Syfovre Side Effects Linked to Eye Inflammation, Vision Loss Problems, Ophthalmologists Warn

A group of retinal specialists are warning that the side effects of Syfovre, a recently approved eye medication, may be linked to an increased risk of inflammation that could cause blindness in some cases.

Syfovre (Pegcetacoplan injection) was introduced by the drug maker Apellis Pharmaceuticals in February 2023, following approval by the FDA for treatment of geographic atrophy, which is a common form of vision loss. However, as the medication is increasingly used by patients, some are reporting serious problems from Syfovre, which may not have been adequately disclosed by the drug maker.

Earlier this month, the American Society of Retinal Specialists (ASRS) sent a letter to other healthcare providers, warning that Syfovre has been linked to at least six cases of occlusive retinal vasculitis, which is a serious condition that blocks the flow of blood to the retina and can lead to eye inflammation or complete loss of vision.

Syfovre Eye Inflammation Problems

According to a report by BioPharma Dive, the ASRS letter warns that eye inflammation side effects from Syfovre appear to occur within one to two weeks after a patient has received their first injection of the medication, which is typically administered every one to two months.

The ASRS noted that the Syfovre eye inflammation problems did not appear to be linked to a specific batch of the drug, and indicated it was unclear what was causing the side effects. However, the group of retinal specialists urged healthcare providers to be vigilant, provide close follow-up to patients who recently received a Syfovre injection, and urged doctors and patients to report any adverse events to the FDA.

Apellis officials have said they are in the process of investigating the incidents.

Similar Beovu Inflammation Warning

The ASRS issued a similar warning regarding the age-related macular degeneration drug Beovu in February 2020, after at least 14 cases of retinal vasculitis related to the Beovu eye medication.

As a result of the drug makers’ failure to warn about this potential side effect, a number Beovu lawsuits were pursued individuals who experienced problems.

Beovu (brolucizumab) was just approved just four years ago, as part of a class of medications known as anti-vascular endothelial growth factor therapy, or anti-VEGF. The FDA required a label update in 2020, in the wake of the ASRS warning, adding new information for users and the medical community about the risk of retinal vasculitis, which can result in blurry vision, visual floaters, dark spots, difficulty distinguishing colors and distorted images.

Due to the problems, some doctors decided to stop carrying the eye drug in their inventories and the FDA required the manufacturer to add new warnings about the link between Beovu and retinal vasculitis, and the importance of seeking immediate care from an ophthalmologist if a users’ eyes become red, sensitive to light, painful, or develop changes in vision.

The warning and label changes sparked a number of Beovu eye inflammation lawsuits, which have been filed in federal courts nationwide.