The FDA recently approved an updated label for Beovu (Novartis) that now includes information about the potential risks of retinal vasculitis and retinal vascular occlusion, according to a company statement. The change comes after the American Society of Retina Specialists warned its member of 14 reported cases of vasculitis—11 of which were occlusive retinal vasculitis—since the drug’s approval in October 2019. After an internal review, Novartis confirmed a safety signal of rare adverse events for retinal vasculitis and retinal vascular occlusion.
The updated “Warnings and Precautions” section of the label will include a subsection on retinal vasculitis and retinal vascular occlusion, which are “part of a spectrum of intraocular inflammation rates” from the Phase III HAWK and HARRIER trials, according to the company.
These trials, which led to the medication’s approval, showed that Beovu was noninferior to aflibercept in best-corrected visual acuity change from baseline at 48 weeks. The trials also revealed a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion.
Beovu’s complication rates are similar to those reported by other anti-VEGF agents, according to Mohammad Rafieetary, OD, who is a consultative optometrist at the Charles Retina Institute in Germantown, TN, who adds that all anti-VEGF agents come with potential risks.
|Dugel PU, Koh, Ogura Y, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.|