If you used the prescription eye injection Syfovre® to treat geographic atrophy and later developed retinal vasculitis or retinal vascular occlusion, you may be owed compensation. Read on to learn more about Syfovre, its adverse effects, and who can join the Syfovre lawsuit.
What is Syfovre and who takes it?
Syfovre is a prescription drug approved by the FDA to slow the progression of geographic atrophy (GA) due to age-related macular degeneration (AMD). Age-related macular degeneration is a problem with the retina of the eye which develops when the macula, the part of the retina responsible for central vision, is damaged. People diagnosed with AMD slowly lose their central vision. It’s the leading cause of vision loss and blindness for Americans 65 and older.
Geographic atrophy is an advanced form of AMD that is characterized by atrophic lesions that grow in the retina and progressively expand, covering the macula and the fovea (the center of the macula), leading to irreversible vision loss.
Syfovre, a name brand for pegcetacoplan injections developed by Apellis Pharmaceuticals, is one of the first FDA-approved drugs of its kind. It’s administered by a doctor intraocularly, or through the eye, once every 25 to 60 days, and it works by regulating an overactivated part of the eye’s immune system to slow the progression of GA. Early clinical trials showed that monthly administration of Syfovre slowed the rate of GA lesion growth by 18-22% over two years.
More recent studies, however, have found that patients taking Syfovre are at higher risk of developing retinal vasculitis and retinal vascular occlusion, two rare but serious conditions that can cause irreversible vision loss or blindness.
What are retinal vasculitis and retinal vascular occlusion?
Retinal vasculitis is a disease that causes inflammation of the retinal vessels. Although it may develop in patients without a known cause, it is often associated with chronic inflammatory diseases such as lupus, Crohn’s disease, rheumatoid arthritis, and sarcoidosis, among others. Retinal vasculitis can lead to vision loss and blindness. Retinal vasculitis can also lead to a type of blockage called vascular occlusion.
Two common types of retinal vascular occlusions include retinal artery occlusions (RAO) and retinal vein occlusions (RVO). RAO occurs when one of the vessels carrying blood to the retina gets blocked, while RVO is when one of the vessels carrying blood away from the retina becomes blocked. Both conditions develop suddenly and painlessly and can cause permanent loss of eyesight in all or part of one eye.
Can Syfovre cause retinal vasculitis?
Results from recent real-world studies have revealed that a small number of patients treated with Syfovre developed retinal vasculitis. Studies presented at the 2024 American Society of Retina Specialists (ASRS) meeting put the risk of developing retinal vasculitis at one in every 1,330 Syfovre patients.
Another study observed a 78-year-old woman who complained of eyelid swelling, conjunctival injection (inflammation and dilation of blood vessels in the eye), loss of vision, and eye discomfort less than two weeks after receiving a pegcetacoplan injection for GA. Further examination of the patient found decreased visual acuity, hemorrhages throughout the retina, and signs of retinal vasculitis.
Additionally, drug regulators in Europe have rejected Apellis Pharmaceuticals’ attempts to sell the drug to the European market, arguing that Syfovre “did not lead to meaningful benefits for patients” and that regular injections of the drug carries a “significant risk” of adverse events.
What is the Syfovre retinal vasculitis lawsuit?
Along with claims that Syfovre injections can cause serious retinal conditions, Apellis Pharmaceuticals is also suspected of not taking the appropriate steps to inform the public of a potentially harmful recall to their products.
In August of 2023, Apellis issued a Class 2 Device Recall on their Syfovre injection kits. According to the FDA, the recall was prompted after “non-preferred characteristics” were found in some of the 19-gauge x 1” inch filtered needles included in some of the kits.
The affected Syfovre needles were found to have issues with tight packaging, exposed filter material, and weak filter seams. These problems could potentially allow small particles from the device to enter the eye upon injection.
Lawsuits against Apellis Pharmaceuticals allege that the company failed to adequately warn about the elevated risk of retinal vasculitis and retinal vascular occlusion. The lawsuits also state they were not transparent about defects in the way the product was manufactured. Some cases even claim the pharmaceutical company was negligent in its duty to ensure the safety of its product.
Syfovre patients have been seeking representation and filing lawsuits for retinal vasculitis that may be linked to their pegcetacoplan injections.
Get help with your Syfovre lawsuit
If you used Syfovre pegcetacoplan injections to treat geographic atrophy and were later diagnosed with retinal vascular occlusion or retinal vasculitis, you may be able to join the Syfovre lawsuit. You may be owed compensation from Apellis Pharmaceuticals, the manufacturer of these products, for failing to warn users of the product defects and risk of retinal vasculitis or retinal vascular occlusion. Fill out the form below or call today to contact the team at Woods and Woods for a free case evaluation.
Syfovre lawsuit
Syfovre® is a registered trademark of Apellis Pharmaceuticals, Inc. The trademarks listed are used here only for the purpose of identifying the products in question. Woods and Woods, LLC is not affiliated with, sponsored by, or associated with the U.S. Food & Drug Administration or Apellis Pharmaceuticals, Inc.
