Atia Vision has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a traditional feasibility clinical trial of its innovative OmniVu Lens System in patients undergoing cataract surgery. The trial marks a major milestone in the company’s mission to advance intraocular lens (IOL) technology..

Atia Vision 已获得美国食品药品监督管理局 (FDA) 的研究设备豁免 (IDE) 批准，开始对其创新的 OmniVu 镜头系统在白内障手术患者中进行传统的可行性临床试验。这项试验标志着该公司推进人工晶状体 (IOL) 技术使命中的一个重要里程碑。

About the OmniVu Lens System

关于OmniVu镜头系统

The OmniVu Lens System is a novel intraocular lens designed to restore a dynamic range of vision—including near, intermediate, and distance—following cataract surgery. Unlike traditional monofocal or accommodative lenses, OmniVu integrates unique structural and functional advancements to address current limitations in IOL technology..

OmniVu镜片系统是一种新型的人工晶状体，旨在白内障手术后恢复包括近、中、远在内的动态视力范围。与传统的单焦点或调节性镜片不同，OmniVu集成了独特的结构和功能进步，以解决当前人工晶状体技术中的局限性。

Dual-Component Design

双组件设计

The OmniVu system consists of two key components:

OmniVu系统由两个关键组件组成：

• A fluid-filled, shape-changing base, which delivers the lens’ focusing (zoom) capability

充满液体、形状可变的基座，提供镜头的聚焦（变焦）功能

• A front optic that docks into the base, providing the necessary optical power

• 一个对接到基座的前部光学元件，提供必要的光学功率

This configuration is engineered to maintain the eye's natural anatomy and elasticity, offering a more physiologic fit within the capsular bag. The goal is to preserve the eye’s structure while delivering a seamless and natural visual experience across all distances—and sustaining this performance over time..

这种设计旨在保持眼睛的自然解剖结构和弹性，为囊袋提供更符合生理的适配。目标是在维持眼睛结构的同时，提供全距离无缝且自然的视觉体验，并且随着时间推移持续保持这种性能。

Clinical Validation and Global Experience

临床验证与全球经验

The OmniVu Lens System has already been evaluated in first-in-human and international feasibility trials, with over 75 lenses implanted to date and follow-up data extending up to three years.

OmniVu镜片系统已经在首次人体试验和国际可行性试验中进行了评估，迄今为止已植入超过75个镜片，随访数据最长达到三年。

Key Findings from Early Trials:

早期试验的主要发现：

• Demonstrated continuous range of focus from distance to near

• 展示了从远到近的连续对焦范围

• 100% of patients achieved 20/20 or better uncorrected distance vision

• 100%的患者达到了20/20或更好的未矫正远视力

• Preliminary contrast sensitivity and patient-reported outcomes indicate the potential to match or exceed the visual quality of monofocal lenses, the current gold standard post-cataract surgery

初步的对比敏感度和患者报告的结果表明，有可能匹配或超过目前白内障手术后单焦点镜片的视觉质量这一黄金标准。

Executive Commentary

管理层评论

Mariam Maghribi, CEO of Atia Vision, commented in the company’s press release:

玛丽亚姆·马格里比，Atia Vision的首席执行官，在公司的新闻稿中评论道：

“This IDE approval marks a pivotal milestone in our mission to transform the standard of care for cataract patients. OmniVu was developed to solve for the limitations of both accommodative and traditional lenses. Our technology represents a significant advancement in lens design by addressing both optical and functional compromises found in current solutions.”.

“这一 IDE 批准标志着我们在改变白内障患者护理标准的使命中迈出了关键的里程碑。OmniVu 的开发旨在解决调节型和传统型镜片的局限性。我们的技术通过应对当前解决方案中存在的光学和功能妥协，代表了镜片设计的重大进步。”

Next Steps in the U.S.

美国的下一步措施

With FDA IDE approval secured, Atia Vision will proceed with its U.S.-based traditional feasibility clinical study, building on the promising international data and aiming to further validate the OmniVu Lens System’s safety, effectiveness, and long-term durability.

随着FDA IDE批准的获得，Atia Vision将推进其基于美国的传统可行性临床研究，依托国际数据的良好前景，旨在进一步验证OmniVu镜头系统的安全性、有效性和长期耐用性。