Real-World Evidence for Faricimab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Scoping Review.

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.