FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia Treatment
核心洞察
The FDA has cleared Deseyne (搜索)®, the first daily disposable contact lens utilizing Extended Depth of Focus (EDOF) technology for presbyopia (搜索) treatment in the United States.
The lens delivers continuous focus across near, intermediate, and distance vision through a patented hyper-refractive central zone (搜索) design, offering advantages over traditional multifocal lenses.
Presbyopia (搜索) affects an estimated 1.8 billion people worldwide, representing a market valued at more than $17 billion with continued growth expected.
The U.S. Food and Drug Administration has cleared the first daily disposable soft contact lens for presbyopia (搜索) utilizing Extended Depth of Focus (EDOF) optical design technology, marking a significant advancement in non-surgical vision correction. The Cataltheia Group (搜索) and its U.S. subsidiary Bruno Vision Care LLC (搜索) announced the clearance of Deseyne (搜索)®, enabling commercial distribution across the United States.
Revolutionary EDOF Technology in Contact Lens Format
Deseyne (搜索)® delivers smooth, continuous focus across near, intermediate, and distance vision through Cataltheia's patented hyper-refractive central zone (搜索), which precisely redirects light in a controlled manner. This represents the first time EDOF technology, previously limited to intraocular lenses requiring permanent surgical implantation, has been made available in a non-surgical contact lens 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 (搜索). "With Deseyne (搜索)®, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses."
Clinical Advantages Over Existing Options
The lens provides a clear clinical advantage over multifocal lenses, which rely on multiple optical zones and often require prolonged visual and cognitive adaptation. Paul Karpecki, OD, FAAO, director of Cornea and External Disease for the Kentucky Eye Institute, explained that "The Deseyne (搜索)® lens represents a clear clinical advantage over multifocal designs. Its single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency."
Deseyne (搜索)® delivers a depth of focus comparable to FDA-approved EDOF intraocular lenses, with clinically meaningful improvements in near and intermediate vision. Mark Bullimore, FCOptom, PhD, FAAO, described the lens as "a one-of-a-kind game changer in presbyopia (搜索) management."
Material Composition and Safety Profile
Manufactured from vifilcon C hydrogel and enhanced with natural co-polymers, hyaluronic acid, and tamarind seed polysaccharide, Deseyne (搜索)® 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.
Market Impact and Clinical Foundation
The FDA clearance addresses a significant unmet medical need, as presbyopia (搜索) affects nearly all adults over age 45 and an estimated 1.8 billion people worldwide. 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.
The approval 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. In April 2024, Bruno Vision Care LLC (搜索) received FDA approval for the base lens material and technology components of Deseyne (搜索)®.
"This milestone reflects how rigorous regulatory strategy can translate into real-world innovation—delivering meaningful advances in presbyopia (搜索) care and expanding what people can see, do, and enjoy in everyday life," said Malvina Eydelman, MD, President and CEO of Salution Nexus, which supported the U.S. introduction.