At the 2024 meeting of the American Society of Retina Specialists in Stockholm, Sweden, Arshad Khanani MD, MA, FASRS, presented findings from the RHONE-X trial of faricimab (Vabysmo; Genentech) in patients with diabetic macular edema (DME). This is the first time the data, which evaluated long-term safety and efficacy of faricimab over 4 years, were reported.
RHONE-X was a 2-year, phase 3, multicenter, open-label extension trial that enrolled 1,474 patients with DME who had completed 1 of the 2-year parent trials, YOSEMITE or RHINE. During RHONE-X, all participants were treated with faricimab 6 mg on a personalized treat-and-extend regimen, where the time between treatments could be increased up to 16 weeks based on prespecified retinal fluid and visual acuity criteria. The first 16 weeks of RHONE-X had masked monthly visits, followed by an open-label period where patients only attended study visits per their T&E interval. Overall, 81.7% (1204/1474) of patients enrolled in RHONE-X completed the trial.
Results of the exploratory analysis showed that at the end of 4 years, nearly 80% of participants treated with faricimab had extended their treatment intervals to greater than 12 weeks. Robust vision gains and improved central subfield thickness (CST) achieved during YOSEMITE or RHINE were maintained in RHONE-X. At the end of RHONE-X, more than 90% of patients achieved absence of DME (CST <325 μm), regardless of the original treatment assignment.
Faricimab also was well tolerated throughout RHONE-X, as demonstrated by the low rate of study discontinuation (1.4%) due to adverse events (AEs). The nature of AEs was consistent with the safety profile of the parent trials. Rates of intraocular inflammation AEs were low (1.3%), and there were no cases of retinal vasculitis or retinal occlusive vasculitis.
“These four-year data build on our pivotal studies and reinforce Vabysmo’s potential to become standard of care treatment for diabetic macular edema (DME), which affects 29 million people worldwide,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, in a press release.
