{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T14:26:25Z","timestamp":1783347985363,"version":"3.54.6"},"reference-count":21,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>Background and Objectives: Faricimab, the first bispecific antibody targeting VEGF-A and angiopoietin-2, has demonstrated durable efficacy in pivotal phase 3 trials for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Real-world data on treatment-na\u00efve patients managed with fixed-interval maintenance protocols, particularly from South-Eastern Europe, remain limited. This pilot study evaluated 24-month outcomes of intravitreal faricimab in treatment-na\u00efve nAMD and DME, using a standardized four-injection loading phase followed by fixed every-16-week (Q16W) maintenance. Materials and Methods: This study conducted a retrospective, observational, single-center pilot cohort study of 20 consecutive treatment-na\u00efve eyes (9 nAMD, 11 DME). All patients received four monthly loading injections followed by a fixed every-16-week (Q16W) maintenance schedule, supplemented by discretionary additional injections for residual or recurrent disease activity (215 injections total; mean 10.75 \u00b1 0.79 per patient; range 9\u201312). Primary outcomes were changes in central foveal thickness (CFT) and best-corrected visual acuity (BCVA; Snellen lines with ETDRS letter equivalents) at months 4 and 24. Prespecified secondary analyses included bootstrap 95% confidence intervals, a linear mixed-effects model with a time \u00d7 disease-group interaction, Bayesian credible intervals with weakly informative priors, false-discovery-rate (FDR) correction, and a minimum detectable effect-size analysis. Results: All 20 eyes completed 24-month follow-up. In nAMD, mean CFT decreased by 186.9 \u00b1 71.9 \u00b5m (35.9%; bootstrap 95% CI 148.1\u2013236.0; p &lt; 0.001; d = 2.60), and BCVA improved by 3.89 \u00b1 0.78 Snellen lines (~19 ETDRS letters; 95% CI 3.44\u20134.33; p &lt; 0.001; d = 4.97). In DME, CFT decreased by 197.7 \u00b1 65.7 \u00b5m (39.3%; 95% CI 162.5\u2013237.3; p &lt; 0.001; d = 3.01), and BCVA improved by 4.55 \u00b1 1.04 lines (~23 ETDRS letters; 95% CI 4.00\u20135.09; p &lt; 0.001; d = 4.39). All 20 eyes (100%) achieved \u2265 3 Snellen lines gain and \u226520% CFT reduction; 80% reached final BCVA \u2265 7 lines. A linear mixed-effects model showed a significant time effect (p &lt; 0.001) but no time \u00d7 group interaction (CFT p = 0.84; BCVA p = 0.51), indicating concordant trajectories across diseases. Bayesian analysis with weakly informative priors yielded posterior P(|d| &gt; 0.8) \u2265 0.99 for all primary outcomes. After FDR correction, all pre-specified primary comparisons remained significant. The minimum detectable effect size with the realized sample sizes (Cohen\u2019s d \u2248 0.66 combined, 1.07 nAMD, 0.94 DME at 80% power) was substantially below all observed effect sizes. No ocular or systemic adverse events were recorded. Conclusions: In this small, single-center, treatment-na\u00efve pilot cohort, a fixed Q16W faricimab maintenance schedule with discretionary additional injections was associated with durable anatomical and functional improvements over 24 months in both nAMD and DME, with no adverse events recorded across 215 injections. Given the limited sample, these findings should be regarded as hypothesis-generating. The high responder rates likely reflect the cohort\u2019s substantial baseline visual impairment (mean baseline BCVA ~20\/120\u201320\/200), which provides greater absolute capacity for measurable gain than in higher-acuity registration trial populations. These pilot data support fixed-interval faricimab as a logistically feasible candidate strategy in resource-constrained settings and should be confirmed in larger multicenter cohorts using standardized ETDRS acuity assessment.<\/jats:p>","DOI":"10.3390\/medicina62071307","type":"journal-article","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T12:01:37Z","timestamp":1783339297000},"page":"1307","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Faricimab for Treatment-Na\u00efve Neovascular AMD and Diabetic Macular Edema: 24-Month Outcomes from a Single-Center Pilot Cohort in South-Eastern Europe"],"prefix":"10.3390","volume":"62","author":[{"given":"Maja L. J.","family":"\u017divkovi\u0107","sequence":"first","affiliation":[{"name":"Ophthalmology Clinic, University Clinical Center Ni\u0161, Bulevar dr Zorana \u0110in\u0111i\u0107a 48, 18000 Ni\u0161, Serbia"},{"name":"Department of Ophthalmology, Faculty of Medicine, University of Ni\u0161, Bulevar dr Zorana \u0110in\u0111i\u0107a 81, 18000 Ni\u0161, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marko","family":"Zlatanovi\u0107","sequence":"additional","affiliation":[{"name":"Ophthalmology Clinic, University Clinical Center Ni\u0161, Bulevar dr Zorana \u0110in\u0111i\u0107a 48, 18000 Ni\u0161, Serbia"},{"name":"Department of Ophthalmology, Faculty of Medicine, University of Ni\u0161, Bulevar dr Zorana \u0110in\u0111i\u0107a 81, 18000 Ni\u0161, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2064-9520","authenticated-orcid":false,"given":"Nevena","family":"Zlatanovi\u0107","sequence":"additional","affiliation":[{"name":"Community Health Center Ni\u0161, Vojvode Tankosi\u0107a 15, 18000 Ni\u0161, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mladen","family":"Brzakovi\u0107","sequence":"additional","affiliation":[{"name":"Special Hospital for Ophthalmology \u201cClinic Maja\u201d, Vizantijski Bulevar 8, 18000 Ni\u0161, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihailo","family":"Jovanovi\u0107","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Faculty of Medicine, University of Kragujevac, Svetozara Markovi\u0107a 69, 34000 Kragujevac, Serbia"},{"name":"Ophthalmology Clinic, University Clinical Center Kragujevac, Zmaj Jovina 30, 34000 Kragujevac, Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e106","DOI":"10.1016\/S2214-109X(13)70145-1","article-title":"Global Prevalence of Age-Related Macular Degeneration and Disease Burden Projection for 2020 and 2040: A Systematic Review and Meta-Analysis","volume":"2","author":"Wong","year":"2014","journal-title":"Lancet Glob. 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