Of note, the angiopoietin (Ang)-1/Tie2 signaling pathway is a key regulator of vascular stability under physiological conditions which, in DME and other retinal vascular diseases, is disrupted by Ang-2 upregulation. Intravitreal anti–vascular endothelial growth factor (VEGF) therapy is the standard first-line treatment for Japanese patients with center-involving DME however, DME is a multifactorial disease with mechanisms beyond VEGF upregulation that contribute to fluid accumulation in the macula. ConclusionĬonsistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.ĭiabetic retinopathy, including diabetic macular edema (DME), is a vision-threatening complication of diabetes and a leading cause of visual impairment among working-aged people in Japan. Faricimab was well tolerated no new or unexpected safety signals were identified.
Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing.
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 letters), faricimab PTI (+8.1 letters), and aflibercept Q8W (+6.9 letters). The YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). 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. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. 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. Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 trials (YOSEMITE, NCT03622580 RHINE, NCT03622593).
To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME).
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