Beyond Central Subfield Thickness: Early Multi-Slice Optical Coherence Tomography Structural Response After Faricimab Injection in Real-World Diabetic Macular Edema.

Objectives

We sought to evaluate the early efficacy of faricimab (Vabysmo®) in treating diabetic macular edema (DME) and to explore the predictive value of multi-slice optical coherence tomography (OCT) biomarkers for anatomical and visual outcomes.

Methods

In this retrospective cohort study, 26 anti-VEGF-naive DME patients (36 eyes) treated with intravitreal faricimab were analyzed from baseline through 6 months of follow-up. Best-corrected visual acuity (BCVA) was recorded, while central subfield thickness (CST) and various OCT biomarkers were evaluated using multi-slice OCT quantitative analysis. Logistic and linear regression models were utilized to examine predictive factors, and scatter plots were employed to assess the correlation between anatomical improvement and functional visual gain.

Results

Changes in CST and BCVA, along with the evolution and predictive power of OCT biomarkers-including vitreomacular interface (VMI), epiretinal membrane (ERM), disorganization of the retinal inner layers (DRIL), intraretinal cysts (IRCs), hyperreflective foci (HRF), hard exudates (HEs), large outer-nuclear-layer cavities (LONLCs), ellipsoid zone disruption (EZD), and subretinal fluid (SRF)-were assessed. Post-treatment CST demonstrated rapid and significant reduction, decreasing from 377.7 μm (95% CI: 347.0-408.4) at baseline to 312.8 μm (95% CI: 287.5-338.2; p < 0.0001) at month 3 and 291.5 μm (95% CI: 275.6-307.4; p < 0.0001) at month 6, with an approximately 48 μm reduction post-first injection. Overall intraocular pressure (IOP) and BCVA showed no statistically significant improvement. Baseline analysis indicated that EZD was significantly associated with older age (p = 0.029), worse initial BCVA (p = 0.005), and thicker CST (p = 0.002). After adjusting for initial CST in the linear regression model, we identified the presence of baseline HEs as the sole independent predictor of substantial anatomical improvement (B = 45.9, p = 0.002).

Conclusions

Faricimab demonstrated rapid and significant early anatomical improvements. Baseline HEs independently predicted the extent of CST reduction, potentially reflecting the greater fluid burden of eyes with more severe barrier breakdown. Baseline EZD was observed exclusively among eyes that did not achieve complete anatomical remission, although the small number of EZD-positive eyes (n = 7) precludes firm conclusions.