ArticleEye (London, England)2025
FYB-201 Biosimilar ranibizumab (Ongavia/Ranivisio/Cimerli) Efficacy and Safety in Clinical Settings - FORCE study.
Article in Eye (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
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Who cites it
5 citing papers in PubMed.
- Real-World Utilization and Initial Experience with Aflibercept-ayyh (PAVBLUOphthalmology and therapy · 2026Article
- Real-world effectiveness and safety of ranibizumab biosimilar FYB-201 in Saudi Arabia (Ravegza) and Jordan (Uptera): a middle eastern extension of the FORCE study.Eye (London, England) · 2026Article
- Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study.Scientific reports · 2026Article
- Anti-vascular endothelial growth factor therapy for posterior segment diseases: Progress, challenges, and the road ahead.Indian journal of ophthalmology · 2026Review
- Article
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo understand the early experience of ranibizumab biosimilar (FYB 201) that has been approved in the United Kingdom (Ongavia, Teva Pharmaceuticals, Tel Aviv Israel), United States (Cimerli, Sandoz Inc, Princeton, NJ, USA) and Europe (Ranivisio, Bioeq AG, Zug, Switzerland).
methods1230 patients received 3595 ranibizumab biosimilar (FYB 201) injections for variable indications in this multicentric retrospective study. All patients were treated with at least one intravitreal injection of ranibizumab biosimilar (FYB 201) 0.5 mg. Primary outcome was best-corrected visual acuity (BCVA). Secondary outcome was central foveal thickness (CFT). Other outcome measures included adverse events.
resultsA total of 3595 ranibizumab biosimilar (FYB 201) injections were given for neovascular age-related macular degeneration (n-AMD) (n = 802), other causes of choroidal neovascularization (CNV) (n = 36), diabetic macular oedema (DMO) (n = 169), retinal vein occlusion (RVO) (n = 155), myopic macular neovascularisation (m-MNV) (n = 61), cystoid macular oedema (CMO) (n = 6) and proliferative diabetic retinopathy (n = 1). Mean age was 77.2 ± 12.7 years and 80.9% were females. The mean follow-up period was 15.7 ± 9.9 weeks after the first injection of ranibizumab biosimilar (FYB 201). Overall, the mean BCVA remained stable from 0.57 ± 0.21 at baseline to 0.56 ± 1.8 at the last follow-up (p = 0.84, 95% CI -0.0915 to 0.1115). The mean CFT was significantly reduced from 260.5 ± 141.8 μm at baseline to 211.4 ± 113.2 μm at the last follow-up (p = 0.0001, 95% CI 38.935 to 59.265). Three eyes (0.24%) had ocular adverse events and 6 patients (0.48%) experienced systemic adverse events during the study period.
conclusionRanibizumab biosimilar (FYB 201) injections were effective and safe in this real-world experience, with stable visual acuity and reduced CFT with no major complications.
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