As we have been reporting since July 2023, Syfovre’s risks include serious eye side effects such as occlusive retinal vasculitis, a type of eye inflammation that blocks blood flow to the retina resulting in vision loss and potentially causing blindness. There have also been cases of non-occlusive retinal vasculitis and other types of eye inflammation.

In late June 2024, Europe’s drug regulator did not approve Syfovre for a second time, meaning that Syfovre is still unavailable in Europe. In the US, Syfovre was approved by the FDA in February 2023.

From this Fierce Pharma June 28, 2024 article, “EU’s drug regulator again rejects Apellis’ eye med….”, we get the latest on what is happening with Syfovre in Europe:

For the second time in six months, Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy (GA) caused by age-related macular degeneration….

“Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP said. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.”

“In terms of safety,” the CHMP continued, “regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision.”

In January of this year, the CHMP adopted its first negative opinion on Syfovre….

We have been monitoring this Syfovre drug safety issue since July 2023 on Drug Injury Watch, and these are the four most recent articles:

• Syfovre Retinal Vaso-occlusive Vasculitis Case Report Involving 78-year Old Woman With Vision Loss (4/24/2024)
• Syfovre Case Report: Occlusive Retinal Vasculitis Shortly After Patient’s First Syfovre Injection (3/6/2024)
• Syfovre Safety Issues Need More Attention Before This Relatively New Eye Drug Gets Widely Prescribed (12/27/2023)
• Syfovre Update: New Warnings About Retinal Vasculitis and/or Retinal Vascular Occlusion After Syfovre Injections (12/4/2023)

We continue to investigate possible Syfovre drug injury lawsuits for patients who developed retinal vasculitis or retinal vascular occlusion with resulting vision loss or blindness after their Syfovre injection.

[Read the article in full at source]

---

Syfovre

Free Case Evaluation

Strictly Confidential, No Obligation

We have some new information about Syfovre eye injections adverse reactions causing vision loss and blindness from Apellis Pharmaceuticals and the American Society of Retina Specialists (ASRS).

Apellis said that it has confirmed seven cases of Syfovre eye injections adverse reactions. More specifically, these Syfovre vision loss cases involve a type of eye inflammation called retinal vasculitis. Four Syfovre patients have developed occlusive retinal vasculitis, a possibly blinding condition in which blood flow to the retina is blocked.

The ASRS shared a timeline of events related to these cases of Syfovre eye injections adverse reactions, as outlined below:

• July 3, 2023: The first report of panuveitis with retinal occlusive vasculitis was received by the ASRS Research and Safety in Therapeutics (ReST) Committee.
• July 5, 2023: ReST contacted Apellis to discuss safety concerns arising from this first Syfovre vision loss case.
• July 6-12, 2023: The ASRS received six additional reports of Syfovre eye injections adverse reactions in patients.
• July 12, 2023: Apellis and the ASRS Research and Safety in Therapeutics (ReST) Committee met to discuss severe intraocular inflammation and cases of vasculitis in patients who had received Syfovre eye injections.
• July 15, 2023: The ASRS Executive Committee unanimously approved the Syfovre safety concerns “communication”, which was agreed to by Apellis and sent to ASRS members that same day.

It has been reported by medical news sources that as of late July 2023, Apellis does not know the cause, yet, for these seven cases of Syfovre eye injections adverse reactions. Further, Apellis has said that so far the company has only been able to rule out drug product quality and manufacturing issues.

As such, other possible causes for these Syfovre vision loss cases involving retinal vasculitis remain to be researched.

We are investigating Syfovre vision loss cases as drug injury lawsuits against Apellis for patients who developed occlusive retinal vasculitis or eye inflammation after receiving a Syfovre eye injection.

[Read article in full at original source]

---

Syfovre

Free Case Evaluation

Strictly Confidential, No Obligation