Earlier this week, Apellis Pharmaceuticals provided updates on its injection kits and rare events of retinal vasculitis reported in real-world treatment with Syfovre for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
A recent safety investigation concerning Syfovre injection kits has unveiled internal structural differences in a specific filter needle variant — the 19-gauge filter needles — present in certain kits. While Apellis has not found a "causal relationship" between the structural variations in this 19-gauge filter needle and the rare events of retinal vasculitis in the real world, the company is recommending that 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.
Signs of trouble began in early July, when the American Society of Retina Specialists (ASRS) received its initial report of retinal vasculitis, an inflammation endangering vision. Subsequently, within a week, six more incidents were reported to ASRS's Research and Safety in Therapeutics (ReST) committee. Apellis initiated its own inquiry, led by both an internal safety committee and external experts in retina/uveitis.
These instances encompassed injections from April to June. The investigation encompassed scrutinizing Syfovre's manufacturing process, drug quality, and safety data from phase 3 clinical trials. At the time, Apellis determined that neither product nor manufacturing issues played a role in the events, and reevaluation of the trials unveiled no new safety concerns.
To date, eight confirmed incidents of retinal vasculitis have been recorded, all transpiring after the initial injection. While effects varied among patients, with some maintaining stability or achieving recovery, others faced varying degrees of vision impairment. Two suspected cases are currently awaiting official confirmation.
Syfvore has been FDA-approved since May, stands as the lone remedy for GA, a chief cause of blindness. GA is a progressive, irreversible outcome of advanced age-related macular degeneration, where lesions develop, harming vital retinal cells for vision. Apellis' Syfovre strategically regulates the body's immune system by targeting C3, thus controlling the complement cascade.