The FDA has granted Atia Vision, Inc. investigational device exemption (IDE) approval to initiate a traditional feasibility clinical study on its novel intraocular lens (IOL): the OmniVu Lens System.
First up: A refresher on Atia.
Headquartered in Campbell, California, Atia is a portfolio company of Shifamed LLC, a specialized medical technology (MedTech) innovation hub developing next-gen products.
Focusing on Atia: The privately-held medical device company is focused exclusively on developing its OmniVu Lens System for presbyopia vision correction.
Now to this IOL.
The OmniVu IOL System is a dual-optic IOL featuring a proprietary design with two integral components:
- Shape-changing, fluid-filled base that provides focusing capabilities (zoom function)
- Fixed-power front optic that docks into the base to supply optical power
And its purpose?
Restoring the full range of functional vision (near, intermediate, and distance visual acuity [VA]) while also:
- Preserving natural vision quality
- Minimizing visual disturbances for presbyopia patients
- Achieving refractive predictability
- Preserving the eye's anatomic integrity and elasticity
How does it work, exactly?
The IOL is delivered via “conventional surgical techniques”—in other words: conducting the typical IOL delivery used during cataract surgery.
What this involves: Positioning the IOL base into the capsular bag and then implanting the fixed optic before docking it into the base.
- For an in-action visual of the process, click here (and scroll down).
And what’s the difference between this IOL and others?
Traditional IOLs used during cataract surgery often come with their own visual drawbacks and side effects. For example:
- Monofocal IOLs → Sacrifice visual range and reduced contrast sensitivity for visual clarity
- Extended-depth-of-focus (EDOF) IOLs → Achieve extended, continuous vision but reduced image quality
- Trifocal IOL → Achieve broadest vision range but reduced image quality
Other side effects: Can include poor quality as well as incomplete range of vision and nighttime glare or halos.
- Notably: The OmniVu is intentionally designed to avoid generating visual disturbances such as glare, halos, or artifacts.
Nice! Now let’s talk about this IDE approval.
As a reminder: An IDE essentially allows an investigational device to be used in a clinical study so safety and effectiveness data can be collected.
- What this means for Atia: The company now has the green light to kick off a U.S.-based clinical trial on its novel IOL—bringing it one step closer to seeking regulatory clearance.
And as CEO Mariam Maghibi, MD, noted, this approval marks a “pivotal milestone” in the company’s mission to change the standard of care for cataract patients.
“OmniVu was developed to solve for the limitations of both accommodative and traditional lenses,” Maghibi stated. “Our technology represents a significant advancement in lens design by addressing both optical and functional compromises found in current solutions."
Any word on clinical trial details yet?
So far, no. The company disclosed no specific plans.
Well, in the meantime, what do we know about the OmniVu’s clinical performance?
A fair amount, so far. In fact, the IOL has undergone clinical evaluations across the globe in both first-in-human (FIH) and feasibility studies—with 75+ implantations thus far and follow-up data extending to 3 years.
Case in point: As we reported in May 2023, early results (3-month data) from a 12-month FIH trial (NCT05627700) suggested the OmniVu could be an impactful solution for both cataract and presbyopia correction.
Any other promising data thus far?
Atia noted positive findings indicate “continuous range of focus from far through near with 100% of patients achieving 20/20 or better uncorrected distance vision.”
And importantly: Based on preliminary contrast sensitivity and patient-reported outcomes data, the IOL has demonstrated a “potential for parity with monofocal lenses, the current standard for visual quality after cataract surgery.”