The Real-World Efficacy and Safety of Faricimab in Diabetic Macular Edema: First Time Two-Year Results of the TAHOE Study

Document Type

Conference Proceeding

Publication Date

6-2025

Publication Title

Investigative Ophthalmology and Visual Science

Abstract

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

Methods : This study investigates both treatment-naïve patients and patients 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 669 eyes across 411 patients were recorded. The average age was 65.5 years, 50.6% were male and 21.4% had switched from aflibercept. A total of 3,104 injections have been recorded. All eyes switched from any agent post three injections of faricimab (n=249) had a BCVA increase of +2.14 letters (p=0.0102) and a CST improvement of -31.27μm (p< 0.0001). Eyes switched from aflibercept post three injections of faricimab (n=128) had a BCVA increase of +0.63 letters (p=0.1987) and a CST improvement of -24.11μm (p=0.0009). All eyes switched from any agent post nine injections of faricimab (n=51) had a BCVA increase of +3.39 letters (p=0.0267) and a CST improvement of -56.48μm (p=0.0008). Eyes switched from aflibercept post nine injections of faricimab (n=30) had a BCVA increase of +3.88 letters (p=0.1107) and a CST improvement of -49.20μm (p=0.0012). Intraocular inflammation was noted at a rate of 0.09% per injection.

Conclusions : Faricimab has demonstrated efficacy via anatomic and visual parameters, in both treatment-naïve and previously treated real-world patients. Safety is comparable to current agents. 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 2025.

Volume

66

Issue

8

First Page

3789

Comments

Association for Research in Vision and Ophthalmology ARVO Annual Meeting, May 4-8, 2025, Salt Lake City, UT

Last Page

3789

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