Efficacy, Durability and Safety of Faricimab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Oedema: Lessons Learned from Registration Trials

IntroductionThis review aims to assess the efficacy, durability and safety of faricimab-a dual vascular endothelial growth factor and angiopoietin 2 inhibitor-in patients with neovascular age-related macular degeneration (nAMD) and diabetic macula oedema (DMO). It summarises the findings of current studies on faricimab and discusses whether this new drug may fill a gap in current treatment options.MethodsWe performed a search of the PubMed, Cochrane, Web of Science and EMBASE databases for publications on faricimab between 29 November 2022 and 10 May 2023, and a search of ClinicalTrials.gov for the protocols on clinical trials for this review. We included clinical trials, case-control studies and observational studies.ResultsIn phase 3 trials of nAMD, the efficacy of faricimab was non-inferior to aflibercept (+ 5.8-6.6 vs. + 5.1-6.6 Early Treatment Diabetic Retinopathy Study [ETDRS] letters). At study end, 80% of faricimab-treated patients were on & GE; 12-week dosing intervals, and 44.9-45.7% of faricimab-treated patients were on 16-week dosing intervals. Total adverse events, as well as serious ocular adverse events, were comparable between groups. In phase 3 trials of DMO, efficacy of faricimab was non-inferior to aflibercept (+ 10.7-11.8 vs. + 10.3-10.9 ETDRS letters). At study end, > 70% of patients in the personalised treatment interval faricimab group were on & GE; 12-week dosing intervals, and 51-53% were on 16-week dosing intervals. Total adverse events were comparable between groups, although the rate of serious ocular adverse events was higher in the faricimab groups than in the aflibercept groups (1.9-3.1% vs. 0.6-1.9%, respectively). In real-world studies of treatment-resistant nAMD or DMO, faricimab demonstrated superior efficacy compared to aflibercept. In a real-world study of mostly previously treated nAMD, faricimab demonstrated some efficacy.ConclusionFaricimab demonstrated non-inferior to superior efficacy, strong durability and acceptable safety in treatment-naive nAMD and mostly treatment-naive DMO, as well as superior efficacy in treatment-resistant nAMD and DMO. However, further research is needed on faricimab in real-world settings.

Automated summary

This review assesses the efficacy, durability, and safety of faricimab in patients with nAMD and DMO. It summarizes the findings of current studies on faricimab and discusses its potential as a new treatment option.