Results from the landmark RHONE-X trial reveal that patients with diabetic macular edema (DME) can maintain significant vision improvements with substantially fewer injections when treated with faricimab using a treat-and-extend dosing regimen.
The long-term, multicenter, open-label extension study followed patients from the previous YOSEMITE and RHINE trials for a total of four years, making it the first study to evaluate treat-and-extend dosing with faricimab for DME over such an extended period.
Sustained Benefits with Fewer Treatments
Dr. Matthew Starr, assistant professor of ophthalmology and Program Director of the residence program at the Mayo Clinic, presented the findings at the 2025 Retina World Congress in Fort Lauderdale, Florida.
"The highlights of that study showed that patients who received faricimab had maintained vision and central subfield thickness improvements that were seen in YOSEMITE and RHINE up to 4 years with a significantly fewer number of injections," Dr. Starr explained. "The median number of faricimab injections in year 4 for all patients was only 3."
This represents a substantial reduction in treatment burden compared to traditional fixed-interval dosing regimens, which typically require more frequent injections.
Consistent Vision Gains Across Treatment Arms
The RHONE-X trial demonstrated remarkable consistency in visual outcomes regardless of patients' original treatment assignment in the YOSEMITE and RHINE trials.
"Patients in YOSEMITE and RHINE saw about a 10-letter gain at the end of those study periods, and by the end of RHONE-X, the same letter gain was achieved," noted Dr. Starr. "All patients had about a 10-letter gain at the end of RHONE-X, irregardless of the treatment arm in YOSEMITE and RHINE, whether it was Q8 week aflibercept, Q8 week faricimab, or the treat-and-extend faricimab from the beginning."
In addition to vision improvements, patients maintained approximately 200-micron reductions in central subfield thickness (CST) from baseline throughout the study period.
Extended Treatment Intervals
One of the most significant findings from RHONE-X was the ability to extend treatment intervals substantially without compromising clinical outcomes.
"Using a treat-and-extend dosing with faricimab for patients with diabetic macular edema, many patients are able to extend it out to 12 weeks, 16 weeks, and still maintain vision and CST improvements over time," Dr. Starr emphasized.
This extended dosing capability could dramatically improve quality of life for DME patients by reducing the frequency of clinic visits and injections while maintaining therapeutic benefits.
Robust Study Design and Patient Retention
The RHONE-X trial followed nearly 1,500 eyes over the four-year period, with approximately 1,200 patients completing the study—an impressive 82% retention rate. This high completion rate strengthens the reliability of the findings and provides a rich dataset for future analyses.
While the trial has completed enrollment, Dr. Starr indicated that additional ad-hoc analyses would be performed using this comprehensive dataset to further understand the long-term effects of faricimab treatment in DME patients.
Clinical Implications
The RHONE-X findings represent a significant advancement in DME management, potentially changing treatment paradigms by demonstrating that less frequent dosing can maintain the same clinical benefits as more intensive regimens.
For clinicians, these results provide confidence in implementing treat-and-extend protocols with faricimab, potentially reducing both patient burden and healthcare resource utilization while maintaining optimal visual outcomes.
For patients with DME, who often face the prospect of indefinite treatment, the possibility of fewer injections without compromising vision improvement represents a meaningful enhancement to their care experience and quality of life.
