The company believes the 19-gauge filter needles may be the culprit in the SYFOVRE injections.
Apellis Pharmaceuticals Inc. provided an update on rare events of retinal vasculitis associated with SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Apellis conducted an internal investigation1 into the real-world safety events, according to a press release from the company. The investigation showed “structural variations were identified in the specific 19-gauge x 1½-inch filter needle included in certain injection kits.”1 Due to this, Apellis recommends that practitioners immediately discontinue the use of any injection kits containing the 19-gauge filter needle and use kits with the 18-gauge filter needle.
Injection kits with the 19-gauge filter needle are already in distribution according to the company. Injection kits previously came with one, either an 18-gauge or a 19-gauge needle, but now Apellis is exclusively distributing kits with the 18-gauge filter needle.1
While the company has stated practitioners stop use of the 19-gauge needle, the company stated “a causal relationship has not been established between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world.”1
“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. This recommendation is out of an abundance of caution as patient safety is our top priority,” said Caroline Baumal, MD, chief medical officer of Apellis.
To date, over 100,000 SYFOVRE vials have been distributed for real-world and clinical trial use.1
Overall, 8 events of retinal vasculitis have been confirmed. This includes the most recent confirmed event which occurred in June. Additionally, one event of occlusive retinal vasculitis occurred in May but was reported after the company’s last communication on July 29.1
There are 2 events of suspected retinal vasculitis. In the event that occurred in May, 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 fully.1