The YOSEMITE/RHINE Phase 3 trials evaluating the intravitreal faricimab for the treatment of diabetic macular edema (DME) have yielded promising results. Over the 2-year study period, faricimab demonstrated clinically meaningful visual acuity gains, anatomic improvements, and extended durability when administered through a personalized treat-and-extend (T&E)-based dosing regimen. The dual angiopoietin-2/vascular endothelial growth factor (VEGF)-A pathway inhibition with faricimab, especially with up to every 16-week dosing, was shown to be comparable in efficacy and safety to the current treatment, aflibercept.
The randomized, double-masked, noninferiority trials involved adults experiencing visual acuity loss due to center-involving DME. Participants were assigned to 1 of 3 groups: faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg with a treat-and-extend (T&E) regimen, or aflibercept 2.0 mg every 8 weeks (Q8W). The T&E regimen allowed for dosing up to every 16 weeks (Q16W) based on central subfield thickness (CST) and best-corrected visual acuity (BCVA) change.
The results, encompassing 940 participants in YOSEMITE and 951 in RHINE, demonstrated that noninferior visual acuity gains observed in the first year were maintained through the second year. The mean BCVA change from baseline at 2 years with faricimab Q8W or T&E was comparable to aflibercept Q8W. Importantly, the median number of injections was significantly lower in the faricimab T&E group compared to faricimab Q8W and aflibercept Q8W.
Durability of the faricimab T&E regimen was notably enhanced during the second year, with more than 60% of patients on Q16W dosing and approximately 80% on at least Q12W dosing at week 96. A substantial proportion of patients who achieved Q16W dosing at week 52 maintained this dosing frequency without reduction through week 96.
Additional positive outcomes included greater mean CST reductions, higher rates of absence of DME, and absence of intraretinal fluid with faricimab Q8W or T&E compared to aflibercept Q8W over the 2-year period.
Overall, faricimab exhibited a safety profile comparable to aflibercept.
Reference
Wong TY, Haskova Z, Asik K, et al; YOSEMITE and RHINE Investigators. Faricimab Treat-and-Extend for Diabetic Macular Edema: 2-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology. 2023;S0161-6420(23)00933-8. doi: 10.1016/j.ophtha.2023.12.026. Epub ahead of print. PMID: 38158159.
Related Content
