Novartis Maintains Beovu Eye Inflammation Rates Low, Defending Safety of New Drug

Following an internal review that examined recent concerns raised by retinal specialists about the risk of eye inflammation from Beovu, Novartis indicates that the rates of problems with the new-generation eye drug are low.

The American Society of Retina Specialists (ASRS) raised concerns about problems with Beovu eye inflammation last month, warning members that the group was aware of at least 14 cases of retinal vasculitis, 11 of which are of a type that can lead to vision loss, known as occlusive retinal vasculitis. Some eye doctors have since decided to stop carrying Beovu in their inventory, and Novartis indicated that it would launch an internal review.

According to a press release issued on March 2, the drug maker is defending the safety of Beovu, indicating that its own review shows that the rate of cases of retinal vasculitis appear to be below that indicated on the drug’s warning label.

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Side effects of Beovu have been linked to reports of severe and permanent vision problems, known as retinal vasculitis.

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Beovu (brolucizumab) was approved just a few months ago in October 2019, for the treatment of wet age-related macular degeneration. It belongs to a class of drugs known as anti-vascular endothelial growth factor therapy, or anti-VEGF. However, it is the only drug of this class linked to incidents of retinal vasculitis; a form of eye inflammation.

The announcement by Novartis that the Beovu eye inflammation rates are low comes only days after the review was initiated.

“The prescribing information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion,” Novartis states in the press release. “We believe the incidence of these events remains consistent with or below the package insert.”

Novartis says it is still conducting a quality review and evaluating every case. The company indicates that its findings so far suggest that most cases of retinal vasculitis seem to occur after the first or second Beovu injection. Affected patients report vision changes such as floaters or blurry vision within one or two weeks of the injections.

The company is urging patients to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful, or develop changes in vision.

Novartis indicates that, as of March 2, more than 57,000 Beovu vials have been distributed to doctors nationwide.

Wet age-related macular degeneration affects about 20 million people worldwide. It is a chronic eye disorder which can caused blurred vision or blind spots. It usually occurs when abnormal blood vessels leak into the macula. The degeneration can be stopped, and sometimes vision loss can be reversed, if treated early enough.

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