The Real-World Efficacy and Safety of Faricimab in Diabetic Macular Edema: The TAHOE Study

Authors

Huma Khan
Hannah Khan
Aamir A. Aziz
Greggory Gahn
Mark Rami Barakat
Giulia Corradetti
Carl J. Danzig
Jordan M. Graff
Jared Nielsen
Jeremy Wolfe, Corewell Health
SriniVas R. Sadda
Arshad M. Khanani

Document Type

Conference Proceeding

Publication Date

6-2024

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

Purpose : Faricimab was FDA-approved for diabetic macular edema (DME) in January 2022. This multi-center, prospective study evaluates the safety and efficacy of faricimab in real-world patients diagnosed with DME.

Methods : This study investigates both treatment-naive patients and patients that switched to faricimab from other anti-VEGF agents. Data collected included demographics, treatment history, best-corrected visual acuity (BCVA), central subfield thickness (CST), and presence of subretinal or intraretinal fluid (SRF or IRF). Snellen visual acuity was converted to Early Treatment Diabetic Retinopathy Study (ETDRS) scoring. Improvements in visual acuity and CST are evaluated as averages. Improvements in retinal fluid are evaluated as a proportion. Observed and calculated data is reported. Safety is summarized.

Results : A total of 181 eyes across 136 patients were recorded. The average age was 69.2 years; 50.7% were male and 21.5% had switched from aflibercept. A total of 756 injections have been recorded. All eyes post one injection of faricimab (n=140) had a BCVA increase of +2.16 letters (p=0.353) and a CST decrease of -36.16 um (p=0.066). All eyes post three injections of faricimab (n=94) had a BCVA increase of +3.78 letters (p=0.146), a CST decrease of -45.28um (p=0.052). No cases of intraocular inflammation, endopthalmitis, vasculitis or retinal artery occlusion have been observed.

Conclusions : Faricimab has demonstrated efficacy via anatomic and visual parameters in both treatment-naive and previously treated patients, a demographic not studied in the trials leading to FDA-approval. No safety cases related to inflammation have been observed. Future results will continue to investigate the long term safety, efficacy and durability of faricimab in real-world patients with DME. Latest data will be presented at ARVO 2024.

Volume

65

Issue

7

First Page

6259

Comments

Association for Research in Vision and Ophthalmology Annual Meeting, ARVO 2024, May 5-9, 2024, Seattle, WA

Recommended Citation

Khan H, Khan H, Aziz AA, Gahn G, Barakat MR, Corradetti G, et al. [Wolfe J]. The real-world efficacy and safety of faricimab in diabetic macular edema: the TAHOE study. Invest Ophthalmol Vis Sci. 2024 Jun;65(7):6259.