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<p>This study aims to investigate efficacy and safety of ranibizumab biosimilars (Amelivu<sup>®</sup> and LucenBS<sup>®</sup>) across retinal diseases in Korean clinical practice. This retrospective, multicenter study enrolled 1153 eyes from 1075 patients across five centers in South Korea between May 2022 and October 2024. Patients received intravitreal ranibizumab biosimilars for neovascular age-related macular degeneration, retinal vein occlusion with macular edema, diabetic macular edema, and other retinal diseases. Treatment-naïve eyes comprised 408 cases (35.4%), while 745 eyes (64.6%) had prior anti-VEGF treatment. Amelivu was administered to 1007 eyes with 3.1 ± 1.9 injections over 10.2 ± 6.1&#xa0;months; LucenBS to 146 eyes with 3.1 ± 2.0 injections over 12.0 ± 4.9&#xa0;months. Amelivu demonstrated significant BCVA(logMAR) improvements from baseline (0.63 ± 0.62) to 12&#xa0;months (0.55 ± 0.61, P &lt; 0.01). LucenBS maintained logMAR VA from 0.64 ± 0.63 to 0.63 ± 0.68 at 12&#xa0;months (P = 0.40). Both biosimilars achieved significant CMT reductions through 12&#xa0;months: Amelivu from 398.0 ± 169.4&#xa0;μm to 323.0 ± 128.8&#xa0;μm (P &lt; 0.01); LucenBS from 368.7 ± 172.0&#xa0;μm to 306.0 ± 144.1&#xa0;μm (P &lt; 0.01). Treatment-naïve eyes showed superior CMT reduction (111.8&#xa0;μm) compared to previously treated eyes (53.5&#xa0;μm). Only one injection-related adverse event occurred: asymptomatic anterior chamber cells in the Amelivu group, resolving with topical treatment. Ranibizumab biosimilars demonstrated visual stabilization and significant anatomical improvements across retinal diseases with excellent safety profiles.</p>

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Real-world outcomes of ranibizumab biosimilars in various retinal diseases: a Korean multi-center experience—ROSE Korea Study

  • 期刊论文

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  • 发表日期：

    2026年1月9日

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  • Jae Ryong Song,
  • Un Chul Park,
  • Christopher Seungkyu Lee,
  • Jae Jin Cho,
  • Jin Young Kim,
  • Seung Chul Baek,
  • Areum Jeong,
  • Ashish Sharma,
  • Jae Hui Kim,
  • Min Sagong,
  • Se Joon Woo,
  • Baruch D. Kuppermann,
  • Anat Loewenstein,
  • Francesco Bandello,
  • Carl D. Regillo,
  • Luke Nicholson,
  • Clara Vazquez-Alfageme,
  • Nilesh Kumar,
  • Nikulaa Parachuri,
  • Seemantini Ayachit,
  • Alay Banker,
  • Kourous A. Rezaei,
  • Arshad M. Khanani,
  • Peter K. Kaiser,
  • Frank G. Holz,
  • Sobha Sivaprasad,
  • Taku Wakabayashi,
  • Giuseppe Querques,
  • Şengül Özdek,
  • Kodjikian Laurent,
  • Alper Bilgic,
  • Paolo Lanzetta,
  • Caroline R. Baumal,
  • Nancy Holekemp,
  • Taiji Sakamoto,
  • Adnan Tufail,
  • Nicolas Yannuzzi,
  • Giulia Corradetti,
  • Jay Sheth,
  • Chitaranjan Mishra,
  • Debdulal Chakraborty,
  • David Boyer,
  • Aleksandra Rachitskaya,
  • Tunde Peto,
  • Maximilian W. M. Wintergerst,
  • Valentina Sarao,
  • Barbara Parolini,
  • Khalil Ghasemi Falavarjani,
  • Quan Dong Nguyen,
  • Diana V. Do,
  • Pearse A. Keane,
  • Tarek Hassan,
  • Jayanth Sridhar,
  • David Eichenbaum,
  • Dilraj S. Grewal,
  • Francesc March,
  • Martin Spitzer,
  • Martin S. Zinkernagel,
  • Tomoko Ueda-Consolvo,
  • Masaaki Ishida,
  • Tomoko Nakamura,
  • Shuichiro Yanagisawa,
  • Kotaro Tsuboi,
  • Atsushi Hayashi,
  • Judy Kim

摘要

This study aims to investigate efficacy and safety of ranibizumab biosimilars (Amelivu® and LucenBS®) across retinal diseases in Korean clinical practice. This retrospective, multicenter study enrolled 1153 eyes from 1075 patients across five centers in South Korea between May 2022 and October 2024. Patients received intravitreal ranibizumab biosimilars for neovascular age-related macular degeneration, retinal vein occlusion with macular edema, diabetic macular edema, and other retinal diseases. Treatment-naïve eyes comprised 408 cases (35.4%), while 745 eyes (64.6%) had prior anti-VEGF treatment. Amelivu was administered to 1007 eyes with 3.1 ± 1.9 injections over 10.2 ± 6.1 months; LucenBS to 146 eyes with 3.1 ± 2.0 injections over 12.0 ± 4.9 months. Amelivu demonstrated significant BCVA(logMAR) improvements from baseline (0.63 ± 0.62) to 12 months (0.55 ± 0.61, P < 0.01). LucenBS maintained logMAR VA from 0.64 ± 0.63 to 0.63 ± 0.68 at 12 months (P = 0.40). Both biosimilars achieved significant CMT reductions through 12 months: Amelivu from 398.0 ± 169.4 μm to 323.0 ± 128.8 μm (P < 0.01); LucenBS from 368.7 ± 172.0 μm to 306.0 ± 144.1 μm (P < 0.01). Treatment-naïve eyes showed superior CMT reduction (111.8 μm) compared to previously treated eyes (53.5 μm). Only one injection-related adverse event occurred: asymptomatic anterior chamber cells in the Amelivu group, resolving with topical treatment. Ranibizumab biosimilars demonstrated visual stabilization and significant anatomical improvements across retinal diseases with excellent safety profiles.