Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial

Abstract

Purpose To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME). Study design Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593). Methods Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was bestcorrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared. ResultsThe YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04% confidence interval) BCVA change at 1 year in the Japan subgroup was comparable with faricimab Q8W (+11. 1 [7.6-14.6] letters), faricimab ] letters), and aflibercept Q8W (+6.9 [3.3-10.5] letters). At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing. Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. Faricimab was well tolerated; no new or unexpected safety signals were identified. Conclusion Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.

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 .…”

Characterization of the visually impaired patients with diabetes mellitus in Japan

“…For recurrent edema, the prognosis for vision is poor if injections are not administered promptly; thus, administering a sufficient number of injections is recommended 21 . Although frequent injections increase the economic burden on patients 22 , new anti‐VEGF agents such as brolucizumab and faricimab have been developed for diabetic macular edema, and regimens with longer dosing intervals have been proposed 23 , 24 , 25 . Advances in drug therapy are expected to reduce the visual impairment caused by diabetic macular edema in the future.…”