Reports and opinions keep pouring in about Novartis’ Beovu® (brolucizumab), meant to treat wet or neovascular age-related macular degeneration (nAMD). In February, the American Society of Retina Specialists (ASRS) noted a risk of intraocular inflammation and retinal vasculitis associated with the drug; more concerning was that 11 of the 14 cases of vasculitis were occlusive retinal vasculitis, which can lead to vision loss. The drug’s main appeal is that it reduces the rate of injection to once a quarter following the initiation of treatment.
Novartis backed these findings in April, noting a “confirmed safety signal of rare adverse events of retinal vasculitis and/ or retinal vascular occlusion that may result in severe vision loss.” Novartis’ safety review committee (SRC) noted a 3.3% rate of retinal vasculitis in study patients who had been treated with Beovu. Most of the patients (74%) experienced symptoms within six months of the treatment, though some (12%) experienced it as late as 12-18 months afterwards. According to an ASRS report, the earlier events were associated more frequently with moderate or severe vision loss.
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Beovu: What’s the latest with the ophthalmic community’s concerns?