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

Year: 2026

Type: article

Abstract: 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. 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. 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). 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. Neovascular age-related macular degeneration is a common eye disease in older adults and a major cause of vision loss. The disease occurs when abnormal blood vessels grow beneath the retina and leak fluid, which damages the central part of the retina that is needed for reading and recognizing faces. This study examined how well faricimab, a medicine that targets two biological pathways involved in blood vessel growth and leakage, works during the initial treatment phase in everyday clinical practice. Doctors in a German outpatient eye clinic treated patients who had not received previous eye injections with four monthly injections of faricimab and compared eye scans and vision tests before treatment and 16 weeks later. The study showed a strong reduction in retinal swelling, indicating rapid control of disease activity. Fluid within or beneath the retina disappeared in almost all eyes that showed fluid at the start of treatment, and eyes without fluid at baseline remained fluid-free. Vision improved by about two lines on a standard eye chart, even though many patients had cataracts or corneal changes that can limit visual improvement. These findings show that, in routine clinical care, early treatment with faricimab can quickly dry the retina and lead to meaningful improvements in vision. The results support the effectiveness of faricimab during the initial treatment phase for patients with neovascular age-related macular degeneration and help to expand real-world evidence beyond clinical trials.

Source: Ophthalmology and Therapy

DOI: 10.1007/s40123-026-01385-2

Authors: Maximilian Haase, Esther Wittenborn

Institution: Roche Pharma AG (Germany)

Language: English

Topic: Retinal Diseases and Treatments

Subfield: Ophthalmology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $7,400