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Faricimab demonstrates durable efficacy in diabetic macular edema

Ophthalmology 360

Key Takeaways

  1. Faricimab showed low rates of treatment discontinuation and intraocular inflammation over two years in the RHONE-X study.
  2. Visual acuity and retinal thickness improvements achieved in earlier trials were maintained with faricimab T&E.
  3. Most patients were able to remain on extended dosing intervals, with about 80% treated every 12 weeks or longer by study end.

Faricimab given with a treat-and-extend (T&E) regimen in patients with diabetic macular edema (DM) showed low rates of treatment-limiting adverse events and maintained the visual and anatomical improvements achieved in earlier trials, with most patients able to remain on extended dosing intervals over two years, according to results from the RHONE-X extension study.

RHONE-X was a global, Phase 3, multicenter, nonrandomized, 2-year open-label extension of the YOSEMITE and RHINE trials.

Of the 1,622 patients who completed YOSEMITE/RHINE, 1,474 (91%) entered RHONE-X, and 1,204 (82%) completed the extension study. Participants transitioned to faricimab T&E without requiring monthly initiation doses and received treatment at intervals of up to 16 weeks based on best-corrected visual acuity (BCVA) and central subfield thickness (CST).

The primary endpoint focused on safety. Adverse events leading to treatment discontinuation occurred in 1.5% of patients, and intraocular inflammation was reported in 1.3%. Exploratory efficacy analyses showed that visual and anatomic outcomes achieved in YOSEMITE/RHINE were maintained through RHONE-X. Adjusted mean BCVA improvements from the original baseline to the end of RHONE-X ranged from +9.5 to +11.4 letters across prior treatment groups, while CST reductions ranged from approximately -198 to -205 μm.

At study completion, >90% of patients had absence of DME, defined as CST below 325 μm. Over the 2-year RHONE-X period, the median number of injections was 7 to 8, depending on prior treatment. By the end of the study, about 80% of patients were receiving faricimab at dosing intervals of 12 weeks or longer.

Reference

Sheth VS, Schlottmann P, Lai TYY, et al. Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results From the RHONE-X Extension Trial. Ophthalmology. 2026;S0161-6420(26)00004-7. doi: 10.1016/j.ophtha.2026.01.001. Epub ahead of print. PMID: 41534798.

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