June 09, 2020
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Review committee confirms safety signal of rare adverse events for Beovu

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An external safety review committee evaluated post-marketing events and found a confirmed safety signal of rare adverse events that may result in severe vision loss after Beovu use.

Novartis received reports of vasculitis in 14 patients treated for wet age-related macular degeneration with Beovu (brolucizumab-dbll) since its approval by the FDA in October 2019. The company initiated an internal review of the case reports and established an external safety review committee (SRC) to provide an independent review of the cases, according to a press release.

The SRC compared the reported cases with events seen in the brolucizumab phase 3 HAWK and HARRIER trials. Using terminology defined by the SRC, Novartis confirmed a safety signal of rare adverse events termed as “retinal vasculitis” and/or “retinal vascular occlusion,” which typically occurred in the presence of intraocular inflammation. The adverse events may lead to severe vision loss, according to the release.

An unmasked review was conducted by the SRC on a subset of imaging data from the trials, which found some of the same adverse events. They occurred on a spectrum ranging from intraocular inflammation to vasculitis to occlusive events, sometimes resulting in vision loss.

According to post-marketing data, retinal vasculitis, retinal vascular occlusion or retinal vasculitis plus retinal vascular occlusion were evident in every 6.99 per 10,000 injections. Retinal vasculitis was evident in 1.69 per 10,000 injections, retinal vascular occlusion was evident in 1.57 per 10,000 injections, and retinal vasculitis plus retinal vascular occlusion was evident in 3.73 per 10,000 injections.

Physicians should look for signs of intraocular inflammation before injecting Beovu. If intraocular inflammation is evident, the injection should not be performed, and the inflammation should be treated according to medical practice, according to the release.

The U.S. prescribing information leaflet for Beovu says there is a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion, the release said.