Clinical Evaluation of Faricimab in Real-World Diabetic Macular Edema in India- A Multicenter Observational Study
Debdulal Chakraborty, Sudipta Das, Aniruddha Maiti, Tushar Sinha, Arnab Das, Jay Sheth, Subhendu Boral, Soumen Mondal, Krishnendu Nandi
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. Keywords: diabetic macular edema, anti VEGF, faricimab