A randomized controlled study to compare the efficacy of intravitreal faricimab 6.0 mg versus aflibercept 2.0 mg in management of treatment-naive diabetic macular edema in Indian populations.

PURPOSE: Diabetic macular edema (DME) is a leading cause of vision loss among patients with diabetes. Anti-VEGF agents such as aflibercept have long been the cornerstone of treatment, though frequent dosing imposes a significant burden. faricimab, a bispecific antibody targeting both VEGF-A and angiopoietin-2, has emerged as a novel alternative with the potential for extended durability. Evidence from Indian populations remains limited, warranting comparative evaluation.

METHODS: This randomized controlled trial was conducted at a tertiary care institute from January 2024 to June 2025. Seventy-four treatment-naïve DME patients were randomized equally to receive either intravitreal faricimab (6.0 mg) or aflibercept (2.0 mg). All patients received three loading doses at 4-week intervals followed by as-needed retreatment based on functional and anatomical criteria. Primary outcomes included changes in best-corrected visual acuity and central macular thickness at 48 weeks. Secondary outcomes were injection frequency and safety profile.

RESULTS: Both groups were comparable at baseline. At 48 weeks, mean BCVA improvement was similar (AFL: -0.366 logMAR; FAR: -0.374 logMAR, p=NS). CMT reduction was equivalent between groups (AFL: -119 µm; FAR: -132 µm, p=NS). Faricimab achieved significantly longer mean dosing intervals (12.86 vs. 9.47 weeks, p<0.001) with fewer injections required at maintenance phase. Safety profiles were similar, with only mild, transient adverse events reported.

CONCLUSION: Faricimab demonstrated equivalent efficacy and safety to aflibercept in treatment-naïve Indian DME patients, with the added advantage of reduced injection burden and longer treatment intervals.