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A notification from the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee has linked Apellis’ pegcetacoplan injection (Syfovre) with a handful of cases of occlusive retinal vasculitis.
The issues were noted in a post on the ASRS website exclusively for its members, according to reports.
According to the ASRS ReST Committee's notice, ophthalmologists noted instances of intraocular inflammation (IOI) after the initial injection of pegcetacoplan. Moreover, the ASRS noted in its post the reports included instances of mild to moderate IOI, as well as severe IOI, retinal vasculitis, and occlusive retinal vasculitis.
In its July 15 notification, ASRS also noted the etiology of the events is not clear and the outcomes of the cases continue to unfold, according to reports.
In the pivotal phase 3 DERBY and OAKS trials, intraocular inflammation was noted in 2.1% (every other month) to 3.8% (monthly) of pegcetacoplan patients at 24 months. The IOI cases from the trials included 4 cases of infectious endophthalmitis and 4 cases of severe intraocular inflammation, but no cases of retinal vasculitis. Apellis reviewed images and clinical data from all cases of IOI from their clinical trials and no cases of retinal vasculitis were found on secondary review of those patients, ASRS noted.
The ASRS also indicated in its notification that Apellis has worked with the ReST committee to review and follow the cases and will keep the retinal field apprised of any new developments.
Ophthalmologists can report adverse events by visiting the ASRS website’s page for reporting cases of adverse instances.
In February, Apellis received FDA approval for pegcetacoplan injection for geographic atrophy, the first drug approved to treat the advanced stage of age-related macular degeneration.
Pegcetacoplan is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases.
Inclusion of the 24-month data, Apellis noted following the FDA approval, strengthened the product profile at launch, with minimal impact to launch timing, and is considered a major amendment to the NDA and extended the review period by 3 months.
The 24-month efficacy data were obtained from the Phase 3 DERBY and OAKS studies. According to a press release, “These data showed robust and consistent effects with monthly and every-other-month pegcetacoplan treatment in both studies. The 24-month safety data were previously submitted as part of the 120-day update.”
Apellis noted in a release announcing the approval that the 24-month phase 3 data “demonstrated robust and increasing effects over time.” The longer-term data provided an even stronger product profile at launch,” according to Cedric Francois, MD, PhD, chief executive officer and co-founder, Apellis.
The OAKS (n = 621) and DERBY (n = 637) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of pegcetacoplan with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies was to evaluate the efficacy of monthly and every-other-month pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence at 12 months. Patients continued to receive masked treatment for 24 months.