As we have been reporting since July 2023, Syfovre’s side effects include 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 Syfovre’s side effects 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.
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