There have been reports of severe vision loss associated with Beovu injections as well as cases of vasculitis linked to Beovu.
In March 2020 Novartis stated that the current Beovu Prescribing Information document sufficiently addressed Beovu risks of intraocular inflammation and retinal artery occlusion.
However, Novartis recently said that it will work with FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu vision-related side effects, according to an April 2020 news report.
For an April 9, 2020 BioPharma Dive news report about Beovu, “Eye drug side effects are real, Novartis confirms in new warning”, reporter Jonathan Gardner included this observation by RBC Capital Markets analyst Kennen MacKay:
RBC’s MacKay wrote that the cases of severe vision loss and vasculitis should draw the most scrutiny from the FDA, because they haven’t been reported with Eylea and other drugs using the same biological pathway such as Roche and Novartis’ Lucentis and Roche’s Avastin, which is used off-label.
It was during February 2020 that the first news reports about the Beovu risks of intraocular inflammation and retinal artery occlusion surfaced, which we presented in this earlier article, “Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug”.
We are investigating cases of severe vision loss associated with Beovu and cases of vasculitis linked to Beovu as possible drug injury lawsuits that could be filed against Novartis.[Read article in full at original source]