OBJECTIVES: One of the main causes of vision loss for patients with diabetes is diabetic macular edema (DME). Intravitreal injections of anti-vascular drugs is currently the first-line treatment for DME involving the macula center. Faricimab is a new angiogenesis inhibitor, targeting both Ang/Tie and vascular endothelial growth factor-A (VEGF-A) pathways. The aim of the study was to conduct a comparative analysis of efficacy and safety of faricimab and other treatments for DME.

METHODS: Systematic review (SR) of randomized clinical trials (RCTs) published before December 2022 was carried out via PRISMA guideline to evaluate the comparative efficacy and safety of faricimab 6 mg vs aflibercept 2 mg, ranibizumab 0.3/0.5 mg. To conduct an indirect comparison RCTs with data on six 1-year endpoints were selected. Forest plots with 95% CI were obtained for faricimab 6 mg in at 8-week or adjustable (up to 16 weeks) intervals compared with aflibercept 2 mg and ranibizumab 0.3/0.5 mg in various fixed, pro re nata and treat-and-extend regimens.

RESULTS: From 2845 initial publications 272 were eligible and 38 studies were included in the SR. The core network was formed from 20 RCTs. Fixed effect models were consistent in network meta-analysis (NMAs) of five endpoints: best-corrected visual acuity (BCVA) and central retinal thickness (CRT) changes from the baseline, gaining 15 or more ETDRS letter in visual acuity, incidence of ocular adverse events and treatment discontinuation. Random effect model was selected for NMA of injections frequency. Faricimab 6 mg up to 16 weeks is associated with superior or comparable visual (BCVA) and anatomical (CRT) 1-year outcomes and lower injection frequency than aflibercept or ranibizumab in various regimens. No significant difference was found for gaining 15 or more letters, treatment discontinuation and adverse events between comparators.

CONCLUSIONS: 1-year efficacy and safety of faricimab in patients with DME are comparable to other angiogenesis inhibitors.