Beovu Injection Caused Retinal Vasculitis and Other Vision Side Effects, Lawsuit Alleges

A Maryland man has filed a product liability lawsuit alleging he developed retinal vasculitis and other vision problems that were caused by side effects of a Beovu injection received for treatment of age-related macular degeneration.

Beovu (brolucizumab) was just approved just three years 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 in 2020, adding new 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.

In a complaint (PDF) filed against Novartis Pharmaceuticals on December 13, Howard Noll indicates that he experienced vision side effects after receiving the Beovu injection months before the warnings were added, indicating that the drug maker misrepresented the safety the age-related macular degeneration drug and failed to warn the medical community and patients about the risk of developing retinal vasculitis.

The case joins a number of other similar Beovu lawsuits filed over the past few years, alleging that users may have avoided permanent vision problems if earlier information and warnings had been provided about long-term eye damage that may result from the injection.

Noll indicates that he was prescribed and injected with Beovu in January 2020, claiming that he developed a condition known as retinal vasculitis that was directly caused by the Beovu injection.

Retinal vasculitis is caused by inflammation in the blood vessels of the retina, which can cause retinal vascular occlusion and retinal artery occlusion. These can lead to severe and permanent vision loss.

“Retinal vasculitis and retinal vascular occlusion are injuries unique to Beovu use. These injuries have been widely reported in patients taking Beovu, but are not considered to be a risk with other VEGF inhibitors,” the lawsuit states. “On January 23, 2020, American Society of Retina Specialists (“ASRS”) issued an alert to its members that it had already begun to receive physician reports of intraocular inflammation caused by the use of Beovu.”

However, the drug maker did not update the Beovu warning label until June 2020, urging doctors to instruct patients to report any changes in vision from Beovu, to avoid delays in treating the condition, which can result in permanent damage.

Beovu Eye Injury Side Effects

The concerns about Beovu injection retinal risks emerged after independent researchers with the American Society of Retina Specialists raised concerns about vision risks associated with the medication.

In February 2020, the group sent a 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 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.

2022 Beovu Lawsuit Update

Although common questions of fact and law have been raised in Beovu lawsuits filed against Novartis throughout the federal court system, there is not currently any centralized MDL, and coordinated pretrial proceedings have not been formally established. Therefore, cases are pending in various different U.S. District Courts nationwide before different federal judges.

Given the limited number of users prior to the Beovu warning label update in June 2020, the size and scope of the litigation is expected to be limited to only a few hundred potential claims that may be brought nationwide.

As cases continue to move forward and Beovu trials are scheduled, they will be closely watched by lawyers involved in the litigation and may have an impact on eventual Beovu settlement negotiations that may be reached to avoid each individual claim going before a jury in the coming years.