The US Food and Drug Administration (FDA) has cleared the first daily disposable soft contact lens for presbyopia that uses extended depth of focus (EDOF) optical design technology, enabling commercial distribution in the United States.
According to a Business Wire announcement, the Deseyne (vifilcon C) daily disposable soft (hydrophilic) contact lens for presbyopia has been developed by the Cataltheia Group and its US subsidiary, Bruno Vision Care LLC.
It said the lens was the first and only daily disposable contact lens for presbyopia to use patented EDOF technology.
Cataltheia Group co-founder and CEO Eddie Catalfamo said the FDA clearance represented a significant step forward in non-surgical presbyopia correction.
“We are proud to offer the first contact lens solution for the world’s aging population that delivers clear vision across all distances,” Catalfamo said. “With Deseyne, people can see clearly in the moments that matter without the trade-offs associated with multifocal lenses.”
Optometrist and researcher Dr Paul Karpecki said the lens offered a clinical advantage over existing designs.
“The Deseyne lens represents a clear clinical advantage over multifocal designs,” he said. “Its single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency.”
Dr Mark Bullimore described the lens as “a one-of-a-kind game-changer in presbyopia management”.
Until now, EDOF technology has been limited to intraocular lenses that require permanent surgical implantation.
Cataltheia Group said Deseyne extended comparable depth-of-focus benefits to a non-surgical contact lens format, with clinically meaningful improvements in near and intermediate vision. The FDA clearance is positioned as a major milestone for the estimated 1.8 billion people worldwide living with presbyopia.
Manufactured from vifilcon C hydrogel, Deseyne incorporates natural co-polymers, hyaluronic acid, and tamarind seed polysaccharide to support hydration, comfort, and visual stability throughout the day. As a daily disposable lens, it is associated with a lower risk of lens-related adverse events, with no adverse events reported in the clinical study cited in the announcement.
Salution Nexus president and CEO Dr Malvina Eydelman said the FDA clearance highlighted the role of regulatory strategy in advancing patient care.
“This milestone reflects how rigorous regulatory strategy can translate into real-world innovation – delivering meaningful advances in presbyopia care and expanding what people can see, do, and enjoy in everyday life,” Dr Eydelman said.
