Novartis recently reported initial findings from a coalition convened to answer key questions related to treatment with Beovu® (brolucizumab) for adults with wet age-related macular degeneration (AMD). Analyses of US real-world and Phase III data identified baseline patient characteristics potentially associated with the incidence of inflammation-related adverse events that may occur following treatment with Beovu. These findings were presented last week at the American Academy of Ophthalmology (AAO) 2020 Annual Meeting.
The analysis pulled data from the IRIS Registry, which included 12,000 patients treated with Beovu. The highest observed risk for experiencing retinal vasculitis (RV) and/or retinal vascular occlusion (RO) in the six months after the first treatment with Beovu was prior intraocular inflammation (IOI) and/or prior RO in the 12 months before the first Beovu injection. Against an observed overall RV/RO risk rate of 0.46% for all Beovu-treated patients in the registry, this increased to 3.97% in individuals with prior IOI and/or RO.
“We are pleased to share these findings that underscore the importance of carefully examining a patient for active ocular inflammation before injecting Beovu and throughout the course of treatment,” said Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. “Even with the great advancements made in treating wet AMD, data shows 50% of patients have unresolved fluid and a third require monthly injections, highlighting the persistent unmet need that Beovu may help address."
In a post-hoc unmasked assessment of the Phase III HAWK and HARRIER data, there was an observed trend toward increased incidence of RV/RO in patients with treatment emergent (boosted/induced) anti-drug antibodies (ADAs). Further analyses of the data presented and additional data collection are ongoing.
Novartis has five presentations at the congress including results from a post-hoc HAWK and HARRIER analysis showing Beovu is associated with greater and sustained reduction in Pigment Epithelial Detachments and Subretinal Hyper-reflective Material compared with aflibercept. Novartis also sponsored a symposium including description of US real-world wet AMD patient case studies with Beovu. Novartis has a comprehensive program of work underway examining the root cause and potential risk factors for these events, as well as identifying mitigation strategies and treatment protocols.
Beovu is now approved in more than 50 countries, including in the US, EU, UK, Japan, Canada and Australia, based on the results of the HAWK and HARRIER clinical trials.
Full press release from Novartis.