The Food and Drug Administration (FDA) has approved updated labeling for Beovu® (brolucizumab; Novartis) to include additional safety information regarding the risk of retinal vasculitis and retinal vascular occlusion.
Beovu received FDA approval in October 2019 for the treatment of wet age-related macular degeneration (wet AMD). The Warnings and Precautions section has been updated with the addition of a subsection regarding retinal vasculitis and/or retinal vascular occlusion as part of a spectrum of intraocular inflammation observed in the phase 3 HAWK & HARRIER trials.
The update is based on a recent internal review conducted by Novartis of adverse events observed in the HAWK & HARRIER clinical trials, including rare postmarketing safety reports of vasculitis. According to Novartis, a review of these postmarketing events concluded that “there is a confirmed safety signal of rare adverse events termed as ‘retinal vasculitis’ and/or ‘retinal vascular occlusion’ that may result in severe vision loss.” These events typically occurred when intraocular inflammation was present.
When compared with select intraocular inflammation events seen in the phase 3 trials, the Safety Review Committee (SRC) established by the Company found that cases similar to the postmarketing reports were present in these trials. Despite the risk of vision loss associated with these adverse events, the SRC noted that the overall rate of vision loss between brolucizumab and aflibercept arms was similar.
“This label update provides clinicians with important information to guide treatment decisions,” said said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. “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.”
Treatment with Beovu should be withheld if patients report clinical signs of intraocular inflammation or if changes in vision occur after Beovu injection; appropriate diagnostic evaluation should be performed and symptoms should be treated as clinically indicated. Patients should be advised to seek immediate care if the eye becomes red, sensitive to light, painful or if there is a change in vision in the days following Beovu administration. Based on postmarketing case reports, most adverse events (ie, blurry vision or increase in floaters) presented within 1 to 2 weeks of treatment initiation after the first or second Beovu injection.
For more information visit novartis.com.