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: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2025-06-01
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| Series: | Clinical Ophthalmology |
| Subjects: | |
| 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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| Summary: | 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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| ISSN: | 1177-5483 |