Apellis Provides Update on Review of Rare Safety Events with SYFOVRE (pegcetacoplan injection) for Geographic Atrophy - Seite 2

• Apellis re-reviewed all intraocular inflammation (IOI) cases and confirmed no vasculitis events
  
• External retina/uveitis specialists re-reviewed all severe IOI cases and further confirmed no vasculitis events
  

Apellis is working closely with the retina community as it continues to investigate potential contributing factors and plans to continue to provide updates.

Apellis also provided an update on the events of retinal vasculitis reported to date:

• Since launch, Apellis has in total seven confirmed events of retinal vasculitis (4 occlusive, 3 non-occlusive) as determined by Apellis' internal safety committee and external retina/uveitis specialists. Two of these events followed injections in April, two in May, and three in June.

• Apellis is also evaluating one reported event of retinal vasculitis, which the Company has not confirmed.
  

Apellis can only review and confirm cases that have been reported directly to the Company and will continue to submit all reported adverse events to the U.S. Food and Drug Administration (FDA) consistent with reporting guidelines for drug manufacturers.

As of July 29, 2023, more than 68,000 vials of SYFOVRE have been distributed since FDA approval, including commercial vials shipped and sample vials distributed to physician practices. In addition, more than 23,000 SYFOVRE injections have been administered in clinical trials to date.

Seven oral presentations on SYFOVRE and GA will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting which is being held July 28 to August 1 in Seattle. Highlights will include new 30-month safety and efficacy data of SYFOVRE in patients with GA from the GALE long-term extension study.

SYFOVRE was approved by the FDA on February 17, 2023 based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and clinically diverse population of more than 1,200 patients.

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.