FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia

The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States.

Deseyne^® delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia’s patented hyper-refractive central zone, engineered to precisely redirect light in a controlled manner. 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.

“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. “With Deseyne^®, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses.”

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

“The Deseyne^® lens is a one-of-a-kind game changer in presbyopia management,” added Mark Bullimore, FCOptom, PhD, FAAO.

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.

This 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 happens 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 over age 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^®,” said Malvina Eydelman, MD, President and CEO of Salution Nexus. “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.”

Catalfamo concluded, “We thank Cataltheia’s Co-Founder, Vincenzo Bruno, the incredible FDA team of expert scientists who rigorously evaluated our one-of-a-kind patented technology, our relentless and super skilled US team, the Safilens’ team, our Italian General Manager, Daniele Bazzocchi, and the world class leaders who guided our FDA clearance as we set a new standard in presbyopia care and patient health.”

About Cataltheia Group
Co-founded by Eddie Catalfamo and Vincenzo 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.

About Bruno Vision Care LLC
Co-founded in 2019 by the Bruno family, owners of one of Italy’s largest pharmaceutical companies and a longstanding leader in pharmaceutical innovation, Bruno Vision Care LLC is dedicated to advancing 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.

Learn more at www.brunovisioncare.com.

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