Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues
In late July 2023, we learned more about the Syfovre adverse reaction cases involving patient eye inflammation side effects such as retinal vasculitis. From Apellis Pharmaceuticals there was an update on the number of patients using Syfovre who have developed severe eye problems. And the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee provided a time of significant events to date.
We begin our continuing coverage of Syfovre adverse reaction cases with new details found in this July 31, 2023, BioPharma Dive news article, "Apellis faces safety doubts for fast-selling eye drug":
On [July 29, 2023], Apellis said that, since the February U.S. approval of its drug Syfovre in geographic atrophy, seven instances of a type of eye inflammation called retinal vasculitis have been confirmed by its internal safety committee and outside retinal specialists. Four were classified as “occlusive,” a possibly blinding condition in which blood flow to the retina is blocked.
Two cases of retinal vasculitis occurred in April, two in May and three in June, according to Apellis. The company is also evaluating, but hasn’t yet confirmed, one additional reported case....
Apellis’ figures differ slightly from those compiled so far by a safety committee advising the American Society of Retinal Specialists, which flagged the side effects to doctors earlier this month. Slides presented at the organization’s yearly meeting this weekend showed seven confirmed instances of occlusive retinal vasculitis, and another “suspected” case currently being reviewed....
Safety has been a concern before. The risk of side effects that were observed in testing, such as inflammation and the formation of new blood vessels in the eye, may grow with time. And though new data show the drug’s effects on eye lesions may also increase as patients receive more injections, Apellis hasn’t yet proven Syfovre can slow vision loss.
The retinal vasculitis cases in commercial use adds a new factor to doctors’ and patients’ risk-benefit calculations....
Strictly Confidential, No Obligation.
We turn next to this July 31, 2023 report about the Syfovre adverse reaction cases, "Updated: Apellis vows to be transparent about eye inflammation tied to Syfovre, but questions remain", published by EndPointsNews:
In Apellis’ second quarter earnings call, which immediately pivoted to Syfovre, execs vowed to handle the situation “with the utmost integrity and transparency.” But they also conceded that much remains unknown.
“We do not know the cause yet. And realistically, we may never identify a singular cause,” Apellis CEO Cedric Francois said. “What we do know, however, is that these events have been very rare and sporadic, and that zero events were reported in our clinical studies.”
He added later that so far, the company has only been able to rule out drug product and manufacturing, and the rest remains to be researched....
Retinal vasculitis is a “severe inflammatory event that can potentially lead to significant vision loss,” according to CMO Caroline Baumal.
Of the seven cases confirmed by Apellis, two have recovered their vision “nearly back to baseline,” she said on the call. Two more have severe vision loss that she said is not likely to resolve — and the other three confirmed cases are evolving.
Syfovre won FDA approval in February. So far, Apellis has distributed 68,000 commercial vials — with an estimate of 60,000 administered to patients — and given 23,000 injections in clinical trials.
There were intraocular inflammation cases in those trials; when the retinal vasculitis reports first appeared, Apellis said, it looked back at those cases. Both internal and external experts confirmed none were vasculitis events.
Finally, we point out "ASRS ReST Committee sheds light on timeline of Syfovre inflammation reports", which appeared July 29, 2023, on the Healio Ophthalmology website, from which we get a timeline of significant events related to these Syfovre adverse reaction cases:
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.
We will continue to watch for further updates from Apellis and the ASRS about Syfovre adverse reaction cases involving retinal vasculitis and other eye inflammation side effects in patients who have received Syfovre injections.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (Website content is written by Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Attorney Tom Lamb does all case reviews)