Atia’s OmniVu shows 36‑month gains

Atia Vision reported three-year follow-up data for its OmniVu Lens System in April, giving surgeons a longer look at an experimental cataract implant designed to address presbyopia as well as distance vision. The company presented the results at the 2026 American Society of Cataract and Refractive Surgery meeting, where William F. Wiley of Cleveland Eye Clinic delivered the data from the first-in-human study. (businesswire.com) The device is not a standard monofocal lens. OmniVu is a modular, shape-changing intraocular lens system intended to provide a continuous range of vision after cataract surgery, rather than forcing the usual trade-offs between distance, intermediate and near performance. (businesswire.com) Atia has described it as a dual-optic system, and the company said the design aims to preserve more natural visual function after implantation. (atiavision.com) The 36-month dataset comes from a small early cohort, and that matters when reading the results. Atia’s April 14 release said the prospective, multicenter, open-label first-in-human study enrolled 19 subjects and 29 eyes, including 10 binocular and 9 monocular implants. Ophthalmology Times, citing the same presentation, described a 10-patient, 14-eye cohort of cataract patients aged 60 to 87 with 36-month follow-up. (businesswire.com) The discrepancy appears to reflect different subsets or reporting cuts, but both accounts describe an early, noncomparative study rather than a pivotal trial. At 36 months, the headline number was distance vision. Atia said mean binocular uncorrected distance visual acuity was -0.11 logMAR, or about 20/16, while mean best-corrected distance visual acuity was -0.17 logMAR, or about 20/12. The company also reported mean binocular uncorrected intermediate acuity of -0.05 logMAR, about 20/20, and mean binocular uncorrected near acuity of 0.06 logMAR, about 20/25. (businesswire.com) Ophthalmology Times reported similar binocular outcomes of about 20/17 at distance, 20/18 at intermediate and 20/26 at near. Refractive stability is the other part of the story. Atia said manifest refraction spherical equivalent stayed within plus or minus 0.50 diopters throughout 36 months of follow-up, with refractive cylinder also stable over time. Defocus testing showed 20/32 or better vision over roughly 5.0 diopters of continuous defocus, according to the company’s presentation summary. (businesswire.com) Safety signals in the reported follow-up were limited, based on the company’s account. Atia said only one YAG capsulotomy was performed across all eyes and study visits, and no lens exchanges or refractive enhancements were required. A six-month contrast-sensitivity sub-study showed mesopic performance comparable to published monofocal intraocular lens literature, the company said. Wiley said in a statement that surgeons have had to accept trade-offs with presbyopia-correcting lenses and that the three-year OmniVu data showed “continuous focus from far to near, stable lens position, and remarkably low YAG rates” over that period. (businesswire.com) May 20, 2025 is the next concrete milestone in the program’s timeline. Atia said then that the U.S. Food and Drug Administration granted an Investigational Device Exemption to begin a traditional feasibility clinical study of OmniVu in cataract patients, after international first-in-human and feasibility work that the company said had included more than 75 implanted lenses. (businesswire.com) That U.S. study is the named next step after the three-year first-in-human readout. (atiavision.com)