Atia Vision Inc. has released the first-in-human clinical data from an ongoing 12-month trial on its patent OmniVu intraocular lens (IOL) System.
Give me some background on Atia.
Atia Vision is a privately-held medical device company centered around developing an accommodating IOL for presbyopia vision correction.
Atia is a portfolio company of Shifamed LLC, a specialized medical technology innovation hub focused on building next-generation products.
Now talk about this IOL system.
The OmniVu IOL System includes a fluid-filled, shape-changing base intended to provide clear vision (near to far) with a fixed-power front optic, enabling eyecare professionals (ECPs) to pick the appropriate lens according to patients’ target refraction.
What else does it do?
The system delivers a premium solution to potentially restore the full range of functional vision (improving near, intermediate, and distance visual acuity [VA]) and preserve cataract patients’ natural vision quality—all without generating visual disturbances like glares, halos, or artifacts.
Let’s talk about the research.
This new data is based on an ongoing prospective, non-randomized, open-label, 12-month trial (NCT05627700) assessing the use of the OmniVu IOL System on 13 patients (ages 50+) with visually significant cataracts who received surgery via a 3.5 mm sutureless corneal incision.
The following were measured before and 1, 3, 6, and 12 months following surgery: best-corrected distance visual acuity (BCDVA), distance-corrected intermediate visual acuity(DCIVA), and distance-corrected near visual acuity (DCNVA).
Results?
As of September 2022, the 3-month monocular data showed a stable refraction within ±0.5D of plano in 89% of patients.
The means (±SD) for each measurement are as follows:
- BCDVA = -0.02 (±0.07) logMAR (20/19)
- DCIVA = 0.01 (±0.10) logMAR (20/20)
- DCNVA = 0.22 (±0.11) logMAR (20/33)
Additionally, the mean defocus curve observed a VA better than 20/32 over the range of 0 to -1.5D.
Any side effects?
According to Atia, symptom assessment reports noted one patient exhibited a positive dysphotopsia.
Takeaway?
Given the patient-majority satisfaction and favorable safety profile, the early data suggests the IOL system could be impactful as a solution for both cataract and presbyopia correction.
What else to know?
According to Clinical Trials, the study is expected to conclude in December 2023. In the meantime, Atia is planning to release more recent data from patients’ post-surgery visits, including data from a second study center, during the ASCRS 2023 meeting in San Diego on May 5-8, 2023. So stay tuned!