Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials

Abstract

Purpose: To assess the 1-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema from Asian and non-Asian countries. Design: Global, multicenter, randomized, double-masked, active comparator-controlled, phase III trials. Methods: Subgroup analysis of patients from Asian (N=144) and non-Asian (N=1747) countries randomized to faricimab 6.0 mg every 8 weeks (Q8W), faricimab per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W in the YOSEMITE/RHINE (NCT03622580/NCT03622593) trials. Primary endpoint: best-corrected visual acuity (BCVA) changes from baseline at 1 year, averaged over weeks 48, 52, and 56. Results: Mean BCVA change from baseline at 1 year in the Asian country subgroup was similar between arms: faricimab Q8W (n=50), +10.9 (95% CI: 8.6–13.2); faricimab PTI (n=48) +10.0 (7.7–12.4) letters; aflibercept Q8W (n=46) +9.0 (6.6–11.4) letters. BCVA gains in the non-Asian country subgroup (n=582, 584, 581) were +11.3 (10.5–12.1), +11.2 (10.5–12.0), and +10.7 (9.9–11.5) letters, respectively. At 1 year, 49% of Asian country patients in the faricimab PTI arm achieved Q16W dosing (vs. 52% non-Asian) and 78% achieved ≥Q12W dosing (vs. 72% non-Asian). Anatomic improvementswere generally greater with faricimab versus aflibercept and similar between the Asian and non-Asian country subgroups. Faricimab was well tolerated, with no new safety signals. Conclusions: Vision, durability, anatomic, and safety outcomes were generally similar between the Asian and non-Asian country subgroups, suggesting that global YOSEMITE/RHINE results may be generalized to the Asian population. These data support the benefit-risk profile of faricimab for treating Asian patients with diabetic macular edema.

Effects of switching from intravitreal injection of aflibercept to faricimab on ocular blood flow in patients with diabetic macular edema

“…These results are consistent with those of the YOSEMITE and RHINE studies, which reported that the efficacy of faricimab was not inferior to that of aflibercept 2 . In addition, a subgroup analysis of patients in the YOSEMITE and RHINE trials revealed similar results in Asian and non-Asian countries 8 and when limited to the patients in Japan 9 . Kusuhara et al reported that the overall mean CMT after switching from IVA to IVF decreased significantly from the baseline value 1 month after administration 10 .…”

Beyond VEGF: Angiopoietin–Tie Signaling Pathway in Diabetic Retinopathy

“…A systematic literature review identified 26 randomized clinical trials published before August 2021 that were used to conduct a network meta-analysis to compare faricimab treatment and extend to intravitreal aflibercept, ranibizumab, bevacizumab, dexamethasone implant and laser treatment [181]. Network meta-analysis allow treatments that are not compared directly within randomized clinical trials to be compared indirectly.…”

“…In this network meta-analysis at 12 months of follow-up, treatment and extended treatment regimen for faricimab demonstrated superior retinal drying which was achieved with fewer injections when compared to other flexible dosing regimens. In addition, visual outcomes at 12 months were superior with the treat and extend faricimab when compared to bevacizumab and ranibizumab [181]. Another systematic review and meta-analysis of three randomized clinical trials from 2013 to 2023 that included 2120 patients with DME concluded that faricimab was a better drying agent as manifested by a greater reduction in CST compared to other anti-VEGF agents [182].…”