First, Novartis set up an internal review of Beovu vision-related side effects observed in the HAWK & HARRIER clinical trials, including rare post-marketing safety reports of vasculitis. In turn, new warnings for Beovu eye injections about retinal vasculitis and retinal vascular occlusion were added to the Beovu drug label. We take a closer look at these Beovu safety developments in this article.
We begin with this June 9, 2020, Ocular Surgery News report, “Review committee confirms safety signal of rare adverse events for Beovu”, from which we get these insights:
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….
The SRC compared the reported cases with events seen in the [Beovu] 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…
In connection with these post-marketing reports of Beovu vision-related side effects, on June 9, 2020, the FDA approved a Beovu label change which added warnings about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision. Following this FDA regulatory action, there have been new Beovu warnings added in Australia and Switzerland, with more drug safety regulatory actions expected in other countries going forward.
We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.[Read article in full at original source]