Abstract
PURPOSE: Since faricimab (Vabysmo) was approved for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), a growing body of real-world data has been reported, forming an important source of evidence for faricimab in a heterogeneous population. Scoping reviews are an effective approach to comprehensively assess the state of evidence on areas yet to be well characterized, allowing for the inclusion of a wide range of study designs and methodologies. This scoping review aimed to assess the current breadth and nature of real-world evidence (RWE) for faricimab and describe its safety and effectiveness in routine clinical practice. DESIGN: Scoping review of published articles and grey literature. PARTICIPANTS: Eligible records included primary research reporting on any real-world data from ≥5 participants treated with faricimab in its licensed indications, published in English since 2022. This review did not involve novel data collection in human participants. METHODS: MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched on February 16, 2024, and the results were reviewed by 2 independent reviewers. Manual searches of proceedings from major relevant conferences, ClinicalTrials.gov, and bibliographies of relevant systematic literature reviews were also conducted. Findings were summarized descriptively. MAIN OUTCOME MEASURES: Data of interest included study design, population characteristics, treatment history, visual function and anatomic outcomes, patient-reported outcomes, safety, and economic outcomes. RESULTS: A total of 63 studies reporting RWE for faricimab in patients with nAMD or DME (n = 6-12 119 eyes) were identified, including a majority of studies in previously treated patients. Studies spanned 10 countries, with a predominance of retrospective observational studies. Results across the majority of studies suggested that faricimab was associated with improved visual acuity, reduced central choroidal/subfield macular thickness, and reduced/resolved retinal fluid and pigment epithelial detachment in both conditions, even over longer study periods (≥6 months). Adverse events reported were similar to the findings within the registration trials. CONCLUSIONS: Outcomes of faricimab in routine practice align with reports from clinical trials, supporting the effectiveness and safety of faricimab in heterogeneous populations. Further high-quality studies using prospective, multicenter designs are required to provide a more comprehensive understanding of the long-term outcomes associated with faricimab. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.