Apellis Reports 5-Year Data Showing Syfovre Significantly Delays Geographic Atrophy Progression

Apellis Pharmaceuticals has announced compelling new findings from a post hoc analysis of the GALE extension study, highlighting that continuous treatment with Syfovre (pegcetacoplan) over five years meaningfully slowed the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The data show that both monthly and every-other-month dosing regimens of Syfovre delayed GA lesion growth by approximately 1.5 years in patients with nonsubfoveal GA compared to sham or projected sham treatment.

“I’m very encouraged by these long-term results, which show that early and continuous treatment with Syfovre can meaningfully delay the progression of GA,” said Dilsher Dhoot, MD, of California Retina Consultants.
“Importantly, these data indicate that Syfovre alters the natural course of this disease, which causes irreversible vision loss and profoundly impacts patients’ daily lives.”

Durability of C3 Inhibition and Clinical Impact

Caroline Baumal, MD, Chief Medical Officer at Apellis, emphasized the significance of the results:

“These 5-year results underscore the transformative and durable impact of targeting C3 with Syfovre to delay the progression of GA. 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.”

The safety profile of Syfovre through 5 years remained consistent with prior findings, with no new safety signals reported. Apellis intends to present the full data at an upcoming medical conference.

About the GALE Extension Study

The GALE study (n=792) is a phase 3, multicenter, open-label extension trial evaluating the long-term efficacy and safety of Syfovre in patients with GA secondary to AMD. More than 80% of patients from the pivotal OAKS and DERBY trials transitioned into GALE.

The study’s objectives include:

       • Assessing the long-term incidence and severity of ocular and systemic treatment-emergent adverse events

       • Monitoring changes in total GA lesion area, measured by fundus autofluorescence imaging

Methodology: Projecting Disease Progression Beyond Initial Sham Arms

The 5-year lesion growth analysis included patients who received Syfovre through Month 24 in OAKS and DERBY and continued on the same dosing regimen in GALE. As sham-treated patients transitioned to active treatment after Month 24, a projected sham arm was utilized to estimate untreated progression from Months 24 to 60.

This projection was modeled using a fellow eye analysis and based on the linear lesion growth rate observed in the sham arms of the OAKS and DERBY trials during the initial two years.