In the United States, six cases of retinal vasculitis have been reported after injecting Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) – the first and only drug to treat geographic atrophy in age-related macular degeneration (AMD).
The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee issued a notification disclosing these safety concerns to ASRS members.
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.
The six reported cases occurred seven to 13 days after the first injection of Syfovre. No specific lots were implicated.
The US Food and Drug Administration (FDA) approved pegcetacoplan in February. It is not yet approved for use in Australia or New Zealand.
reports encompassed instances of mild-moderate IOI, as well as severe IOI, retinal vasculitis, and occlusive retinal vasculitis
In the pivotal phase 3 DERBY and OAKS trials, 2.1% (every other month) to 3.8% (monthly) of Syfovre patients experienced IOI at 24 months. Among the cases of IOI from these trials, there were four instances of infectious endophthalmitis and four cases of severe IOI, 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.
Occlusive retinal vasculitis is a rare and serious eye condition that involves inflammation and blockage of the blood vessels in the retina. The severity of the condition can vary, and in some cases, it can result in permanent vision loss if not promptly diagnosed and treated.
We are in the process of thoroughly investigating all cases with external experts, including real-world procedure technique and potential risk factors
Thorough Investigation
In a statement to online news agency Medscape Medical News, Apellis said the rate of retinal vasculitis in real-world use was about 0.01% per injection.
“We are in the process of thoroughly investigating all cases with external experts, including real-world procedure technique and potential risk factors,” the statement said.
Meantime, Apellis, in a news release, announced that seven abstracts will be presented as oral presentations at the ASRS Annual Scientific Meeting to be held later this month in Seattle.2 The company said the upcoming data further reinforces the efficacy and safety profile of its drug.
“The breadth of Syfovre data at ASRS is a testament to the excitement surrounding the first and only FDA approved treatment for GA, which provides flexible dosing and slows GA lesion growth with increasing treatment effects over time,” said Dr Caroline Baumal, the Chief Medical Officer at Apellis.
Apellis’ product information notes that the drug is contraindicated in patients with ocular or periocular infections, and in patients with active IOI. It also warns that in clinical trials, use of Syfovre was associated with increased rates of neovascular (wet) AMD or choroidal neovascularisation (12% when administered monthly, 7% when administered every other month and 3% in the control group) by month 24.2
References
- Kirkner, R.M., Specialist group warns on complications from recently approved drug for geographic atrophy. Medscape Medical News, 18 July 2023, available at: medscape.com/viewarticle/994508 [accessed 24 July 2023].
- Apellis, Apellis announces seven abstracts accepted for oral presentation at the American Society of Retina Specialists (ASRS) annual scientific meeting (news release), available at: investors.apellis.com/news-releases/news-release-details/apellis-announces-seven-abstracts-accepted-oral-presentation [accessed 24 July 2023].
