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Abstract：
BACKGROUND: SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).
METHODS: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.
RESULTS: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.
CONCLUSIONS: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.
BACKGROUND: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.
METHODS: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.
RESULTS: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.
CONCLUSIONS: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease.
BACKGROUND: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.
摘要：
背景：SB11（Byooviz™；三星BioepisCo.，Ltd.)是雷珠单抗(Lucentis®；Genentech，Inc.)用于治疗视网膜疾病的生物类似药靶向血管内皮生长因子A。SB11的预填充注射器（PFS）介绍为小瓶提供了一种替代的给药方法，具有增强安全性和有效注射器制备的潜力。这项研究的目的是评估医疗保健专业人员（HCP）按照使用说明准备和施用SB11PFS玻璃体内（IVT）注射给患有新生血管性年龄相关性黄斑变性（nAMD）或继发性黄斑水肿的患者视网膜静脉阻塞（RVO）。
方法：这项研究是一个开放标签，单臂,单剂量临床研究，以评估SB11PFS在nAMD或RVO继发黄斑水肿患者中的可用性。四个HCP制备并给予34例患者0.5mgSB11PFSIVT注射。产品使用任务完成情况(总共12个任务)由独立观察者进行评估。在注射研究产品后7天评估安全性。
结果：共纳入34例患者并完成研究。34例（100％）患者成功完成了所有12项任务，没有使用相关的失败。大多数患者（32名患者，94.1%)无不良事件(AE)，而2例(5.9%)患者出现3例治疗紧急AE(TEAE),严重程度为轻度至中度.在研究期间没有报告严重或严重的TEAE。
结论：这项研究表明，HCP能够通过IVT注射成功制备和施用SB11PFS。没有发现意外的安全问题。SB11PFS是在视网膜疾病患者中治疗性施用SB11的有希望的替代方案。
背景：ClinicalTrials.gov标识符NCT06176963；EudraCT编号2021-003566-12。
方法：这项研究是一个开放标签，单臂,单剂量临床研究，以评估SB11PFS在nAMD或RVO继发黄斑水肿患者中的可用性。四个HCP制备并给予34例患者0.5mgSB11PFSIVT注射。产品使用任务完成情况(总共12个任务)由独立观察者进行评估。在注射研究产品后7天评估安全性。
结果：共纳入34例患者并完成研究。34例（100％）患者成功完成了所有12项任务，没有使用相关的失败。大多数患者（32名患者，94.1%)无不良事件(AE)，而2例(5.9%)患者出现3例治疗紧急AE(TEAE),严重程度为轻度至中度.在研究期间没有报告严重或严重的TEAE。
结论：这项研究表明，HCP能够通过IVT注射成功制备和施用SB11PFS。没有发现意外的安全问题。SB11PFS是在视网膜疾病患者中治疗性施用SB11的有希望的替代方案。
背景：ClinicalTrials.gov标识符NCT06176963；EudraCT编号2021-003566-12。
