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KSI-301:一种用于视网膜疾病的研究性抗血管内皮生长因子生物聚合物偶联物。

KSI-301: an investigational anti-VEGF biopolymer conjugate for retinal diseases.

作者信息

Stern Hudson D, Hussain Rehan M

机构信息

Retina Associates Ltd, IL, Elmhurst, USA.

Division of Ophthalmology, Chicago, Cook County Health, IL, United States.

出版信息

Expert Opin Investig Drugs. 2022 May;31(5):443-449. doi: 10.1080/13543784.2022.2052042. Epub 2022 Mar 16.

Abstract

INTRODUCTION

KSI-301 is an intravitreal anti-vascular endothelial growth factor (VEGF) agent in clinical trials for the treatment of neovascular age-related macular degeneration (nAMD), diabetic retinopathy, diabetic macular edema (DME), and retinal vein occlusion (RVO). Its antibody-biopolymer conjugate structure is designed to decrease clearance from the eye and increase the duration of the effect.

AREAS COVERED

This article briefly discusses the impact and mechanisms of nAMD, DME, and RVO and evaluates currently approved anti-VEGF therapies. It progresses to examine a new agent, KSI-301 and the results from numerous clinical trials in these disease areas.

EXPERT OPINION

Despite varied results in the phase 2b/3 study for nAMD, there is potential for KSI-301 to serve as a durable therapy for VEGF-mediated retinal disorders. Ongoing phase 3 trials for nAMD, DME, and RVO will provide additional evidence on its efficacy, duration, and safety profiles.

摘要

引言

KSI-301是一种玻璃体内注射的抗血管内皮生长因子(VEGF)药物,正在进行治疗新生血管性年龄相关性黄斑变性(nAMD)、糖尿病性视网膜病变、糖尿病性黄斑水肿(DME)和视网膜静脉阻塞(RVO)的临床试验。其抗体-生物聚合物偶联结构旨在减少药物从眼部的清除并延长作用持续时间。

涵盖领域

本文简要讨论了nAMD、DME和RVO的影响及机制,并评估了目前已获批的抗VEGF疗法。进而探讨了一种新药KSI-301以及在这些疾病领域众多临床试验的结果。

专家观点

尽管在nAMD的2b/3期研究中结果各异,但KSI-301有潜力成为治疗VEGF介导的视网膜疾病的长效疗法。正在进行的针对nAMD、DME和RVO的3期试验将为其疗效、作用持续时间和安全性提供更多证据。

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