NCT04770545) is a multicenter, open-label extension study of the OAKS (NCT03525613) and DERBY (NCT03525600) studies evaluating the long-term efficacy and safety of pegcetacoplan injection, the first-ever approved treatment for GA.1
Patients from the OAKS and DERBY studies, as part of the treatment arms through month 24, remained on the same regimen and were included in the GALE study.1
“These 5-year results underscore the transformative and durable impact of targeting C3 with Syfovre to delay the progression of GA,” Caroline Baumal, MD, chief medical officer of Apellis, said in a press release.1
“With the most extensive data set in GA, our broad clinical and real-world experience has greatly advanced the retina community’s understanding of this devastating disease and reinforced Apellis’ leadership.”
During the American Academy of Ophthalmology 2025 annual meeting, the Eye Care Network caught up with Esther Lee Kim, MD, who walked us through key points of the GALE study.
Source: Ophthalmology Times