Atia Vision has received Investigational Device Exemption (IDE) approval from the FDA to begin a traditional feasibility clinical study of its OmniVu Lens System. This novel IOL is designed to restore dynamic range of vision following cataract surgery.

"This IDE approval marks a pivotal milestone in our mission to transform the standard of care for cataract patients," Mariam Maghribi, CEO of Atia Vision, said in a company news release. "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."

The OmniVu Lens System is comprised of two distinct components: a fluid-filled shape-changing base that provides focusing capability, or zoom function, and a front optic that docks into the base provides the optical power. Additionally, engineered with a more physiologic shape to fill the capsular bag, the OmniVu Lens System is expected to preserve the eye's anatomic integrity and elasticity. This advanced design aims to provide patients with a more natural visual experience across all distances that continues to perform over time.

The OmniVu Lens System has been evaluated internationally in both first-in-human and feasibility clinical trials with over 75 lenses implanted to date and follow-up extending to 3 years. Clinical results thus far demonstrate continuous range of focus from far through near with 100% of patients achieving 20/20 or better uncorrected distance vision. Preliminary contrast sensitivity and patient-reported outcomes data demonstrate the potential for parity with monofocal lenses, the current standard for visual quality after cataract surgery.