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

Helene O Larsen; Jakob Grauslund; Anna S Vergmann

doi:10.1007/s40123-023-00753-6

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

Ophthalmol Ther. 2023 Oct;12(5):2253-2264. doi: 10.1007/s40123-023-00753-6. Epub 2023 Jul 6.

Authors

Helene O Larsen¹, Jakob Grauslund^{2

3

4

5}, Anna S Vergmann^{2

3}

Affiliations

¹ Research Unit of Ophthalmology, Department of Ophthalmology, Odense University Hospital, J. B. Winsløws Vej 4, 5000, Odense C, Denmark. helene@odla.dk.
² Research Unit of Ophthalmology, Department of Ophthalmology, Odense University Hospital, J. B. Winsløws Vej 4, 5000, Odense C, Denmark.
³ Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
⁴ Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark.
⁵ Department of Ophthalmology, Vestfold Hospital Trust, Tønsberg, Norway.

Abstract

Introduction: This 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.

Methods: We 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.

Results: In 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 ≥ 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 ≥ 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.

Conclusion: Faricimab demonstrated non-inferior to superior efficacy, strong durability and acceptable safety in treatment-naïve nAMD and mostly treatment-naïve DMO, as well as superior efficacy in treatment-resistant nAMD and DMO. However, further research is needed on faricimab in real-world settings.

Keywords: Diabetic macular oedema; Faricimab; Neovascular age-related macular degeneration.

Publication types

Review