FDA clears Deseyne disposable contact lens from Cataltheia Group

FDA Clears EDOF Daily Disposable Contact Lens for Presbyopia

EDOF optics move from IOLs to daily disposables, giving presbyopia care a new playbook.

The U.S. Food and Drug Administration (FDA) has cleared Deseyne (Bruno Vision Care/Cataltheia Group; Boca Raton, Florida, USA), a daily disposable soft contact lens for presbyopia. It’s the first FDA-cleared contact lens to incorporate extended depth of focus (EDOF) optical design, applying a technology long associated with intraocular lenses in a non-surgical, removable format. 

 

“We are proud to offer the first contact lens solution for the world’s aging population that delivers clear vision across all distances,” said Eddie Catalfamo, co-founder and CEO of Cataltheia Group, in a news release. “With Deseyne, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses.”

Designed to deliver continuous near, intermediate and distance vision through a single optical zone, the lens positions itself as an alternative to traditional multifocal contact lenses in presbyopia management. The clearance expands the range of optical strategies available to clinicians seeking non-surgical, daily disposable solutions.

READ MORE: Presbyopia on the Table: What Works, What’s Next

Regulatory clearance and clinical context

Deseyne is a daily disposable hydrophilic contact lens incorporating a patented EDOF optical architecture based on a hyper-refractive central zone. According to the company, this design redirects light in a controlled manner to extend depth of focus across multiple viewing distances without splitting light into discrete focal points.

From a clinical perspective, the FDA clearance introduces a new optical category into the presbyopia contact lens space. Rather than relying on concentric rings or segmented optics, Deseyne uses a single, spherical optical zone intended to preserve visual continuity and reduce the adaptation challenges commonly encountered with multifocal lenses.

“The Deseyne lens represents a clear clinical advantage over multifocal designs,” added Dr. Paul Karpecki, director of Cornea and External Disease at the Kentucky Eye Institute. “Its single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency.”

Lens materials and wear profile 

Deseyne is manufactured from vifilcon C hydrogel and incorporates natural co-polymers, hyaluronic acid and tamarind seed polysaccharide to support hydration and comfort throughout the day. As a daily disposable lens, it aligns with established safety expectations associated with single-use soft contact lenses.

READ MORE: IXI Unveils the World’s Lightest Smart Eyewear at 22g

Development timeline

The clearance follows an earlier regulatory milestone in April, when the base lens material and technology components used in Deseyne received FDA approval. That decision enabled the company to progress toward full product clearance and commercial readiness.

Historically, EDOF technology in ophthalmology has been limited to intraocular lenses requiring permanent implantation. Introducing this optical principle into a removable contact lens marks a shift in how depth-of-focus strategies may be applied in presbyopia care.

The takeaway 

With FDA clearance secured, Deseyne brings EDOF optics into the daily disposable contact lens market, offering optometrists a new presbyopia option rooted in established depth-of-focus principles and delivered without surgery.

Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.

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