Apellis Pharmaceuticals issued a safety update Aug. 22 regarding cases of rare, vision-threatening retinal vasculitis associated with injections of Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The Waltham, Massachusetts, company said that its investigation uncovered internal structural variations in the 19-gauge filter needle included in certain injection kits.

Apellis stressed that it hadn’t found a causal relationship between the needles and the cases of retinal vasculitis, but it nevertheless recommended that practitioners immediately discontinue use of the 19-gauge needle and instead use kits with an 18-gauge filter needle, which are already in distribution.

Apellis’ injection kits previously contained either 18- or 19-gauge needles, but the company is now exclusively distributing the 18-gauge filter needle.

Syfovre was approved by the US FDA in February. In mid-July, the American Society of Retina Specialists (ASRS) issued a letter to doctors flagging cases of eye inflammation and six reports of occlusive retinal vasculitis in patients who received the drug.

Apellis subsequently launched its own investigation. In late July, the company reported that it found “no indication of drug product or manufacturing issues” tied to Syfovre.

Apellis says it has uncovered eight events of retinal vasculitis in total, five occlusive and three non-occlusive. Two other cases are suspected. The last confirmed retinal vasculitis case occurred on June 20, 2023, the company said in its safety update.

Apellis said that all of the cases to date have occurred after the first injection of Syfovre. One patient remained stable at baseline vision, and two patients have recovered vision nearly back to baseline. Two patients have “severe vision impairment, which is unlikely to be resolved,” and the other three patients are still being evaluated, Apellis said.

More than 100 thousand Syfovre vials have been distributed either commercially or for administration in clinical trials, Apellis said.

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