Rapid Effects on Anatomical and Functional Outcomes following Upload with Faricimab in Treatment-Naïve nAMD: German Single-Center Study 45DRY

INTRODUCTION: The bispecific antibody faricimab inhibits vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2), two key mediators in the pathophysiology of neovascular age-related macular degeneration (nAMD), which is characterized by choroidal neovascularization, vascular instability, leakage, and intra/subretinal fluid with consequent vision loss. The aim of our study was to assess the effectiveness of faricimab at week 16 versus baseline in patients with treatment-naïve nAMD managed under real-world conditions in Germany. METHODS: 45DRY was a retrospective, single-center analysis of consecutive patients with treatment-naïve nAMD initiating faricimab (four monthly injections at weeks 0, 4, 8, and 12). Outcomes were evaluated at baseline and week 16 (± 14 days). The primary endpoint was change from baseline in central retinal thickness (CRT); secondary endpoints were change in best-corrected visual acuity (BCVA) and presence/absence of intraretinal fluid (IRF), subretinal fluid (SRF), combined IRF + SRF, and subretinal pigment epithelium (sub-RPE) fluid. Analyses were descriptive. RESULTS: A total of 45 eyes from 45 patients were included (mean age 82.1 years; 51.1% female). Mean CRT decreased by -140.8 μm from 343.1 µm at baseline to 202.4 µm at week 16 [95% confidence interval (CI) -178.2 to -103.3]. Mean BCVA improved by -0.15 logMAR at week 16. Among eyes with retinal fluid at baseline, IRF resolved in 100% (24/24), SRF in 94.1% (32/34), combined IRF + SRF in 100% (17/17), and sub-RPE fluid in 90% (9/10). Maintenance of fluid-free status was universal in eyes negative at baseline for IRF (21/21), SRF (11/11), and combined IRF + SRF (28/28); sub-RPE fluid remained absent in 100% (35/35). CONCLUSIONS: In routine clinical practice, a four-dose faricimab upload per label at the time of study conduct led to a rapid and substantial anatomical drying effect at week 16 with improvement in BCVA and marked CRT reduction. These real-world findings confirm that faricimab rapidly and effectively reduces retinal fluid, in line with post hoc analyses of the pivotal TENAYA and LUCERNE trials.

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Journal
Ophthalmology and Therapy
Published
2026-04-25
DOI
https://doi.org/10.1007/s40123-026-01385-2
Primary Topic
Protease and Inhibitor Mechanisms
Type
article
Field-Weighted Citation Impact
0.00

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article

Rapid Effects on Anatomical and Functional Outcomes following Upload with Faricimab in Treatment-Naïve nAMD: German Single-Center Study 45DRY

Esther Wittenborn, Maximilian Haase
Ophthalmology and Therapy
Protease and Inhibitor Mechanisms
article

Rapid Effects on Anatomical and Functional Outcomes following Upload with Faricimab in Treatment-Naïve nAMD: German Single-Center Study 45DRY

Esther Wittenborn, Maximilian Haase
article en

Abstract

INTRODUCTION: The bispecific antibody faricimab inhibits vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2), two key mediators in the pathophysiology of neovascular age-related macular degeneration (nAMD), which is characterized by choroidal neovascularization, vascular instability, leakage, and intra/subretinal fluid with consequent vision loss. The aim of our study was to assess the effectiveness of faricimab at week 16 versus baseline in patients with treatment-naïve nAMD managed under real-world conditions in Germany. METHODS: 45DRY was a retrospective, single-center analysis of consecutive patients with treatment-naïve nAMD initiating faricimab (four monthly injections at weeks 0, 4, 8, and 12). Outcomes were evaluated at baseline and week 16 (± 14 days). The primary endpoint was change from baseline in central retinal thickness (CRT); secondary endpoints were change in best-corrected visual acuity (BCVA) and presence/absence of intraretinal fluid (IRF), subretinal fluid (SRF), combined IRF + SRF, and subretinal pigment epithelium (sub-RPE) fluid. Analyses were descriptive. RESULTS: A total of 45 eyes from 45 patients were included (mean age 82.1 years; 51.1% female). Mean CRT decreased by -140.8 μm from 343.1 µm at baseline to 202.4 µm at week 16 [95% confidence interval (CI) -178.2 to -103.3]. Mean BCVA improved by -0.15 logMAR at week 16. Among eyes with retinal fluid at baseline, IRF resolved in 100% (24/24), SRF in 94.1% (32/34), combined IRF + SRF in 100% (17/17), and sub-RPE fluid in 90% (9/10). Maintenance of fluid-free status was universal in eyes negative at baseline for IRF (21/21), SRF (11/11), and combined IRF + SRF (28/28); sub-RPE fluid remained absent in 100% (35/35). CONCLUSIONS: In routine clinical practice, a four-dose faricimab upload per label at the time of study conduct led to a rapid and substantial anatomical drying effect at week 16 with improvement in BCVA and marked CRT reduction. These real-world findings confirm that faricimab rapidly and effectively reduces retinal fluid, in line with post hoc analyses of the pivotal TENAYA and LUCERNE trials.

Ophthalmology and Therapy
Roche (Switzerland) (CH), Krankenhaus Nordwest (DE)
Roche Deutschland
Openalex Percentile: Top 6%
Protease and Inhibitor Mechanisms
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