Summary of Research: Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results From the RHONE-X Extension Trial

This is a summary of the original article "Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results From the RHONE-X Extension Trial." RHONE-X was a phase 3, multicenter, nonrandomized, 2-year open-label extension of the YOSEMITE/RHINE clinical trials. RHONE-X assessed the long-term safety (primary endpoint) and efficacy (exploratory) of faricimab using a treat-and-extend (T&E) protocol in patients with diabetic macular edema (DME). Patients in YOSEMITE/RHINE who received faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg T&E, or aflibercept 2.0 mg Q8W received faricimab 6.0 mg up to Q16W T&E (based on prespecified vision and anatomic criteria) for a further 2 years in RHONE-X. Faricimab was well tolerated through 2 years of RHONE-X, and adverse events reported were consistent with the known safety profile of faricimab. Vision and anatomical improvements achieved during YOSEMITE/RHINE were maintained through RHONE-X. In patients treated with aflibercept during YOSEMITE/RHINE, the proportion achieving absence of DME (CST < 325 µm) increased after switching to faricimab. Approximately 80% of patients were on a faricimab dosing interval of ≥ Q12W at the end of 4 years. These findings demonstrated the long-term safety, efficacy, and durability of faricimab T&E in patients with DME.