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A California man indicates the side effects of Beovu left him with a permanent eye injury and vision problems, after receiving the injection for treatment of wet macular degeneration.
The complaint (PDF) was filed by Raymond Rayes in the U.S. District Court for the Central District of California on February 3, indicating that Novartis and Alcon Research misrepresented the safety and effectiveness of Beovu, which has been linked to a host of serious eye injuries reported among individuals nationwide.
Beovu (brolucizumab) was just approved less than 18 months ago, as part of a class of medications known as anti-vascular endothelial growth factor therapy, or anti-VEGF. However, the FDA required a warning update last year, adding information for users and the medical community about the risk of severe eye inflammation, known as retinal vasculitis, which can result in blurry vision, visual floaters, dark spots, difficulty distinguishing colors and distorted images.
Rayes indicates he received the wet macular degeneration drug, and experienced ocular inflammation, retinal vasculitis, and retinal vascular occlusion, which is a more severe issue that occurs when the retinal artery becomes blocked, resulting in permanent eye dmaage.
“Defendants misrepresented that Beovu was a safe and effective treatment for age-related macular degeneration when in fact the drug causes serious medical problems including intraocular inflammation, retinal vasculitis, retinal vascular occlusion, and other serious vision problems,” the lawsuit states.
The case joins a growing number of Beovu lawsuits now being pursued by former users nationwide, which have all emerged since researchers with the American Society of Retina Specialists first raised concerns about vision risks associated with the medication early last year.
In February 2020, the group sent warning to members about at least 14 cases of retinal vasculitis from Beovu, involving inflammation of the branches of the retinal artery. At least 11 of those cases involved a more severe instance of the inflammation known as a retinal vascular occlusion, where the vein becomes blocked and may result in permanent vision loss.
Due to the problems, some doctors have 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 in June 2020. However, consumers and the medical community are still trying to understand the risk.
While Novartis initially marketed and sold the drug for months without warnings about the Beovu retina problems, a warning update in June 2020 added new information to the drug label. The company is now urging patients to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful, or develop changes in vision.