Key Takeaways

  • Four-year RHONE-X data showed faricimab maintained double-digit vision gains and substantial retinal drying in patients with DME
  • Treatment burden continued to decline over time, with approximately 80% of patients maintained on dosing intervals of 12 weeks or longer after 4 years 
  • Faricimab demonstrated a favorable long-term safety profile

Faricimab (Vabysmo; Genentech) continued to deliver durable visual and anatomical benefits for patients with diabetic macular edema (DME) through 4 years of follow-up, according to results from the phase 3 RHONE-X extension study published in Ophthalmology.1

The RHONE-X study enrolled 1,474 patients who completed the pivotal YOSEMITE and RHINE trials, making it one of the largest long-term extension studies conducted in DME. More than 1,200 patients completed the 2-year extension, representing an overall 4-year treatment experience for many participants.

Investigators reported that visual acuity gains achieved during the original YOSEMITE and RHINE studies were largely maintained throughout the extension period. At year 4, patients originally treated with faricimab gained between 10 and 11 ETDRS letters from baseline, while those who switched from aflibercept to faricimab maintained gains of approximately 9.5 letters.

Retinal anatomy improvements also remained robust. Central subfield thickness reductions exceeded 198 microns across all treatment groups at year 4, demonstrating sustained fluid control. More than 90% of patients achieved protocol-defined absence of DME by the end of the study, regardless of whether they had originally received faricimab or aflibercept.

During the 2-year RHONE-X extension, patients required a median of seven to eight injections. By the fourth year of treatment, approximately 80% of patients were being maintained on dosing intervals of at least 12 weeks, while more than 60% were receiving injections every 16 weeks.

Long-term safety findings were broadly consistent with previous faricimab studies. The incidence of intraocular inflammation was 1.3%, with no reported cases of retinal vasculitis or retinal occlusive vasculitis. Adverse events leading to treatment discontinuation occurred in just 1.5% of patients. Investigators reported low rates of treatment-related serious ocular adverse events, and most inflammation-related events were mild or moderate and resolved during the study period.

The authors concluded that faricimab's long-term efficacy, extended dosing intervals and favorable safety profile support its role in the chronic management of DME.

Reference

1. 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;133(5):599-612. doi:10.1016/j.ophtha.2026.01.001.