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FDA clears first EDOF contact lens for presbyopia

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6 min read

Bruno Vision Care LLC announced the FDA approval of its Deseyne (vilfilcon C) daily disposable contact lens with patented technology.

The big picture: This clearance marks the first for a daily disposable, extended depth-of-focus (EDOF) lens targeting presbyopia correction—and requiring no patient cognitive adaptation period.

First, let’s get a look at this company.

Established in 2019 as the U.S. subsidiary of the Cataltheia Group—a medical innovation ecosystem targeting the advancement of biomimetic technologies—Bruno Vision Care is a vision health technology company based in Boca Raton, Florida.

Its focus: Extends to developing advanced soft contact lenses designed to deliver comfort and visual clarity—starting with its newly-approved Deseyne contact lens.

Wait a second … didn’t this lens already receive FDA approval last year?

It did receive regulatory clearance—but not for its EDOF optical design.

See here for details on that April 2025 approval.

Gotcha. So what's different about this presbyopia-targeting version?

That would be its EODF components, in which the Deseyne daily disposable contact lens utilizes an EDOF optical design engineered to “increase depth of focus without relying on multiple optical zones.”

Specifically: The lens’s EDOF technology offers an optical approach for presbyopic correction that doesn’t rely on accommodation or multiple optical zones (as are associated with traditional multifocal [MF] optics).

  • Plus: The lens is reported to deliver a DOF comparable to that provided by EDOF intraocular lenses (IOL) approved by the FDA—but without the need for permanent surgical implantation.

Explain the mechanics behind this.

At the lens’s core is a small, on-axis hyper-refractive central zone that:

  • Redirects light in a controlled manner
  • Prevents axial and paraxial light from contributing to retinal image formation—reportedly “redefining how clarity is constructed,” according to Bruno

So what type of wear experience should patients expect?

The expectation: For Deseyne’s EDOF technology to deliver smooth, continuous focus across all distance ranges (near, intermediate, and distance) for a clear and natural vision experience.

  • And with this, patients experience a “stable, high-contrast image” with crisp edges in all lighting conditions—including low light—thanks to 90% of incoming light being directed to the object of focus (regardless of pupil size).

In addition: The lens is intended to actively support sustained hydration, comfort, and visual stability throughout the day.

Explain how this is possible.

Via a few key components embedded within the lens—starting with Bruno’s proprietary “breakthrough” soft contact lens technology that integrates two patented innovations:

  • Vilfilcon C lens consisting of a unique, enriched hydrogel material formulated to hold water and bioactive molecules
  • FusionTechnology delivery system that embeds natural bio-copolymers, hyaluronic acid (HA), and tamarind seed polysaccharide into the lens material (for hydration) during the manufacturing process
    • These substances act as natural tear film components to promote hydration and comfort

Take note: Both technologies were cleared by the FDA in October 2024.

Go on …

Also, during the manufacturing process, bioactive substances referred to as “lachryceuticals” (encompassing amino acids, vitamins, and polysaccharides) are embedded within the lens matrix.

So when the lens is placed on a patient’s eye: A patented controlled-release mechanism enables the gradual delivery of lachryceuticals from the lens to the anterior segment.

  • The intent: To ensure the “bioavailability of these substances during the wear period for natural, long-lasting comfort,” according to the company.

Next: Talk about Deseyne’s safety profile.

Per Bruno, the lens offers a safety profile associated with a “lower risk of lens-related adverse events (AEs)”—in fact, no AEs were reported in clinical research.

And while on that subject: The company further reported that its Deseyne lenses demonstrated “clinically meaningful improvements across multiple visual performance metrics” versus a control lens. Among those metrics:

  • Distance-corrected DOF
  • Intermediate acuity
  • Near acuity
  • Mesopic contrast sensitivity

Any feedback from clinical experts on this lens?

Indeed. For instance, Paul Karpecki, OD, FAAO, director of Cornea and external Disease at the Kentucky Eye Institute, noted Deseyne’s design as a “clear clinical advantage over MF designs.”

  • “Its single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency,” he stated.

Take note: Dr. Karpecki was reportedly previously involved in a U.S. feasibility study on the lens.

Nice! Now, what do we know about its commercialization plans?

No specific timeframe as of yet. However, Bruno did share that its U.S. launch plans have been supported by Salution Nexus (a global regulatory and clinical strategy firm).

And outside of the U.S.: The lens is already available throughout Europe under the Safilens brand.