Atia Vision receives FDA Approval to begin clinical trial of novel intraocular lens

OmniVue Lens System: ©Atia Vision

Atia Vision Inc., a portfolio company of the medical innovation hub Shifamed, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin a clinical feasibility study of its next-generation intraocular lens, the company announced.

The OmniVu Lens System is designed to restore a dynamic range of vision in patients undergoing cataract surgery, representing a technological leap beyond today’s presbyopia-correcting lenses. Cataracts are the leading cause of visual impairment globally, affecting an estimated 94 million people.

“This IDE approval marks a pivotal milestone in our mission to transform the standard of care for cataract patients,” said Mariam Maghribi, CEO of Atia Vision. “OmniVu was developed to solve for the limitations of both accommodative and traditional lenses.”

Unlike conventional static lenses that require patients to compromise between visual quality and range, the OmniVu system features a modular design with a fluid-filled, shape-changing base that provides a zoom function and a front optic that delivers optical power. The system is engineered to preserve the eye’s natural shape and flexibility, potentially offering a continuous range of vision from near to far.

According to George Waring IV, a medical advisory board member for Atia Vision, the device could represent a breakthrough in lens surgery. “The global outcomes to date demonstrate the real potential the OmniVu Lens System has to address the unanswered opportunities with current lens technology,” he said.

International trials of the OmniVu system, including over 75 lens implants with up to three years of follow-up, showed promising results. All patients achieved 20/20 or better uncorrected distance vision, and early data suggests the device may offer contrast sensitivity and patient satisfaction on par with monofocal lenses.

Presbyopia-correcting lenses currently account for just 6.2% of the market globally, in part due to trade-offs in visual clarity. Atia Vision aims to change that with a system that minimizes such compromises.

Innovation in intraocular lens technology and cataract care

In recent years, advances in intraocular lens technology have accelerated, aiming to deliver a full range of vision without sacrificing quality. Traditional IOLs—particularly monofocal lenses—remain the standard in cataract surgery, but they offer only a fixed focus point, requiring many patients to rely on glasses for near or intermediate vision.

This limitation spurred the development of presbyopia-correcting IOLs, including multifocal, extended depth of focus (EDOF), and accommodating lenses. However, adoption has been limited due to side effects such as glare, halos, and reduced contrast sensitivity. Many patients also find the benefits of these lenses to be inconsistent.

Emerging devices like Atia Vision’s OmniVu system represent a shift toward dynamic, physiologically integrated solutions. Other companies are also developing fluid- or mechanically-driven accommodating lenses that aim to restore youthful vision.

The integration of diagnostics and personalization is becoming more common. Wavefront-guided and light-adjustable lenses allow for individualized fine-tuning after surgery, which helps address issues like astigmatism or subtle refractive errors. Meanwhile, artificial intelligence is beginning to play a role in IOL power calculation and surgical planning, improving outcomes and reducing variability.

As Baby Boomers continue to age, demand for premium cataract solutions is expected to surge. Experts believe that next-generation IOLs could become the norm as the technology matures and reimbursement pathways become more favorable.