Apellis Provides Updates on Injection Kits and Rare Safety Events with SYFOVRE (pegcetacoplan injection) - Seite 2

• Over 100,000 SYFOVRE vials have been distributed in the real world and for administration in clinical trials. This includes:
  
  
  • Over 78,000 vials distributed since launch, including commercial vials shipped and sample vials distributed to physician practices. Over 26,000 vials distributed in the third quarter to date.
    
  • Approximately 24,000 SYFOVRE injections administered in clinical trials to date.
    
• In total, eight events of retinal vasculitis (five occlusive, three non-occlusive) have been confirmed. The last confirmed event of retinal vasculitis occurred on June 20, based on a review of adverse events reported to the Company.
  
  
  • This includes one additional event of occlusive retinal vasculitis, which occurred in May, and was reported after our last communication on July 29.
    
  • Two of the patients had their SYFOVRE injection in April, three in May, and three in June.
    
  • All events of retinal vasculitis were observed after the first injection of SYFOVRE.
    
  • One patient remained stable at baseline vision, two patients have recovered vision nearly back to baseline, two patients have severe vision impairment which is unlikely to be resolved, and three patients’ outcomes are still pending.
    
• There are two events of suspected retinal vasculitis. As previously disclosed, there was one event that occurred in May and the patient’s vision has returned to baseline. The other event occurred in August and the patient’s outcome is pending. Neither event has been confirmed.
  

All post-marketing adverse events reported to the company, including events of retinal vasculitis, are reviewed by Apellis’ Medical and Safety Committee. Any suspected events of vasculitis are also evaluated by external retina/uveitis specialists for adjudication.

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