Atia Vision, part of the Shifamed portfolio, has secured Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a feasibility clinical study for its OmniVu Lens System.
The intraocular lens is intended to enhance the dynamic range of vision post-cataract surgery, surpassing the capabilities of existing presbyopia-correcting lenses.
Atia Vision CEO Mariam Maghribi said: “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.”
The OmniVu Lens System consists of two main parts: a fluid-filled, shape-changing base that offers focusing ability, and a front optic that integrates with the base to deliver optical power.
Designed to fill the capsular bag with a more physiological shape, the system aims to maintain the eye’s anatomical structure and flexibility. This design seeks to provide a natural visual experience at various distances, with performance that endures over time.
Atia Vision medical advisory board member Dr George Waring, IV said: “The final frontier for lens surgery is an intraocular lens that combines outstanding distance vision with dynamic focusing that maintains excellent image quality.
“The global outcomes to date demonstrate the real potential the OmniVu Lens System has to address the unanswered opportunities with current lens technology, such as a continuous visual range, refractive predictability and stability, all while minimizing visual trade-offs.”
International evaluations of the OmniVu Lens System have included first-in-human and feasibility clinical trials, with over 75 lenses implanted and follow-up periods extending to three years.
Clinical outcomes indicate a continuous range of focus from far to near, with 100% of participants achieving 20/20 or better uncorrected distance vision.
Early data on contrast sensitivity and patient-reported outcomes suggest potential equivalence with monofocal lenses, which are currently the standard for visual quality following cataract surgery.
