Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis

Hazem Saleh Aljuhani,1,* Rahaf A Hubayni,2,3,* Jumanah Qedair,2,3 Ziad M Bukhari,4 Ahmed Alzahrani,4 Razan Osama Bawazir,2,3 Orjwan Salah Badghaish,2,3 Faisal Alqahtani5 1Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia; 2College of Medicine, King Saud bin...

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Main Authors: Aljuhani HS, Hubayni RA, Qedair J, Bukhari ZM, Alzahrani A, Bawazir RO, Badghaish OS, Alqahtani F
Format: Article
Language:English
Published: Dove Medical Press 2025-06-01
Series:Clinical Ophthalmology
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Online Access:https://www.dovepress.com/efficacy-and-safety-of-aflibercept-biosimilars-relative-to-reference-a-peer-reviewed-fulltext-article-OPTH
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author Aljuhani HS
Hubayni RA
Qedair J
Bukhari ZM
Alzahrani A
Bawazir RO
Badghaish OS
Alqahtani F
author_facet Aljuhani HS
Hubayni RA
Qedair J
Bukhari ZM
Alzahrani A
Bawazir RO
Badghaish OS
Alqahtani F
author_sort Aljuhani HS
collection DOAJ
description Hazem Saleh Aljuhani,1,* Rahaf A Hubayni,2,3,* Jumanah Qedair,2,3 Ziad M Bukhari,4 Ahmed Alzahrani,4 Razan Osama Bawazir,2,3 Orjwan Salah Badghaish,2,3 Faisal Alqahtani5 1Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia; 2College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia; 3King Abdullah International Medical Research Center, Jeddah, Saudi Arabia; 4Ophthalmology Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia; 5Vitreoretinal Division, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia*These authors contributed equally to this workCorrespondence: Hazem Saleh Aljuhani, Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia, Tel +966545254296, Email Aljuhanihazem@gmail.comPurpose: To assess the efficacy and safety of aflibercept biosimilars compared to reference aflibercept therapy for neovascular age-related macular degeneration (nAMD) through a systematic review and meta-analysis.Methods: A comprehensive literature search was conducted across multiple databases. Randomized controlled trials comparing intravitreal aflibercept biosimilars with reference aflibercept in patients with nAMD were included. The outcomes were changes in best-corrected visual acuity (BCVA), retinal thickness, choroidal neovascularization (CNV) leakage area from baseline based on fluorescein angiography, and adverse events.Results: Five studies involving 2,039 patients were included. No statistically significant differences were found between aflibercept biosimilars and reference aflibercept in terms of BCVA (weighted mean difference [WMD]: 1.05; 95% CI: − 0.62 to 2.71; p = 0.22), central subfield thickness (WMD: 3.33; 95% CI: − 14.48 to 21.14; p = 0.71), or CNV (WMD: − 0.23; 95% CI: − 0.58 to 0.12; p = 0.20). SThe incidence of treatment-emergent adverse events was similar between groups.Conclusion: Aflibercept biosimilars demonstrated comparable efficacy and safety profiles to reference aflibercept in the treatment of nAMD. These findings suggest that biosimilars may serve as a cost-effective alternative without compromising patient outcomes.Keywords: neovascular age-related macular degeneration, nAMD, aflibercept, biosimilars, anti-VEGF therapy, efficacy, safety
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series Clinical Ophthalmology
spelling doaj-art-8632f003db7c4c71997e7b22d165ec602025-08-20T03:32:36ZengDove Medical PressClinical Ophthalmology1177-54832025-06-01Volume 19Issue 119111918104064Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-AnalysisAljuhani HS0Hubayni RA1Qedair J2Bukhari ZM3Alzahrani A4Bawazir RO5Badghaish OS6Alqahtani F7Ophthalmology departmentCollege of MedicineCollege of MedicineOphthalmology DepartmentOphthalmology DepartmentCollege of MedicineCollege of MedicineVitreoretinal divisionHazem Saleh Aljuhani,1,* Rahaf A Hubayni,2,3,* Jumanah Qedair,2,3 Ziad M Bukhari,4 Ahmed Alzahrani,4 Razan Osama Bawazir,2,3 Orjwan Salah Badghaish,2,3 Faisal Alqahtani5 1Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia; 2College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia; 3King Abdullah International Medical Research Center, Jeddah, Saudi Arabia; 4Ophthalmology Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia; 5Vitreoretinal Division, King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia*These authors contributed equally to this workCorrespondence: Hazem Saleh Aljuhani, Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia, Tel +966545254296, Email Aljuhanihazem@gmail.comPurpose: To assess the efficacy and safety of aflibercept biosimilars compared to reference aflibercept therapy for neovascular age-related macular degeneration (nAMD) through a systematic review and meta-analysis.Methods: A comprehensive literature search was conducted across multiple databases. Randomized controlled trials comparing intravitreal aflibercept biosimilars with reference aflibercept in patients with nAMD were included. The outcomes were changes in best-corrected visual acuity (BCVA), retinal thickness, choroidal neovascularization (CNV) leakage area from baseline based on fluorescein angiography, and adverse events.Results: Five studies involving 2,039 patients were included. No statistically significant differences were found between aflibercept biosimilars and reference aflibercept in terms of BCVA (weighted mean difference [WMD]: 1.05; 95% CI: − 0.62 to 2.71; p = 0.22), central subfield thickness (WMD: 3.33; 95% CI: − 14.48 to 21.14; p = 0.71), or CNV (WMD: − 0.23; 95% CI: − 0.58 to 0.12; p = 0.20). SThe incidence of treatment-emergent adverse events was similar between groups.Conclusion: Aflibercept biosimilars demonstrated comparable efficacy and safety profiles to reference aflibercept in the treatment of nAMD. These findings suggest that biosimilars may serve as a cost-effective alternative without compromising patient outcomes.Keywords: neovascular age-related macular degeneration, nAMD, aflibercept, biosimilars, anti-VEGF therapy, efficacy, safetyhttps://www.dovepress.com/efficacy-and-safety-of-aflibercept-biosimilars-relative-to-reference-a-peer-reviewed-fulltext-article-OPTHNeovascular age-related macular degenerationnAMDafliberceptbiosimilarsanti-VEGF therapyefficacy
spellingShingle Aljuhani HS
Hubayni RA
Qedair J
Bukhari ZM
Alzahrani A
Bawazir RO
Badghaish OS
Alqahtani F
Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
Clinical Ophthalmology
Neovascular age-related macular degeneration
nAMD
aflibercept
biosimilars
anti-VEGF therapy
efficacy
title Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
title_full Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
title_fullStr Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
title_full_unstemmed Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
title_short Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
title_sort efficacy and safety of aflibercept biosimilars relative to reference aflibercept therapy for neovascular age related macular degeneration a systematic review and meta analysis
topic Neovascular age-related macular degeneration
nAMD
aflibercept
biosimilars
anti-VEGF therapy
efficacy
url https://www.dovepress.com/efficacy-and-safety-of-aflibercept-biosimilars-relative-to-reference-a-peer-reviewed-fulltext-article-OPTH
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