Ophthalmology and therapy · 2026
Rapid Effects on Anatomical and Functional Outcomes following Upload with Faricimab in Treatment-Naïve nAMD: German Single-Center Study 45DRY.
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Haase Maximilian, Wittenborn Esther
Аннотация
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.
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.