American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre
(Posted by Tom Lamb at Drug Injury Watch)
UPDATE: From this February 28, 2024, Fierce Pharma news report, "Apellis cites current challenges with Syfovre launch but bright prospects in the long term", we get the most recent explanation from Apellis Pharmaceuticals about the cause of Syfovre eye-related side effects:
As for Syfovre’s safety issue — which Apellis originally speculated was a needle problem for the injected drug — the company now “firmly” believes it is caused by a pre-existing allergy toward polyethylene glycol, Francois said. The incidence of users developing vasculitis remains at .01% per injection, the company said. [Emphasis added.]
(2/28/24)
On July 15, 2023, the American Society of Retinal Specialists (ASRS) issued this letter to its members, "ASRS Research and Safety in Therapeutics (REST) Committee Update on Adverse Events Reports Associated with Syfovre", warning about the Syfovre side effects eye inflammation and occlusive retinal vasculitis in patients who used this injection treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Occlusive retinal vasculitis is a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and could potentially cause blindness.
The ASRS July 2023 letter about these Syfovre side effects pointed out reported cases of eye inflammation and six reports of occlusive retinal vasculitis, noting that these vision problems began one to two weeks after a patient’s first Syfovre (pegcetacoplan) injection.
From this news report, "Apellis rocked by retinal vasculitis reports linked to Syfovre", published in the July 18, 2023 edition of ThePharmaLetter, we get these details about this new and still evolving Syfovre side effects situation:
According to Apellis, the company has reviewed the retinal vasculitis events with the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics Committee.
All the events were observed after the first injection of Syfovre, between seven to 13 days after drug administration, and with no specific lots implicated.
Upon review with external experts, two of the events were confirmed as occlusive, one was confirmed as non-occlusive, and the remaining three were undetermined based on limited information and lack of imaging. The cause of these events is unclear, and outcomes in these patients are still evolving....
In a filing to the US Securities and Exchange Commission, Apellis explained: “The reported vasculitis events have occurred at an estimated rate of approximately 1 in 10,000 injections, or 0.01% per injection. To date, approximately 60,000 vials of Syfovre have been distributed since the FDA approval on February 17, 2023, including commercial vials shipped to physician practices as well as sample vials delivered. In addition, there were zero events of retinal vasculitis reported in the clinical trials, reflecting more than 23,000 injections to date.”
Following the review with the FDA, no action is currently planned, but Apellis is continuing to conduct a thorough investigation of the events alongside the ReST Committee and several external specialists.
__________________________________________________________________
Syfovre
Free Case Evaluation
Strictly Confidential, No Obligation.
__________________________________________________________________
Back in 2020, the ASRS alerted its member doctors about 14 cases of retinal vasculitis in patients after using Beovu, soon after that wet age-related macular degeneration drug from Novartis was approved by the FDA.
During the past few years, our law firm has handled Beovu lawsuits that involved retinal vasculitis causing vision loss and blindness. Those Beovu cases were filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about these Beovu side effects in a timely manner. We point out that the first three Beovu vision loss lawsuits filed in the US were for clients of our law firm.
Currently, we are investigating Syfovre drug injury lawsuits against Apellis Pharmaceuticals, Inc., the drug company responsible for Syfovre, for patients who have been diagnosed with retinal vasculitis or some other type of eye inflammation after receiving a Syfovre injection, causing vision loss or blindness.
If you or someone you know has a possible Syfovre drug injury lawsuit, we encourage you to submit a Syfovre Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb. Either way, you will get Mr. Lamb’s impressions about your Syfovre side effects case based on his more than 20 years of experience handling drug injury lawsuits.
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)