The United States Food and Drug Administration (FDA) has approved a label update for Beovu (brolucizumab) which includes safety information regarding retinal vasculitis and retinal vascular occlusion.
The following language has been added to the warnings and precautions section of Beovu’s label: “Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU injections. Patients should be instructed to report any change in vision without delay.”
The approval follows an announcement by Novartis that the company would pursue label updates for Beovu worldwide after reviewing post-marketing safety events. Novartis had found that retinal artery occlusion, vasculitis or severe vision loss occurred in 8.75 to 10.08 out of every 10,000 injections of Beovu during the time period spanning February 28 to March 27. As many as 4.03 per 10,000 injections in that time span caused severe vision loss.
“This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile,” said Novartis’ Marcia Kayath. “We remain grateful to all doctors who have taken the time to share their expertise and treatment experience to contribute to the collective understanding of these safety events. As we proceed to examine root causes and potential mitigation strategies, we will continue to communicate findings with transparency and urgency to regulatory bodies and healthcare providers.”
The label change is part of Novartis’ efforts to help physicians make good decisions about using Beovu. Novartis is also establishing an internal team collaborating with top global experts to examine potential treatment protocols, mitigation, risk factors and root causes.
“This broad-based coalition, which includes clinical trialists, epidemiologists, immunologists and uveitis specialists, is exploring innovative approaches to analyzing every aspect of available data, with the goal of providing physicians tools and information to safely and confidently treat their patients with Beovu,” said Ophthalmic Consultants of Boston’s Dr. Jeff Heier.
Beovu is a drug for the treatment of wet AMD. Wet AMD is a condition where new blood vessels grow in the choroid layer behind the retina. These vessels are weak and leak fluid, lipids and blood because they are weak. This leaking can cause scar tissue to form and can cause retinal cells to cease functioning.
Novartis said that reports about the conditions mentioned in the label update suggest the conditions can develop as soon as after the first or second injection of Beovu.