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Background

Following FDA approval of Beovu in October 2019, Novartis received reports of vasculitis, including retinal occlusive vasculitis. In addition, during February and March 2020, the American Society of Retinal Specialists (ASRS) shared updates with its membership regarding post-marketing case reports. Further information is available here.

Novartis 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 brolucizumab Phase III trials (HAWK & HARRIER). Using the terminology defined by the SRC, the Novartis review of post-marketing events concluded 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. Typically, these events occurred in the presence of intraocular inflammation (IOI).

The SRC also conducted an unmasked review of a subset of imaging data from HAWK & HARRIER and indicated that they saw some of the same adverse events in the trials. They found that these events occurred on a spectrum ranging from intraocular inflammation to vasculitis to occlusive events that sometimes resulted in vision loss.

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    Ongoing reviews and actions

    Novartis believes that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile. The following initiatives are ongoing:

    • To ensure information available for healthcare professionals and patients reflects our latest understanding of these adverse events, Novartis is continuing to update Beovu prescribing information worldwide.
    • The SRC has completed its review of the safety data from the HAWK & HARRIER trials and is expected to publish its independent assessment in a peer-reviewed journal in the coming months.