A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-06-17 DOI:10.1080/14712598.2025.2519531

Hansjürgen Agostini, Kristine Baumane, Vilma Jūratė Balčiūnienė, Kaspars Ozols, Riken Soni, Sabrina Hamdi, Silvia Cirillo, Masna Rai, Hendrik Otto, Steffen Leutz, Abid Sattar, Fausto Berti

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引用次数: 0

Abstract

Background: This study compared efficacy, pharmacokinetics (PK), immunogenicity, and safety between AVT06, proposed biosimilar to reference product (RP) aflibercept (Eylea®), in participants with neovascular age-related macular degeneration (nAMD).

Methods: In this randomized, double-masked, multicenter, active-controlled trial, treatment naïve participants received intravitreal injections of AVT06 or RP (2 mg) over 48 weeks. The primary endpoint was the change from baseline to Week 8 in best-corrected visual acuity (BCVA). Secondary endpoints included BCVA improvements and changes in Central Subfield Thickness (CST). PK, immunogenicity, and safety were also assessed.

Results: The 90% and 95% confidence intervals (-0.60, 2.14 and -0.86, 2.40, respectively) in least squares mean difference in BCVA letter score from baseline to Week 8 were contained within the pre-specified equivalence margin of ETDRS BCVA letter score of [-3.5 to 3.5], supporting the demonstration of comparative efficacy. Secondary efficacy outcomes were also comparable. PK analyses supported systemic safety. There were no clinically meaningful differences in immunogenicity profiles. Safety profiles were similar; most treatment-emergent adverse events were mild and unrelated to the study drug.

Conclusions: Results supported a demonstration of comparable efficacy between AVT06 and RP aflibercept. Similar PK, immunogenicity, and safety profiles were also shown.

Clinical trial registration: ClinicalTrials.gov identifier is NCT05155293; ClinicalTrialsRegister.eu identifier is 2021-003651-42.

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一项随机、双盲、平行组、多中心临床研究，评估候选生物类似药AVT06与参比产品afliberceept在新生血管性年龄相关性黄斑变性患者中的疗效和安全性。

背景：本研究比较了AVT06在新生血管性年龄相关性黄斑变性（nAMD）患者中的疗效、药代动力学（PK）、免疫原性和安全性。AVT06是一种拟与参比产品（RP） afliberept （Eylea®）类似的生物仿制药。方法：在这项随机、双盲、多中心、主动对照试验中，治疗naïve参与者在48周内接受玻璃体内注射AVT06或RP （2 mg）。主要终点是从基线到第8周最佳矫正视力（BCVA）的变化。次要终点包括BCVA改善和中央子野厚度（CST）的变化。还评估了PK、免疫原性和安全性。结果：基线至第8周的BCVA信评分最小二乘平均差值的90%和95%置信区间（分别为-0.60、2.14和-0.86、2.40）均包含在预先规定的ETDRS BCVA信评分[-3.5 ~ 3.5]等效范围内，支持比较疗效的论证。次要疗效结果也具有可比性。PK分析支持系统安全性。在免疫原性方面没有临床意义的差异。安全概况相似；大多数治疗中出现的不良事件是轻微的，与研究药物无关。结论：结果支持AVT06和RP阿非利西普的疗效相当。相似的PK，免疫原性和安全性也显示。临床试验注册：ClinicalTrials.gov识别码为NCT05155293；ClinicalTrialsRegister。欧盟标识符是2021-003651-42。

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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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.