Retinal Vasculitis After Syfovre Injections: Etiology is Still Unknown and Incidence Rate Remains Unclear
(Posted by Tom Lamb at Drug Injury Watch)
Syfovre (pegcetacoplan) was approved by the FDA in February 2023 as an eye injection to treat geographic atrophy (GA), a relatively rare condition secondary to age-related macular degeneration. Beginning in April 2023, there have been reports of Syfovre eye injury cases, including (1) retinal vasculitis resulting in significant vision loss, and (2) intraocular inflammation without retinal vascular involvement.
Syfovre eye injury cases for patients with vision loss due to retinal vasculitis have received the most attention from retina specialists investigating this Syfovre drug safety issue. As of the beginning of April 2024, those retina specialists seem to agree that both the etiology and the incidence rate of retinal vasculitis after Syfovre injections remain uncertain.
Over time, Apellis Pharmaceuticals, the drug company responsible for Syfovre, has offered information about the number of Syfovre vials distributed for use and the percentage per Syfovre injection of patients who have developed vasculitis. In addition, Apellis has put out some possible explanations for these Syfovre eye injury cases involving vision loss. Originally, Apellis speculated that certain needles used for Syfovre injections were the cause, but then some months later said a pre-existing allergy toward polyethylene glycol caused it.
There are at least two difficulties when determining the number of Syfovre eye injury cases involving retinal vasculitis that have occurred to date.
First, it is generally acknowledged that voluntary reporting of prescription drug adverse events is inherently subject to underreporting. Therefore, it is likely that some Syfovre retinal vasculitis cases have not been reported to the FDA, Apellis, or retina specialists.
Second, some Syfovre patients who developed “mild” retinal vasculitis might not have been identified because they did not receive a careful dilated fundus examination or fluorescein angiography (FA). As such, these patients who might have developed retinal vasculitis are not counted by the Syfovre injections incidence rate.
We have been monitoring this Syfovre drug safety issue and continue to report significant developments on Drug Injury Watch. We list our three most recent articles if you want to learn more:
- 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 are investigating Syfovre eye injury cases for patients who suffered vision loss due to retinal vasculitis after receiving Syfovre injections. These Syfovre lawsuits would be filed against Apellis Pharmaceuticals, not the patients’ ophthalmologists or retina specialists.
If we can assist you or someone you know, our Syfovre Case Evaluation Form is available online, or you can call us at (800) 426-9535 to speak about a possible Syfovre eye injury case.
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