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According to allegations raised in a recently filed product liability lawsuit, side effects of a Beovu eye injection provided for treatment of wet age-related macular degeneration left a Nebraska woman with severe retina damage and permanent vision problems.
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, it has already been linked to reports of a severe form of eye inflammation, known as retinal vasculitis, which led the FDA to announce updated warnings last year.
In a complaint (PDF) filed in the U.S. District Court for the District of Nebraska on January 27, Constance Sundell joins a growing number of users alleging that the drug makers’ failed to properly test the medication and provided inadequate warnings at the time Beovu was introduced in October 2019.
Sundell presents claims against Novartis and Alcon Research, alleging the manufacturers knew or should have known about the Beovu eye injection risks, yet provided false and misleading information about the safety of the drug as a treatment for wet age-related macular degeneration.
“Defendants failed to warn physicians and the public about Beovu’s propensity to cause vision related adverse events including, but not limited to, ocular inflammation, retinal vasculitis, retinal vascular occlusion, and other serious and permanent eye injuries,” Sundell’s lawsuit states. “Consumers and physicians alike have been misled about Beovu’s safety and efficacy, and as a result consumers, including Plaintiff, have suffered serious and permanent eye injuries including ocular inflammation, retinal vasculitis, retinal vascular occlusion, and other serious eye injuries.”
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.