iVeena Delivery Systems has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IVMED-85, a novel eye drop therapy intended for the treatment of pediatric myopia.

iVeena Delivery Systems 宣布已向美国食品药品监督管理局 (FDA) 提交了 IVMED-85 的新药临床试验 (IND) 申请，这是一种用于治疗儿童近视的新型滴眼液疗法。

A Non-Atropine, Noninvasive Approach

非阿托品、非侵入性方法

IVMED-85 is a preservative-free, non-surgical, noninvasive, and non-atropine daily eye drop formulated to prevent the progression of myopia in children. As a new chemical entity (NCE), IVMED-85 functions through activation of lysyl oxidase (LOX), a mechanism aimed at strengthening scleral and corneal collagen crosslinks.

IVMED-85是一种不含防腐剂、非手术、非侵入性且不含阿托品的每日眼药水，旨在预防儿童近视的进展。作为一种新的化学实体（NCE），IVMED-85通过激活赖氨酰氧化酶（LOX）发挥作用，该机制旨在加强巩膜和角膜的胶原交联。

This effect is intended to reduce axial elongation and improve refractive outcomes..

这种效果旨在减少轴向伸长并改善屈光结果。

“Today’s announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option,” said Bala Ambati, MD, PhD, President and Founder of iVeena. “I am extremely proud of the remarkable commitment of the team at iVeena and look forward to initiating our multinational phase 2 study in the coming months.”.

“今天发布的公告是iVeena在为患者提供一种全新治疗选择的旅程中的重要里程碑，”iVeena总裁兼创始人Bala Ambati博士表示，“我为iVeena团队卓越的奉献精神感到无比自豪，并期待在接下来的几个月启动我们的跨国二期研究。”

Expert Perspective and Trial Plans

专家视角与试验计划

Vance Thompson, MD, Founder of Vance Thompson Vision in Sioux Falls, South Dakota, and Director of Refractive Surgery, emphasized the clinical relevance: “This IND marks a major step toward meeting a significant unmet need for patients. IVMED-85’s novel LOX-based mechanism offers a differentiated, non-atropine approach that could redefine how we treat pediatric myopia.”.

南达科他州苏福尔斯 Vance Thompson Vision 创始人、屈光手术主任 Vance Thompson 医学博士强调了其临床相关性：“这一新药临床试验申请标志着我们在满足患者重大未满足需求方面迈出了重要一步。IVMED-85 基于 LOX 的新颖机制提供了一种与众不同的非阿托品方法，可能会重新定义我们治疗儿童近视的方式。”

An IND submission to the FDA is required to obtain authorization for the initiation of clinical trials in human subjects. The FDA is expected to complete its review of the application within approximately 30 days. Subject to approval, iVeena plans to initiate the multinational phase 2 clinical trial of IVMED-85 in 2025..

向FDA提交IND申请是获得人体临床试验启动授权的必要条件。FDA预计将在大约30天内完成对申请的审查。在获得批准的前提下，iVeena计划于2025年启动IVMED-85的多国二期临床试验。