A long-term extension study published in Ophthalmology suggests that Roche’s retinal drug faricimab (Vabysmo) may help patients with diabetic macular edema (DME) maintain vision gains for up to 4 years while reducing the frequency of eye injections.1
The findings come from the RHONE-X extension trial, which followed patients who had completed the pivotal YOSEMITE and RHINE phase 3 studies. Researchers evaluated the long-term safety, durability, and effectiveness of faricimab using a personalized treat-and-extend (T&E) dosing strategy in people with DME.
Faricimab is distinct from older retinal therapies because it targets two disease pathways simultaneously—vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2).
Overall, 1204 patients (82%) completed the RHONE-X trial. The incidence of AEs leading to treatment discontinuation (1.5%) and rates of intraocular inflammation (1.3%) were low.
According to the study, most patients entering the extension phase were able to maintain extended dosing schedules over time. Adjusted mean BCVA improvements from YOSEMITE and RHINE baseline to the end of the RHONE-X trial were +10.1 letters (faricimab T&E), +11.4 letters (faricimab T&E [prior Q8W]), and +9.5 letters (faricimab T&E [prior aflibercept]); CST reductions were –198.3 μm, –202.5 μm, and –204.9 μm, respectively. At study end, more than 90% of patients achieved DME absence, regardless of prior treatment.
Median number of injections over the RHONE-X trial (2 years) were 7 (faricimab T&E), 8 (faricimab T&E [prior Q8W]), and 8 (faricimab T&E [prior aflibercept]). By the RHONE-X trial completion, approximately 80% of patients received faricimab at ≥Q12W intervals.
Safety findings remained consistent with previous faricimab studies, and no new safety concerns emerged during long-term follow-up.
Investigators said the RHONE-X data demonstrate that individualized treatment intervals with faricimab may provide durable disease control while easing the long-term burden of care for patients and healthcare systems alike.
1. Sheth V, Schlottmann P, Lai T, et al. Four-year outcomes of faricimab in diabetic macular edema: results from the RHONE-X extension trial. Ophthalmology. 2026;Published online ahead of print. doi:10.1016/j.ophtha.2026.01.004