After the initial approval of Apellis Pharmaceuticals' geographic atrophy drug Syfovre (pegcetacoplan injection), six cases of retinal vasculitis have been reported. The ASRS Research and Safety in Therapeutics (ReST) Committee issued a notification disclosing these safety concerns to ASRS members, resulting in a significant decline in Apellis' shares on Monday, closing down approximately 38%.
According to the ASRS ReST Committee, physicians have reported cases of intraocular inflammation (IOI) following the administration of Syfovre. These reports encompassed instances of mild-moderate IOI, as well as severe IOI, retinal vasculitis, and occlusive retinal vasculitis.
To date, the ASRS has received six cases of occlusive retinal vasculitis, all of which were observed after the first injection of Syfovre, occurring between 7-13 days after drug administration, and with no specific lots implicated.
“The etiology of these events is unclear, and outcomes in these patients are still evolving,” according to the ASRS notification, dated July 15, 2023.
In the pivotal phase 3 DERBY and OAKS trials, 2.1% (every other month) to 3.8% (monthly) of Syfovre patients experienced intraocular inflammation at 24 months. Among the cases of IOI from these trials, there were 4 instances of infectious endophthalmitis and 4 cases of severe intraocular inflammation, but no occurrences of retinal vasculitis were reported.
Apellis conducted a thorough examination, reviewing images and clinical data from all IOI cases in their clinical trials, and ASRS confirmed that no cases of retinal vasculitis were identified during the secondary review of those patients.
Apellis reported that approximately 60,000 vials of Syfovre have been distributed since the FDA approval on February 17, 2023.
In their ASRS note, Apellis mentioned that they are collaborating closely with the ReST committee to monitor these cases and intend to provide updates to the retina community as information becomes available.
Practitioners can report any adverse events by clicking on the ASRS link provided here.
Occlusive retinal vasculitis is a rare and serious eye condition that involves inflammation and blockage of the blood vessels in the retina, which is the light-sensitive tissue at the back of the eye. The term "occlusive" refers to the blockage or closure of these blood vessels.
When the retinal blood vessels become inflamed and blocked, it can lead to reduced blood flow to the retina, causing damage to the retinal cells and potentially leading to vision problems. The severity of the condition can vary, and in some cases, it can result in permanent vision loss if not promptly diagnosed and treated.