BLOG: What retina specialists should know following Syfovre inflammation reports
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Key takeaways:
- Six cases of intraocular inflammation and retinal vasculitis have been reported.
- Retina specialists should discuss risks with patients, follow recommended injection technique and report abnormalities.
The advancement of retinal therapies offers promise and hopefully no peril to those willing to push the boundaries of medical science into new indications.
This week, our retina community and patients heard about the recent cases of inflammation associated with Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals), our first FDA-approved treatment for geographic atrophy. This was after two phase 3 clinical trials with more than 1,200 patients with geographic atrophy, one of the largest to date, studied Syfovre for more than 24 months and demonstrated clinical benefit in both anatomy and vision with a relatively safe drug profile.
To date, there have been six cases of intraocular inflammation and retinal vasculitis after more than 60,000 vials of Syfovre that have been distributed in the real world since approval, translating into an event rate of less than one in 10,000 injections, or 0.01% per injection. Some of these cases appear to be infectious in etiology. This contrasts with the clinical trials, which demonstrated zero cases of retinal occlusive vasculitis.
So, what should retina specialists do? First and foremost, disclose this to your patients so all are aware and understand the risk of Syfovre. Continue to practice sterile technique for intravitreal injections and follow injection preparation guidelines such as utilization of filter needles and syringes as detailed on the package insert. This is different from most intravitreal anti-VEGF injections that we perform in both technique and amount delivered. And report any abnormalities you find to both the company and the American Society of Retina Specialists Research and Safety in Therapeutics (ReST) Committee so we can continue to monitor and learn from this matter.
Editor's note: This article was updated on July 19, 2023, to correct the distributed number of Syfovre vials.
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