Clinical Evaluation of Faricimab in Real-World Diabetic Macular Edema in India- A Multicenter Observational Study.

Abstract

Purpose: To evaluate the efficacy of faricimab in real-world clinical settings in India for treating diabetic macular edema (DME) in treatment-naïve and recalcitrant eyes.

Patients and methods: This retrospective study involved 39 eyes (16 treatment-naive and 23 recalcitrant) treated with intravitreal faricimab at four centers in India. Patients received three monthly loading doses followed by a pro-re-nata regimen, with outcomes measured for best-corrected visual acuity (BCVA), central macular thickness (CMT), intraretinal fluid (IRF), subretinal fluid (SRF), and hyperreflective foci (HRF).

Results: Significant improvements in BCVA were observed in both treatment-naïve and recalcitrant groups, with greater gains in the naïve group (p<0.001). Overall, BCVA improved from 0.48 logMAR to 0.27 logMAR (P<0.001), and 59% of eyes gained more than 10 ETDRS letters and 41% gaining >15 ETDRS letters. Both groups showed significant reduction in CMT, with the naïve group achieving greater reduction (P<0.001). The overall CMT reduction was statistically significant at 6 months (P<0.001). Resolution of IRF and SRF was achieved in both groups, with SRF reducing from 82.1% to 20.5% (P<0.001) and IRF from 87.2% to 17.9% (P<0.001). Significant reductions in HRF were also observed across both inner (P<0.001) and outer retinal layers (P<0.001). No ocular or systemic adverse events were reported.

Conclusion: Faricimab treatment resulted in significant improvements in visual acuity and anatomical outcomes in both treatment-naïve and recalcitrant DME eyes, highlighting its potential as a valuable therapeutic option in diverse clinical settings. Further real-world studies are warranted to establish long-term efficacy and safety.