Apellis has identified a possible culprit for the safety events affecting a small number of patients who received its geographic atrophy (GA) treatment — with a safety review pointing to the injection kit, rather than the drug itself.
While not establishing a causal relationship, Apellis said it had identified “internal structural variations” in the 19-gauge filter needle that’s used in some of its injection kits for Syfovre (pegcetacoplan).
Syfovre, the first-in-class treatment for GA secondary to age-related macular degeneration, was approved for use in the United States in February. Marketing applications are currently under review with five regulatory agencies worldwide, with decisions in Australia expected in the first half of 2024.
Confirmed Adverse Side Effects
In July it was announced that physicians had reported vision-threatening side effects following the administration of Syfovre. In total, eight events of retinal vasculitis (five occlusive, three non-occlusive) have been confirmed.
Of these, two patients have severe vision impairment that is unlikely to be resolved; one patient remains stable at baseline vision; two patients have recovered vision nearly back to baseline; and three patients’ outcomes are still pending.
There are two unconfirmed events of suspected retinal vasculitis.
the events of retinal vasculitis continue to be very rare at an estimated real-world rate of 0.01% per injection
Apellis Safety Review
In a media release, Apellis has announced that as part of a comprehensive investigation into the real-world safety events, internal structural variations were found in the 19-guage filter needle, used to withdraw treatment from the vial when preparing for an injection procedure.
It recommends practitioners immediately discontinue use of any injection kits that contain the 19-guage needle, and use injection kits with the 18-guage needle. The kits with 18-guage needles are already in distribution.
Apellis Chief Medical Officer Dr Caroline Baumal said the events of retinal vasculitis were “very rare”.
“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 rate of 0.01% per injection.
“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,” Dr Baumal said.
Apellis is preparing to face off to a new competitor in the market, after Iveric Bio received United States Food and Drug Administration approval for use of its new drug for GA, Izervay, in early August.
While both drugs target the complement pathway, Syfovre blocks the C3 cyclic peptide, while Izervay is a C5 inhibitor.
AMD is responsible for half of all blindness and severe vision loss in Australia. It causes progressive loss of central vision, impacting people’s ability to read, watch TV, drive, and recognise faces.
