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Apellis Pharmaceuticals identified internal structural variations in the 19-gauge filter needle included in certain injection kits for pegcetacoplan injection, the first FDA-approved treatment for geographic atrophy.
Apellis Pharmaceuticals has shared an update on injection kits and events of retinal vasculitis reported with the use of pegcetacoplan injection (SYFOVRE) in the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).1
Announced on August 22, the investigation revealed internal structural variations in the 19-gauge filter needle included in certain injection kits and the company now recommends the use of kits with the 18-gauge filter needle.
“Based on the findings from our investigation, we believe it is prudent that practitioners only use the kits with the 18-gauge filter needle, which are already in distribution,” said Caroline Baumal, MD, chief medical officer of Apellis, in a statement.1 “This recommendation is out of an abundance of caution as patient safety is our top priority.”
Filter Needle Updates
An investigation into real-world safety events identified internal structural variations in the specific 19-gauge x 1 ½ inch filter needle included in certain injection kits. Filter needles withdraw treatment from the vial when preparing for an injection procedure.
The release noted a causal relationship has not been established between the structural variations in the 19–gauge filter needle and the rare event of retinal vasculitis in real-world treatment.
Practitioners were urged to immediately discontinue the use of any injection kits that contain the 19–gauge filter needle. Injection kits previously contained one of two types of filter needles (either 18- or 19-gauge), but the company is now exclusively distributing injection kits with the 18-gauge filter needle.
Retinal Vasculitis Events
The release indicates more than 100,000 vials of pegcetacoplan injection have been distributed in real-world practice and for administration in clinical trials, including 78,000 vials since launch, 26,000 vials in the 3rd quarter, and approximately 24,000 in clinical trials to date.
Overall, 8 events of retinal vasculitis have been confirmed: 5 occlusive events and 3 non-occlusive events. The last confirmed event of retinal vasculitis occurred on June 20, after a review of adverse events reported to Apellis.
These events include one additional confirmed event of occlusive retinal vasculitis occurring in May, which was reported after the company’s last communication on July 29. Of the population with retinal vasculitis, 2 patients had pegcetacoplan injection in April, 3 patients had an injection in May, and 3 patients had an injection in June.
All observed events of retinal vasculitis occurred after the first injection of pegcetacoplan injection. A single patient remained stable at baseline vision, 2 patients recovered vision nearly back to baseline, 2 patients had severe vision impairment unlikely to be resolved, and 3 patient outcomes are still pending.
The release detailed 2 events of suspected retinal vasculitis, including the event in May, where the patient’s vision returned to baseline. The other event occurred in August and the patient’s outcome is still pending. The company indicates neither event has been confirmed.
“To date, more than 100,000 vials have been distributed for commercial use and for administration in clinical trials, and the events of retinal vasculitis continue to be very rare at an estimated real-world of 0.01% per injection,” Baumal said.1 “We believe SYFOVRE is an important medicine for patients living with this chronic disease and are committed to providing patients with a meaningful and safe treatment.”
In February 2023, pegcetacoplan injection, a complement C3 inhibitor, was the first approved therapy by the US Food and Drug Administration (FDA) for the treatment of GA secondary to AMD.2 In August, the FDA approved avacincaptad pegol intravitreal solution (IZERVAY), a complement C5 inhibitor, marking the second available treatment in the class for GA secondary to AMD.3
At the American Society of Retina Specialists (ASRS) 41st Annual Meeting, Dilsher Dhoot, MD, a vitreoretinal surgeon at California Retina Consultants, stressed the importance of awareness of the risk of retinal vasculitis with pegcetacoplan injection, particularly when consenting patients on the risk.4
“I think, in general, consent is important, but I do believe there are efficacy benefits for this drug which can help patients, but it really does require a frank discussion with patients,” Dhoot said.