Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study

This multicenter, retrospective real-world study evaluated the efficacy and safety of aflibercept 2 mg biosimilar SB15 (Afilivu®) across multiple retinal diseases. A total of 1083 eyes from 984 patients received 2762 injections between March 2023 and February 2025 at three South Korean tertiary centers, comprising 188 treatment-naïve (17.4%) and 895 switching eyes (82.6%). Diagnoses included neovascular age-related macular degeneration (nAMD, n = 611), retinal vein occlusion (RVO, n = 182), diabetic macular edema (DME, n = 173), and other conditions (n = 117). Over a mean follow-up of 5.17 ± 2.76 months with 2.55 ± 1.09 injections, central foveal thickness decreased significantly by - 47.5 µm (95% CI - 55.2 to - 39.8; P < 0.001), while best-corrected visual acuity remained stable (mean change - 0.003 LogMAR; P = 0.572). Treatment-naïve eyes demonstrated greater anatomical improvement than switching eyes (- 93.9 vs. - 37.9 µm; P < 0.001). Retinal fluid resolved significantly across diagnostic groups: in nAMD, subretinal fluid decreased from 51.2 to 29.6% (P < 0.001); in RVO, intraretinal fluid reduced from 92.9 to 76.4% (P < 0.001); and in DME, intraretinal fluid decreased from 90.8 to 84.4% (P = 0.002). One case (0.09%) of rhegmatogenous retinal detachment occurred; no intraocular inflammation or other serious adverse events were observed. These findings support the real-world effectiveness and safety of SB15 (Afilivu®) in both treatment-naïve and switching populations across diverse retinal diseases.

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Journal
Scientific Reports
Published
2026-06-12
DOI
https://doi.org/10.1038/s41598-026-52212-4
Primary Topic
Retinal Diseases and Treatments
Type
article
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article

Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study

DS Boyer, Adnan Tufail, Jehwi Jeon, Peter K. Kaiser et al.
Scientific Reports
Retinal Diseases and Treatments
article

Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study

DS Boyer, Adnan Tufail, Jehwi Jeon, Peter K. Kaiser, K. Laurent, Paolo Lanzetta, C H Lee, Valentina Sarao, Shuichiro Yanagisawa, Tomoko Ueda‐Consolvo, Nikulaa Parachuri, Khanani AM, Debdulal Chakraborty, Clara Vázquez-Alfageme, Caroline R. Baumal, Judy Kim, N Di Girolamo RK Kumar, Kourous A. Rezaei, Seung Chul Baek, Francesc March, Francesco Bandello, Nancy Holekemp, Jayanth Sridhar, Martin Spitzer, Nicolas Yannuzzi, Giulia Corradetti, Diana V. Do, Alper Bilgic, Şengül Özdek, Luke Nicholson, Jay Sheth, Carl Regillo, Dilraj S. Grewal, David Eichenbaum, Aleksandra Rachitskaya, Alay Banker, Martin S. Zinkernagel, Maximilian W. M. Wintergerst, Se Joon Woo, Sobha Sivaprasad, Taku Wakabayashi, Masaaki Ishida, Barbara Parolini, Atsushi Hayashi, Anat Loewenstein, Ashish Sharma, Tarek Hassan, Taiji Sakamoto, Kotaro Tsuboi, Quan Dong Nguyen, Khalil Ghasemi Falavarjani, Tunde Peto, Baruch D. Kuppermann, Tomoko Nakamura, Chitaranjan Mishra, Giuseppe Querques, Pearse A. Keane, Min Sagong, International Retina Biosimilar Study Group (Inter BIOS Group), Frank G. Holz, Jae Ryong Song
article en

Abstract

This multicenter, retrospective real-world study evaluated the efficacy and safety of aflibercept 2 mg biosimilar SB15 (Afilivu®) across multiple retinal diseases. A total of 1083 eyes from 984 patients received 2762 injections between March 2023 and February 2025 at three South Korean tertiary centers, comprising 188 treatment-naïve (17.4%) and 895 switching eyes (82.6%). Diagnoses included neovascular age-related macular degeneration (nAMD, n = 611), retinal vein occlusion (RVO, n = 182), diabetic macular edema (DME, n = 173), and other conditions (n = 117). Over a mean follow-up of 5.17 ± 2.76 months with 2.55 ± 1.09 injections, central foveal thickness decreased significantly by - 47.5 µm (95% CI - 55.2 to - 39.8; P < 0.001), while best-corrected visual acuity remained stable (mean change - 0.003 LogMAR; P = 0.572). Treatment-naïve eyes demonstrated greater anatomical improvement than switching eyes (- 93.9 vs. - 37.9 µm; P < 0.001). Retinal fluid resolved significantly across diagnostic groups: in nAMD, subretinal fluid decreased from 51.2 to 29.6% (P < 0.001); in RVO, intraretinal fluid reduced from 92.9 to 76.4% (P < 0.001); and in DME, intraretinal fluid decreased from 90.8 to 84.4% (P = 0.002). One case (0.09%) of rhegmatogenous retinal detachment occurred; no intraocular inflammation or other serious adverse events were observed. These findings support the real-world effectiveness and safety of SB15 (Afilivu®) in both treatment-naïve and switching populations across diverse retinal diseases.

Scientific Reports
Université Claude Bernard Lyon 1 (FR), Kagoshima University (JP), Roche (Switzerland) (CH), University of Bern (CH), Tufts University (US), Queen's University Belfast (GB), University of Udine (IT), Centre National de la Recherche Scientifique (FR), Bern University of Applied Sciences (CH), Cleveland Clinic (US), Moorfields Eye Hospital NHS Foundation Trust (GB), University of Nevada, Reno (US), University of Bonn (DE), Universität Hamburg (DE), Aichi Medical University (JP), Duke University (US), Oakland University (US), Yonsei University (KR), University of California, Irvine (US), Universitat de Girona (ES), University Hospital Bonn (DE), Tel Aviv Sourasky Medical Center (IL), Severance Hospital (KR), Islamic Azad University Medical Branch of Tehran (IR), University Hospital of Bern (CH), Aditya Jyot Eye Hospital (IN), Dubai Hospital (AE), Seoul National University Hospital (KR), Seoul National University Bundang Hospital (KR), NIHR Moorfields Biomedical Research Centre (GB), Aster (IT), Hôpital de la Croix-Rousse (FR), Berner Augenklinik am Lindenhofspital (CH), Doheny Eye Institute (US), Associated Retinal Consultants (US), Hospices Civils de Lyon (FR), University Medical Center Hamburg-Eppendorf (DE), Matériaux Ingénierie et Science (FR), Martini-Klinik (DE), Klinik und Poliklinik für Augenheilkunde Universitätsklinikum Regensburg (DE), Retina Vitreous Associates Medical Group (US), Minamiaoyama Eye Clinic (JP), Kingston Hospital (GB), Yeungnam University Medical Center (KR), Moorfields Eye Hospital (GB), Retina Vitreous Associates of Florida (US), Illinois Retina Associates (US), St. Anna Hospital (DE), Cleveland Eye Clinic (US), Sierra Eye Associates (US), University of Toyama (JP), University College London (GB), Institut National des Sciences Appliquées de Lyon (FR), Yeungnam University (KR), Smith-Kettlewell Eye Research Institute (US), University of Otago (NZ), The University of Texas Southwestern Medical Center (US), Wills Eye Hospital (US), Gazi University (TR), Stanford University (US)
Korea Health Industry Development Institute, Advanced Research Projects Agency
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Retinal Diseases and Treatments
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