Two-Year Real-World Outcomes of Faricimab for Diabetic Macular Edema in Japan.

Abstract

Background: Diabetic macular edema (DME) is a leading cause of vision loss in working-age adults. Faricimab, a bispecific antibody targeting VEGF and Ang-2, has been shown to reduce treatment burden by enabling extended injection intervals. However, real-world, long-term data from Japanese populations are limited.

Purpose: To evaluate the two-year efficacy and safety of intravitreal faricimab for DME in a real-world clinical setting in Japan.

Methods: This retrospective observational study was conducted at the International Goodwill Hospital, Yokohama, Japan. Patients with DME who were followed for two years after initiating intravitreal faricimab. Outcome measures included central subfield thickness (CST), best-corrected visual acuity (BCVA), macular fluid resolution, and recurrence. Changes were evaluated using nonparametric tests and survival analysis.

Results: We analyzed 9 patients (16 eyes) with DME who were followed for two years after initiating intravitreal faricimab. A four-injection loading phase was omitted in all but one case, with a median of one initial injection. CST decreased from 332.3 µm to 267.0 µm (p = 0.069), and BCVA remained stable (0.49 to 0.55 logMAR, p = 0.2081). Complete macular fluid resolution occurred in 87.5% of eyes, with a median resolution time of 6 months. Recurrence occurred in 37.5% of eyes during follow-up, with a median time to recurrence of 9 months. Among eyes on fixed dosing (n = 11), 72.7% achieved a final injection interval of ≥12 weeks. Intraretinal fluid (IRF) significantly decreased (p = 0.0078), and chronic cystoid changes were associated with limited CST reduction (p = 0.016). No treatment-related adverse events were reported.

Conclusion: Faricimab demonstrated favorable anatomical outcomes and extended injection intervals over two years in a real-world setting, despite the omission of a loading phase in most cases. These findings support its practical utility of faricimab for DME management in Japan.