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According to a safety review conducted by Novartis, patients with prior eye inflammation problems may face a higher risk of experiencing severe and vision threatening side effects from Beovu, known as retinal vasculitis or retinal vascular occlusion.
Beovu (brolucizumab) was just introduced by Novartis in October 2019, for the treatment of wet age-related macular degeneration. However, only a few months later it was linked to a risk of serious eye problems that may result in blurry or distorted vision, including blindness.
Retinal vasculitis is a form of eye inflammation impacting branches of the retinal artery. A retinal vascular occlusion occurs when the vein becomes blocked, which may result in complete loss of vision and permanent blindness caused by damage to the retina.
The American Society of Retina Specialists (ASRS) first raised concerns about the problems with Beovu eye inflammation in February 2020, warning members of the group it was aware of at least 14 cases of retinal vasculitis, 11 of which reportedly involved an occlusion. In response to the Beovu risk, some eye doctors decided to stop carrying the AMD injection in their inventory, and Novartis indicated it would launch an internal review.
On November 13, Novartis issued a press release outlining the initial findings on patient characteristics and the likelihood of developing vision problems while taking Beovu.
The company’s researchers analyzed data from the IRIS Registry, which included data on 12,000 patients treated with Beovu. According to the findings, patients who appeared to have the highest risk of experiencing retinal vasculitis (RV) and/or retinal vascular occlusion (RO) within six months after starting Beovu treatment were those who had experienced intraocular inflammation or RO in the previous year.
Novartis’ findings indicate there was nearly a 4% chance of this category of patient experiencing retinal problems on Beovu, compared to just a 0.46% chance among other users.
“We are pleased to share these findings that underscore the importance of carefully examining a patient for active ocular inflammation before injecting Beovu and throughout the course of treatment,” Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer at Novartis Pharmaceuticals, said in the press release. “Even with the great advancements made in treating wet AMD, data shows 50% of patients have unresolved fluid and a third require monthly injections, highlighting the persistent unmet need that Beovu may help address.”
The findings are being presented this week at the American Academy of Ophthalmology (AAO) 2020 Annual Meeting in Las Vegas, Nevada.
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.
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.
A number of former users who experienced vision problems from Beovu are now reviewing potential product liability lawsuits against the manufacturer, alleging Novartis placed the desire for profits before consumer safety by filing to disclose the risk of retinal vascular occlusion when the drug was introduced.