Beovu (brolucizumab) for wet AMD is the newest anti-VEGF drug on the market. It has been shown to be an effective and long-lasting inhibitor of blood vessel development (neovascularization) in the retina. The drug’s manufacturer has, however, been recently investigating incidences of severe intraocular inflammation (vasculitis) and retinal artery occlusion that were reported after their product was approved in October 2019.
Beginning in March 2020, a retrospective analysis of retinal vasculitis in 12 female patients from 10 U.S. centers was conducted. They found that the patients’ visual acuity had decreased significantly over a period of around 25 days following injection. Until a cause for the problem is determined, retinal specialists are being advised to avoid using Beovu. Those who wish to continue are encouraged to check for any sign of active inflammation in the patient’s eye before proceeding.
Novartis, makers of Beovu, initiated its own internal review of these post-marketing safety case reports, including the establishment of an external safety review committee (SRC) to provide an independent, objective review of these cases and a comparison with events seen in the Phase III trials (HAWK & HARRIER). Novartis has also convened a fully dedicated team collaborating with top global external experts, leveraging the collective multidisciplinary expertise to examine the root causes, potential risk factors and mitigation of these adverse events. The latest updates can be found at brolucizumab.info.