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Amid increasing concerns about the risk of severe vision problems from Beovu, which required a warning label update only a few months after the treatment for wet age-related macular degeneration (AMD) was introduced, a new case study suggests that the risk may result from a delayed hypersentivity reaction among some users who receive the injection.
Beovu (brolucizumab) was just approved for sale in the United States in October 2019, as a treatment for wet age-related macular degeneration. It belongs to a class of drugs known as anti-vascular endothelial growth factor therapy, or anti-VEGF. However, side effects of Beovu have been linked to reports of a severe form of eye inflammation, known as retinal vasculitis.
In February 2020, researchers with the American Society of Retina Specialists first raised concerns about the Beovu vision problems, warning members the group was aware of at least 14 cases of retinal vasculitis, 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.
Delayed Problems From Beovu Injection
In findings published earlier this month in the American Journal of Ophthalmology Case Reports, researchers with Bascom Palmer Eye Institute and Retina Associates, both in Florida, describe an incident involving a 76-year-old woman who suffered pain, decreased vision and floaters in her vision following her third Beovu injection.
After experiencing the vision problems from Beovu, she was switched to a different eye drug; Lucentis. However, the case report indicates that she continued to suffer progressive problems with her vision, including uveitis, iritis, vascular sheathing, and decreased vision. A number of other treatments failed to work, and infections were ruled out as possible causes of the complications.
Doctors concluded that the woman experienced delayed hypersensitivity to Beovu, leading to speculation that similar issues may be at play in other cases of Beovu-related retinal vasculitis as well.
“Treatment with brolucizumab can result in intraocular inflammation and retinal vasculitis likely due to a delayed hypersensitivity reaction to the drug, supported by cytopathologic analysis of a vitreous sample,” the doctors concluded. “We demonstrate a case where retreatment with an alternative anti-VEGF agent resulted in worsening vision and vasculitis.”
The implication of her conditioning worsening on Lucentis may suggest the problems are class-wide, though prior reports suggest that only Beovu side effects may be linked to the complications.
Novartis, who is conducting an ongoing review of the drug, indicates its findings suggest most cases of retinal vasculitis seem to occur after the first or second Beovu injection, and the company now urges patients to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful or develop changes in vision. However, it faces mounting criticism for failing to include similar warnings when Beovu was first introduced.
As a result of the drug makers failure to adequately disclose the potential vision risks to users, doctors and regulators, a number of consumers diagnosed with retinal vasculitis or retinal vascular occlusion are now investigating potential Beovu lawsuits.