An investigation into rare events of retinal vasculitis linked to Apellis Pharmaceutical’s new therapy, SYFOVRE, for geographic atrophy (GA) has identified “internal structural variations” in a 19-gauge filter needle used to withdraw treatment from the vial.
The company is now asking practitioners to immediately stop using injection kits that contain the 19-gauge filter needle and only use those with an 18-gauge filter needle.
Global biopharmaceutical company Apellis Pharmaceuticals created history early in 2023 with SYFOVRE when it became the first and only FDA-approved treatment for GA secondary to age-related macular degeneration (AMD). Also referred to as pegcetacoplan, the therapy is not yet approved in Australia.
The safety of SYFOVRE has been in the spotlight after reports of retinal vasculitis reported in real-world treatment.
In the latest update on 5 October 2023, Apellis said:
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- In total, there have been 10 confirmed cases of retinal vasculitis (seven occlusive, three non-occlusive) and two suspected cases.
- Since the last update on August 22, there was one new confirmed case that occurred in early August and two new suspected events. Of the two events that were previously classified as suspected, one has been confirmed and the other was adjudicated to not be retinal vasculitis.
- Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected cases are pending.
The company also reported the GALE study – (n=792) is a Phase 3, multicentre, open-label, extension study to evaluate the long-term efficacy and safety – at 30 months showed the safety profile of SYFOVRE continued to be consistent with previously reported Phase 3 data.
“The estimated real-world rate of retinal vasculitis remains rare, at 0.01% per injection,” Apellis stated.
“All suspected retinal vasculitis events reported to Apellis are independently evaluated and adjudicated by two external sources: a panel of four retina/uveitis experts and an independent reading centre as well as Apellis’ internal safety and medical teams.”
As part of a comprehensive investigation into the real-world safety events, Apellis said “internal structural variations” were identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits.
Filter needles are used to withdraw treatment from the vial when preparing for an injection procedure.
Although a causal relationship has not been established, the company has recommended practitioners immediately discontinue use of any injection kits that contain the 19-gauge filter needle and use injection kits with the 18-gauge filter needle, which are already in distribution.
While injection kits previously contained one of two types of filter needles (either 18- or 19-gauge), Apellis is now exclusively distributing injection 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. This recommendation is out of an abundance of caution as patient safety is our top priority,” said Dr Caroline Baumal, chief medical officer of Apellis.
In seven months, the company reported more than 100,000 vials have been shipped to physician practices, something chief commercial officer Mr Adam Townsend said is “a testament to the unmet need and the strength of SYFOVRE’s product profile”.
“SYFOVRE offers increasing treatment effects over time with as few as six doses per year,” he said.
“It is very encouraging to see the return to weekly growth in demand as physicians and patients have learned more about the long-term efficacy from the GALE study and real-world safety of SYFOVRE. With our permanent J-code now in place, we look forward to building on these trends and continuing to bring SYFOVRE to people living with this chronic disease.”
Apellis expects approximately US$74 million (AU$117 m) in preliminary US net product revenue for SYFOVRE in the third quarter and approximately US$160 million ($253 m) in preliminary total US net product revenue since launch in March 2023 through September 30, 2023.
More reading
FDA approves Apellis’ SYFOVRE for first geographic atrophy treatment
Prof Robyn Guymer: Is Australia ready for the latest AMD therapies?
The changing face of geographic atrophy
