Real-world outcomes of faricimab in treatment-naïve diabetic macular edema: The Middle East perspective.

PURPOSE: Diabetic macular edema (DME) is a major cause of visual impairment in patients with diabetic retinopathy. While intravitreal anti-vascular endothelial growth factor (anti-VEGF) monotherapy has been considered standard of care, many patients have suboptimal treatment responses. Faricimab, which targets angiopoietin-2 and VEGF-A, has shown efficacy and tolerability in randomized controlled trials (RCTs). As RCT results are often challenging to replicate in real-world practice, this study assessed the impact of faricimab on DME outcomes in Middle Eastern real-world settings. METHODS: Treatment-naïve patients with DME receiving faricimab between 2023 and 2025 with ≥6 months follow-up were examined at five sites in Egypt, Saudi Arabia, and Qatar. Following loading doses, patients were treated with either pro re nata or treat-and-extend regimens. Outcomes included visual acuity (VA), retinal thickness, number of injections, and adverse events (AEs). Data were analyzed separately by site. RESULTS: Eighty-eight eyes were treated across sites, with mean follow-up ranging from 7.6 to 12.5 months. Mean number of faricimab injections ranged from 3.0 to 4.2. Improvements from baseline in VA (mean logarithm of the Minimal Angle of Resolution reductions between -0.16 and -0.49) and retinal thickness (mean reductions between -50.6 μm and -194.0 μm) were observed with faricimab treatment at all sites, regardless of differences in treatment protocol or observation time points. No AEs of intra-ocular inflammation or endophthalmitis were observed. CONCLUSION: The findings suggest faricimab conferred visual and anatomical improvements in a heterogeneous group of patients with DME in real-world Middle East settings. Further real-world studies are essential to confirm long-term safety and effectiveness in clinical practice.