FDA Approves Atia Vision to Initiate U.S. Clinical Trial for OmniVu Lens System in Cataract Patients

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.

About the OmniVu Lens System

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.

Dual-Component Design

The OmniVu system consists of two key components:

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

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

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.

Clinical Validation and Global Experience

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.

Key Findings from Early Trials:

       • Demonstrated continuous range of focus from distance to near

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

       • 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

Executive Commentary

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

“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.”

Next Steps in the U.S.

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.