Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration

IF 4.4 Q1 OPHTHALMOLOGY

Ophthalmology. Retina Pub Date : 2025-04-01 DOI:10.1016/j.oret.2024.10.001

Jan Hamouz MD , Agnieszka Nowosielska MD , Anna Święch-Zubilewicz MD , Santiago Abengoechea MD , Kristine Baumane MD , Attila Vajas MD , Małgorzata Siewierska MD , Milan Veselovsky MD , Miroslav Veith MD , Ágnes Kerényi MD , Shobhana Mange MD , Krishnapada Baidya MD , Guna Laganovska MD , Ignasi Jürgens MD , András Papp MD , Jignesh Gosai MD , Jana Štefanickova MD , Mei Han MD , Piotr Fryczkowski MD , Dominik Zalewski MD , Wenbin Wei MD

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Abstract

Objective

This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).

Design

This was a multicenter, double-masked, randomized, controlled phase III trial.

Participants

Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.

Methods

Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks.

Main Outcome Measures

The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between −3.49 and +3.49.

Results

Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, −2.23 to 0.13) and 95% CI (−2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.

Conclusions

QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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雷珠单抗生物类似物 QL1205 对新生血管性老年性黄斑变性的疗效和安全性：3期随机试验

研究目的本研究旨在证明生物仿制药QL1205与参考药物雷尼珠单抗（Lucentis®）在新生血管性年龄相关性黄斑变性（nAMD）患者中的临床等效性：这是一项多中心、双盲、随机对照的3期试验：方法、干预或测试：患者接受QL1205或参考雷尼单抗的玻璃体内注射，剂量为0.5毫克，每四周一次，共48周：主要终点是第8周时最佳矫正视力（BCVA）与基线水平相比的变化（以早期治疗糖尿病视网膜病变研究（ETDRS）字母表示）。QL1205与参考药物雷尼珠单抗的生物相似性以BCVA字母差异在-3.49和+3.49之间的等效范围进行评估：2019年6月27日至2021年6月8日期间，616名患者被随机分配到QL1205组（308人）和参考雷尼珠单抗组（308人）。第8周时，QL1205组BCVA的平均改善幅度为+6.3±9.13个ETDRS字母，参考雷尼单抗组为+7.3±8.82个ETDRS字母。两个治疗组之间差异的 90% 置信区间 (CI) [-2.23, 0.13] 和 95% CI [-2.46, 0.36]（P=0.1434）均在预定的等效范围内。两组患者的安全性均可控：结论：QL1205在治疗nAMD患者的临床疗效、眼部和全身安全性、免疫原性和药代动力学方面与参考药物雷尼珠单抗具有生物相似性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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