Faricimab Approval Status for Diabetic Macular Edema Outside the United States
Yes, faricimab is approved for diabetic macular edema (DME) outside the United States, specifically in Japan, and was under regulatory review in the European Union as of 2022. 1
International Approval Timeline and Status
Japan received approval for faricimab for the treatment of DME shortly after the initial U.S. approval in January 2022, making it one of the first countries outside the United States to approve this medication. 1
The European Union had faricimab under regulatory review for both neovascular age-related macular degeneration and DME as of early 2022. 1
Phase III clinical development continues in multiple other countries worldwide for DME and other retinal vascular conditions, indicating ongoing expansion of international availability. 1
Clinical Evidence Supporting International Use
Japanese patients demonstrated comparable efficacy to the global population in the YOSEMITE trial, with mean best-corrected visual acuity improvements of +11.1 letters with faricimab every 8 weeks and +8.1 letters with personalized treatment intervals at 1 year. 2
Extended dosing intervals were achievable in Japanese patients, with 72% achieving dosing intervals of 12 weeks or longer, and 39% achieving every-16-week dosing by week 52, demonstrating durability consistent with global results. 2
Anatomic improvements and safety profiles in Japanese patients were consistent with the pooled global cohort, with no new or unexpected safety signals identified in this population. 2
Current Guideline Recognition
The American Diabetes Association's 2025 guidelines acknowledge faricimab as one of five anti-VEGF agents currently used for center-involved DME, alongside bevacizumab, ranibizumab, aflibercept (2 mg and 8 mg), and brolucizumab. 3, 4
Faricimab represents a novel dual-pathway inhibition mechanism, targeting both VEGF-A and angiopoietin-2, which distinguishes it from traditional anti-VEGF monotherapies. 1