US FDA gives Atia Vision go-ahead to begin clinical study of the OmniVu Lens System

The dual-optic lens works beyond the capabilities of currently available presbyopia correcting lenses. Image credit: AdobeStock/Mohammed

Shifamed portfolio company Atia Vision has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a traditional feasibility clinical study of the company’s OmniVu Lens System, a novel intraocular lens for restoring dynamic range of vision following cataract surgery.¹ The dual-optic lens works beyond the capabilities of currently available presbyopia correcting lenses, according to a news release.

“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, in the 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 system utilizes 2 components consisting of a fluid-filled shape-changing base and a front optic that docks on the base. The fluid-filled base provides focusing capability, or zoom function, while the front optic provides optical power. The lens is also engineered with a more physiologic shape to fill the capsular bag, providing a potential to preserve the eye’s anatomic integrity and elasticity.¹ “This advanced design aims to provide patients with a more natural visual experience across all distances that continues to perform over time,” the release stated.

"The final frontier for lens surgery is an intraocular lens that combines outstanding distance vision with dynamic focusing that maintains excellent image quality," said George Waring, IV, MD, medical advisory board member for Atia Vision, in the release. "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."

The OmniVu system has previously been evaluated internationally in both first-in-human and feasibility clinical trials. To date, said clinical trials have facilitated the implantation of over 75 lenses and follow up of up to 3 years. Results from the trials have demonstrated continuous range of focus from far through near; 100% of patients achieved 20/20 or better uncorrected distance vision. Additionally, preliminary contrast sensitivity and patient-reported outcomes data demonstrate a potential for parity with monofocal lenses.¹

Reference:

1. FDA grants Atia Vision approval to begin US clinical trial of OmniVu Lens System in patients with cataracts. News release. Businesswire. May 20, 2025. Accessed May 21, 2025. https://www.businesswire.com/news/home/20250520015920/en/FDA-Grants-Atia-Vision-Approval-to-Begin-US-Clinical-Trial-of-OmniVu-Lens-System-in-Patients-with-Cataracts