ASRS ReST Committee sheds light on timeline of Syfovre inflammation reports
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SEATTLE — At the American Society of Retina Specialists annual meeting, the ReST Committee shared an update on intraocular inflammation reported in patients who received Syfovre.
Andre J. Witkin, MD, FASRS, chair-elect of the ASRS Research and Safety in Therapeutics (ReST) Committee, shared a timeline of events related to the cases of inflammation and Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals). He said that the first report of panuveitis with retinal occlusive vasculitis was received by ReST’s reporting system on July 3. ReST contacted Apellis to discuss safety concerns on July 5 and received reports of six additional cases over the next week.
On July 12, Witkin said, Apellis and the committee met to discuss severe intraocular inflammation and cases of vasculitis from post-marketing surveillance and clinical trials. ReST Committee members then unanimously agreed to prepare a member communication, which was discussed with Apellis. A draft of the communication was sent to the ASRS Executive Committee on July 14.
On July 15, members of the ASRS Executive Committee unanimously approved the communication, and a mock-up final member communication was reviewed and agreed to by Apellis. The member communication was released to ASRS members that same day.
On July 22, Apellis, the ASRS Executive Committee and ReST all agreed to hold this presentation at ASRS.
During the presentation, Witkin also shared details of the patient case reports.
“I want to make sure everybody understands how extensive the process is before a communication like this goes out. There are 10 members of the ReST Committee. It is extensively reviewed by those members and is presented to the Executive Committee, who spend a great deal of time reviewing it,” Jeffrey S. Heier, MD, said during a Q&A after Witkin’s presentation. “Any communications go through both of these processes multiple times before any communication or word goes out. There is a laborious, meticulous process before any communication goes out. The ReST Committee and Executive Committee of ASRS feel this responsibility very heavily and follow a process very extensively. The ReST Committee and Executive Committee did that. They were careful in this case.”
“When it comes to these adverse events, it is of critical importance that we hear about them very swiftly. I think this is one of the first times that the response to an adverse event has been extremely swift, not only on the part of our committees at ASRS, but really first and foremost from the industry person responsible for disseminating information and watching for safety,” Abdhish R. Bhavsar, MD, said during the Q&A. “I think it is very notable that someone should mention Caroline Baumal, chief medical officer [of Apellis]. She met with many of us personally on a very large Zoom meeting, shared data with us on patient information very early in the process, and was very open and honest. Frankly, in this world today when honesty is many times suppressed, that was very refreshing to see.”
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Witkin AJ. ReST Committee update on intraocular inflammation (IOI). Presented at: American Society of Retina Specialists annual meeting; July 28-Aug. 1, 2023; Seattle.
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