Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Background/aims To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).Design Prospective, double-masked, randomised, phase 3 trial.Methods Participants w...

Full description

Bibliographic Details
Main Authors:	Se Joon Woo, Srinivas R Sadda, Min Sagong, Cheolmin Yun, Edward Wylegala, Sunil Patel, Miroslav Veith, Jan Ernest, Jan Studnička, Attila Vajas, Inkyung Oh, Mario Bradvica, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár, Adrienne Csutak, Lajos Enyedi, Wooree Choi, Hyerin Jang
Format:	Article
Language:	English
Published:	BMJ Publishing Group 2023-06-01
Series:	BMJ Open Ophthalmology
Online Access:	https://bmjophth.bmj.com/content/8/1/e001561.full

Similar Items

Response to Aflibercept Therapy in Three Types of Choroidal Neovascular Membrane in Neovascular Age-Related Macular Degeneration: Real-Life Evidence in the Czech Republic
by: Jan Nemcansky, et al.
Published: (2019-01-01)

Transitioning from Aflibercept to Biosimilar Ranibizumab in Neovascular AMD (The TRANSFORM Trial): A Multicenter Observational Study
by: Chakraborty D, et al.
Published: (2024-06-01)

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product
by: Neungseon Seo, et al.
Published: (2024-03-01)

Safety of Intravitreal Injection of Biosimilar of Aflibercept in Rabbit Eyes
by: Alireza Lashay, et al.
Published: (2020-01-01)

Expert Panel Consensus for Optimizing Outcomes in Neovascular Age-Related Macular Degeneration in the Context of Suboptimal Response to a Biosimilar: The Role of Aflibercept
by: Narendran N, et al.
Published: (2024-11-01)

Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
by: Ryu G, et al.
Published: (2021-08-01)

Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product
by: Neungseon Seo, et al.
Published: (2024-11-01)

Efficacy and Safety of Biosimilar QL1207 vs. the Reference Aflibercept for Patients with Neovascular Age-Related Macular Degeneration: A Randomized Phase 3 Trial
by: Bing Li, et al.
Published: (2023-11-01)

Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma
by: Naris Kitnarong, et al.
Published: (2022-01-01)

Result of intravitreal aflibercept injection for myopic choroidal neovascularization
by: Shih-Lin Chen, et al.
Published: (2021-09-01)

Switch to Aflibercept in the Treatment of Neovascular AMD: Long-Term Results
by: Pedro Neves Cardoso, et al.
Published: (2017-01-01)

Lentiviral delivered aflibercept OXB-203 for treatment of neovascular AMD
by: Sharifah Iqball, et al.
Published: (2023-09-01)

12-month outcomes of ziv-aflibercept for neovascular age-related macular degeneration in eyes previously treated with aflibercept
by: Wajiha J Kheir, et al.
Published: (2025-01-01)

Intravitreal Faricimab for Aflibercept-Resistant Neovascular Age-Related Macular Degeneration
by: Rush RB, et al.
Published: (2022-12-01)

Intravitreal aflibercept for choroidal neovascularization associated with chorioretinitis: a pilot study
by: Korol AR, et al.
Published: (2017-07-01)

Intravitreal aflibercept for management of subfoveal choroidal neovascularization secondary to angioid streaks
by: Ebru Esen, et al.
Published: (2015-01-01)

Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea®)
by: Hangyeore Lee, et al.
Published: (2024-06-01)

Intravitreal Brolucizumab in Patients with Aflibercept-Resistant Neovascular Age-Related Macular Degeneration
by: Ashwin Gupta, et al.
Published: (2022-01-01)

Comparative effectiveness of aflibercept for the treatment of patients with neovascular age-related macular degeneration
by: Thomas M, et al.
Published: (2013-03-01)

Intravitreal aflibercept in neovascular age-related macular degeneration previously treated with ranibizumab
by: Rachel Hui Fen Lim, et al.
Published: (2017-03-01)

Twelve-week dosing with Aflibercept in the treatment of neovascular age-related macular degeneration
by: Garweg JG
Published: (2019-07-01)

Intravitreal aflibercept for choroidal neovascularization associated with chorioretinitis: a pilot study [Corrigendum]
by: Korol AR, et al.
Published: (2017-08-01)

Two-Year Outcome of Aflibercept for the Treatment of Choroidal Neovascularization in Punctate Inner Choroidopathy
by: Luis Arrevola, et al.
Published: (2019-01-01)

Meticulous multimodal analysis of aflibercept therapy for submacular vascularized pigment epithelial detachment associated with neovascular AMD in a prospective case series, the EVEN study
by: Clement K. Chan, et al.
Published: (2020-12-01)

Short-Term Comparison of Switching to Brolucizumab or Faricimab from Aflibercept in Neovascular AMD Patients
by: Akiko Kin, et al.
Published: (2024-07-01)

Bietti crystalline dystrophy complicated by choroidal neovascularization treated with a single dose of aflibercept
by: Merve Ozbek, et al.
Published: (2023-01-01)

Comparison of the effectiveness of various protocols for the transition to aflibercept with tachyphylaxis for ranibizumab in patients with neovascular AMD
by: A. N. Kulikov, et al.
Published: (2018-11-01)

Macular Hole Formation Following Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration
by: Yasmin Ali Said, et al.
Published: (2022-04-01)

Intravitreal aflibercept for the treatment of choroidal neovascularization associated with pathologic myopia: a pilot study
by: Korol AR, et al.
Published: (2016-11-01)

Tolerating subretinal fluid in the treatment of neovascular age-related macular degeneration with intravitreal aflibercept
by: Dilan Yildiz, et al.
Published: (2021-06-01)

Comparative study on the efficacy of Conbercept and Aflibercept in the treatment of neovascular age-related macular degeneration
by: Hao Xie, et al.
Published: (2024-05-01)

Intravitreal Aflibercept as a Rescue Therapy for Retinal Neovascularization and Macular Edema due to Eales Disease
by: Ning-Yi Hsia, et al.
Published: (2021-01-01)

Real-world efficacy and safety of 8 mg aflibercept in neovascular AMD: a case series
by: David A Eichenbaum, et al.
Published: (2025-02-01)

Efficacy of aflibercept in patients with neovascular age-related macular degeneration when combined with cataract surgery
by: A. A. Kuznetsov, et al.
Published: (2018-10-01)

Clinical Phenotypes of Patients with Neovascular Age-Related Macular Degeneration and Poor Response to Aflibercept Treatment
by: V. G. Likhvantseva, et al.
Published: (2022-10-01)

Antiproliferative, Apoptotic, and Autophagic Activity of Ranibizumab, Bevacizumab, Pegaptanib, and Aflibercept on Fibroblasts: Implication for Choroidal Neovascularization
by: Lyubomyr Lytvynchuk, et al.
Published: (2015-01-01)

Presumed Melanocytoma-Associated Choroidal Neovascular Membrane with Hemorrhage Successfully Treated with Intravitreal Aflibercept Injections
by: Austin S. Yu, et al.
Published: (2023-09-01)

One-Year Outcomes of Faricimab Treatment for Aflibercept-Resistant Neovascular Age-Related Macular Degeneration
by: Rush RB
Published: (2023-08-01)

A customized regimen of intravitreal aflibercept for the treatment of choroidal neovascularization secondary to different chorioretinal diseases
by: Magdy Moussa, et al.
Published: (2023-01-01)

Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration
by: Sam Razavi, et al.
Published: (2021-02-01)