ArticleOphthalmology and therapy2024
Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.
Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
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Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.
- Clinical efficacy and safety of anti-VEGF biosimilars compared to reference anti-VEGF agents for neovascular age-related macular degeneration: a systematic review, meta-analysis, and meta-regression.International ophthalmology · 2026Pooled it
- Ranibizumab biosimilars vs. reference Ranibizumab for neovascular age-related macular degeneration: a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Pooled it
- Biosimilar anti-vascular endothelial growth factor agents: Clinical outcomes, safety, and cost-effectiveness in India.Indian journal of ophthalmology · 2026Review
- Anti-vascular endothelial growth factor therapy for posterior segment diseases: Progress, challenges, and the road ahead.Indian journal of ophthalmology · 2026Review
- A Phase III Randomized Trial Comparing Efficacy, Safety, and Immunogenicity of ZRC-3285 vs. EyleaOphthalmology and therapy · 2026Article
- Real-World Analysis of Switching Between Ranibizumab Biosimilars: Safety and Results - a Multicenter Retrospective Observational Study.Clinical ophthalmology (Auckland, N.Z.) · 2026Article
- Quantitative Assessment of En‑face OCT‑Derived Minimum Intensity Fluid Changes Following Ranibizumab Biosimilar Therapy in Macular Neovascularization Secondary to nAMD and PCV.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
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Corrections and comments
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Authors and funding
26 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
methodsThis prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun's ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses).
resultsPrimary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun's ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at -1% (-2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun's ranibizumab group and 37% of the reference ranibizumab group (p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun's ranibizumab group and 14.6 letters in the reference ranibizumab group (p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups (p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated.
conclusionSun's ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns.
trial registrationCTRI/2020/09/027629, registered on 07 September 2020.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.