RHONE-X: 90% of Patients Treated with Faricimab Free from DME at 4 Years

New data presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting is offering the ophthalmology community with its first insight yet into the 4-year effects of faricimab (Vabysmo) in patients with diabetic macular edema (DME).

Results of the study, which leveraged data from patient within the YOSEMITE and RHINE trials, suggest more than 90% of people treated with faricimab achieved absence of DME at 4 years, with nearly 80% achieving dosing intervals of 3 or 4 months.¹

“I have been using Vabysmo as a first-line treatment for all the approved indications, including diabetic macular edema, and the positive long-term safety and efficacy results from the RHONE-X study are consistent with my clinical experience for over two years,” said principal investigator Arshad M. Khanani, MD, director of Clinical Research at Sierra Eye Associates and clinical professor at the University of Nevada, Reno, who presented the data at the ASRS.²

A bispecific antibody targeting VEGF and Ang-2 receptors, faricimab made history as the first bispecific antibody approved for an ophthalmic condition when it received approval from the US Food and Drug Administration in January 2022 for the treatment of neovascular age-related macular degeneration and DME. This approval, which would be followed by a subsequent indication for retinal vein occlusion in October 2023, was based on data from 4 clinical trials: TENAYA, LUCERNE, YOSEMITE, and RHINE.⁴

YOSEMITE and RHINE were identical randomized multicenter, double-masked phase 3 trials comparing use of faricimab against aflibercept among a ta combine cohort of 1891 people with DME. Both studies randomized patients in a 1:1:1 ratio to faricimab 6 mg administered every 4 months after 4 initial monthly doses, faricimab 6 mg administered every 2 months after 6 initial monthly doses, or aflibercept administered at fixed 2-month intervals after 5 initial monthly doses.³

Both trials achieved their primary endpoint, which was the mean change in BCVA from baseline at 1 year as a primary outcome of interest. In YOSEMITE, the mean change from baseline to 1 year in BCVA were +11.6 and +10.7 eye chart letters in the faricimab treat-and-extend and 2-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the mean change from baseline to 1 year in BCVA were +10.8 and +11.8 letters in the faricimab treat-and-extend and 2-month arms, respectively, and +10.3 letters in the aflibercept arm.³

RHONE-X was comprised of patients who completed either YOSEMITE or RHINE. A 2-year open-label extension trial, RHONE-X included 1474 who received faricimab 6 mg treat-and-extend with dosing intervals of up to 4 months for up to 2 years. Of the 1474 who entered RHONE-X, 81.7% completed the 2-year treatment duration.¹

Upon analysis, results indicated RHONE-X had met all primary endpoints, with use of faricimab considered well-tolerated among patients with DME. Further analysis demonstrated patients were able to maintain the visual improvement s and drying of retinal fluid during their initial phase 3 trial. Additionally, nearly 80% of patients were able to extend treatment intervals to every 3 or 4 months, more than 90% achieved absence of DME, which was defined as a central subfield thickness less than 325 microns.¹

“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, chief medical officer and head of Global Product Development at Roche.² “We are especially pleased to see that 9 out of 10 patients showed no sign of DME after four years of treatment with Vabysmo, which is an incredible long-term outcome for people living with this condition.”

References:

1. Khanani, A.M. Four-year outcomes of faricimab in DME: First-time safety and efficacy results from the RHONE-X long-term extension trial. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024
2. Roche. Roche’s Vabysmo showed extended durability, continued efficacy and a consistent safety profile in long-term diabetic macular edema (DME) study. Roche. July 17, 2024. Accessed July 19, 2024. https://www.roche.com/media/releases/med-cor-2024-07-17b.
3. Kunzmann K. FDA approves Faricimab for patients with wet AMD or DME. HCP Live. January 28, 2022. Accessed July 19, 2024. https://www.hcplive.com/view/fda-approves-faricimab-patients-wet-amd-or-dme.
4. Campbell P. Faricimab (Vabysmo) receives FDA approval for retinal vein occlusion. HCP Live. October 27, 2023. Accessed July 19, 2024. https://www.hcplive.com/view/faricimab-vabysmo-receives-fda-approval-for-retinal-vein-occlusion.