Efficacy of Intravitreal Faricimab for Diabetic Macular Edema and Analysis of Influencing Factors.

Abstract

Objective:  To evaluate the efficacy and safety of intravitreal faricimab administered under a treat-and-extend (T&E) strategy for DME in a real-world clinical setting, and to analyze factors associated with visual acuity benefits and durability of disease control during interval extension.

Methods:  This single-center, retrospective cohort study included 170 patients (170 eyes) with diabetic macular edema who initiated intravitreal faricimab treatment between January 2024 and December 2024 and completed at least 12 months of follow-up. Only one eye per patient was included in the analysis. All included eyes completed a three-dose monthly loading phase and were subsequently managed using a faricimab-based treat-and-extend regimen. The primary efficacy endpoints were changes in best-corrected visual acuity (BCVA, ETDRS letters) and central subfield thickness (CST) at 12 months. Key secondary T&E-related endpoints included the total number of injections within 12 months, the maximum treatment interval achieved by month 12, and the proportion of eyes reaching extension intervals of ≥12 and ≥16 weeks. Multivariable linear regression and Cox proportional hazards regression were used to identify exploratory factors associated with visual acuity improvement and time to treatment interval shortening.

Results:  At 12 months, mean BCVA improved by 9.7 ± 11.5 letters and mean CST decreased by 191.0 ± 135.0 µm (both P < 0.001); 50.0% gained ≥10 letters and 64.7% achieved a dry macula (CST < 300 µm). In multivariable regression, 1-month CST reduction showed the strongest positive association with BCVA gain (B = 0.48 per 100 µm decrease, β = 0.41, P < 0.001), while baseline HbA1c, baseline CST, and ellipsoid zone impairment were negatively associated. Higher baseline HbA1c, CST ≥500 µm, and EZ impairment were associated with interval shortening during the maintenance phase. No serious adverse events occurred.

Conclusion:  In real-world DME treated with a T&E faricimab regimen, patients achieve sustained functional and anatomical improvements with a favorable safety profile. Twelve-month outcomes and treatment durability were associated with baseline metabolic control, anatomical disease severity, and early CST response, supporting individualized monitoring during treat-and-extend management.