Novartis in Process of Conducting a Comprehensive Product Review of Beovu

The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.

In a March 2, 2020 press release, Novartis provided an update on the use and safety of Beovu in patients with wet age-related macular degeneration (AMD), which are believed to be consistent with the current package insert of the therapy. At the moment, the prescribing information leaflet for Beovu in the United States specifies that there is a 4% risk of intraocular inflammation and a 1% rate of retinal artery occlusion.

Additionally, Novartis has revealed that it is conducting a comprehensive product quality review and actively evaluating every case as part of the safety surveillance program. As well as working closely with reporting physicians and retina specialists, Novartis is also working with the Data Monitoring Committee for the continuing global clinical trials and have also employed an external safety review committee for the evaluation and advisement on post-marketing cases.

Based on the preliminary observations, which include presentation of adverse events after the first or second injection of Beovu with patients reporting visual changes within one or two weeks of treatment, Novartis has reminded physicians to advise patients on the potential symptoms and to seek immediate care from an ophthalmologist if any symptoms do present. More information can be found on Novartis’ website.

Source: Novartis