Apellis Eye Injection Treatment Flagged for Safety Issues
Pictured: Healthcare worker checking the eye of an elderly woman patient/iStock, peakSTOCK
Apellis’ recently approved eye injection Syfovre (pegcetacoplan injection) has been linked to several cases of retinal vasculitis, a rare complication involving eye inflammation, according to the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee, as reported by several media outlets.
In a press statement posted Saturday, Apellis confirmed seven retinal vasculitis cases, two of which arose in April 2023 following Syfovre injections, while two others were detected in May and three in June. The company has also received a report of one other retinal vasculitis event, but has yet to confirm this.
Apellis has carried out a comprehensive investigation of these complications, including a review of Phase III safety data from Syfovre’s development program, as well as of its manufacturing process. However, “there is no indication that the drug product or manufacturing issues contributed to these events,” the company said in its announcement.
There were no changes in Syfovre’s formulation between its Phase III trials and commercial production, and Apellis found no problems with the product’s manufacturing, such as quality issues or contaminants. There were also no cases of retinal vasculitis reported during Syfovre’s Phase III studies.
“As part of our ongoing review, we have seen no indication that drug product or manufacturing issues contributed to these events,” co-founder and CEO Cedric Francois said in a statement.
Syfovre was approved in February 2023 as the first ever treatment for geographic atrophy secondary to age-related macular degeneration. The treatment, a complement inhibitor, works by targeting C3—the central player in the complement cascade—thereby regulating downstream immune responses.
In July, the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee flagged six cases of retinal vasculitis, which occurred one to two weeks after Syfovre injection and could potentially lead to blindness, according to a report by BioPharma Dive. Though these cases were not associated with any specific batch of the treatment, the committee nevertheless advised doctors to closely follow their patients after administration and asked them to report any similar cases.
Over the weekend, during the American Society of Retina Specialists’ annual meeting, new safety data showed that five elderly adults had gone blind after being treated with Syfovre, STAT reported.
Apellis has not yet publicly confirmed these cases of blinding, though the company did report efficacy data for the eye injection also during the ASRS annual meeting. In the GALE extension study, Syfovre continued to reduce lesion growth through 30 months of continuous treatment.
Monday, Apellis also released its second-quarter earnings report, highlighting Syfovre’s sales of $67.3 million, which accounts for more than half of the company’s net product revenue for the quarter.