The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC has secured U.S. Food and Drug Administration (FDA) clearance for the first and only daily disposable soft (hydrophilic) contact lens for presbyopia. The lenses feature patented Extended Depth of Focus (EDOF) optical design technology, thus enabling U.S. commercial distribution.

“We are proud to offer the first contact lens solution for the world’s aging population that delivers clear vision across all distances,” Cataltheia Group Co-Founder/CEO Eddie Catalfamo stated. “With Deseyne, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses. “We thank Cataltheia’s co-founder, Vincenzo Bruno, the FDA team of expert scientists who evaluated our patented technology, our U.S. team, the Safilens’ team, our italian general manager, Daniele Bazzocchi, and the leaders who guided our FDA clearance as we set a new standard in presbyopia care and patient health.”

Deseyne delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. Such vision is achieved through Cataltheia’s patented hyper-refractive central zone, which is engineered to precisely redirect light in a controlled manner, according to the company. The result is a clear clinical advantage over the only other available contact lens option for presbyopia—multifocal lenses—which rely on multiple optical zones and often require prolonged visual and cognitive adaptation.

“The Deseyne lens represents a clear clinical advantage over multifocal designs,” Paul Karpecki, O.D., said. “Its single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency.”

Until now, Extended Depth of Focus technology has been limited to intraocular lenses requiring permanent surgical implantation. Deseyne extends these benefits to a non-surgical format, delivering a depth of focus comparable to FDA-approved EDOF intraocular lenses, with clinically meaningful improvements in near and intermediate vision. The FDA’s clearance marks a significant advance for the estimated 1.8 billion people worldwide living with presbyopia.

“The Deseyne lens is a one-of-a-kind game changer in presbyopia management,” said Mark Bullimore, FCOptom, Ph.D.

This FDA milestone builds on more than a decade of real-world clinical use in Europe under the Safilens brand, where the underlying EDOF platform has demonstrated high fitting success and rapid patient acceptance, underscoring its readiness for U.S. clinical practice.

Manufactured from vifilcon C hydrogel and enhanced with natural co-polymers, hyaluronic acid, and tamarind seed polysaccharide, Deseyne is designed to support sustained hydration, comfort, and visual stability throughout the day. As a daily disposable soft contact lens, it offers a safety profile associated with a lower risk of lens-related adverse events, with no adverse events reported in the clinical study.

Presbyopia is an age-related vision condition in which the eye gradually loses its ability to focus on nearby objects, such as when reading or doing close-up tasks. This occurs because the lens inside the eye becomes less flexible over time, making it harder to shift focus between distant and near objects. Presbyopia affects nearly all adults older than 45, underscoring the broad clinical and societal impact of innovations that expand non-surgical treatment options. Globally, an estimated 1.8 billion people are affected, and market research estimates the presbyopia market at more than $17 billion, with continued growth expected as populations age, screen use increases, and demand rises for effective, non-surgical vision correction solutions.

“Salution Nexus is honored to support the U.S. introduction of Deseyne,” Salution Nexus President/CEO Malvina Eydelman, M.D., commented. “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.”

Co-founded by Catalfamo and Bruno, Cataltheia Group is a medical innovation ecosystem focused on advancing biomimetic technologies inspired by natural biological systems. At the core of Cataltheia’s mission is identifying and advancing disruptive biotechnologies and removing the barriers that stand between these breakthroughs and the patients who need them most. The organization develops interdisciplinary solutions integrating biology, materials science, and artificial intelligence to deliver clinically meaningful outcomes.

Co-founded in 2019 by the Bruno family—owners of one of Italy’s largest pharmaceutical companies and a developer of pharmaceutical innovation—Bruno Vision Care LLC advances vision health through clinically validated, non-surgical innovations. The company focuses on improving quality of life by developing technologies that address unmet needs in vision care, including presbyopia.