The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, today announced the publication of landmark clinical data in Optometry and Vision Science (OVS), the official journal of the American Academy of Optometry, validating the performance of the Deseyne® contact lens — the first and only FDA-cleared daily disposable soft contact lens for presbyopia featuring Extended Depth of Focus (EDOF) technology.
The peer-reviewed study demonstrated that the Deseyne® lens achieved a statistically significant increase in depth of focus compared with a monofocal control lens while providing meaningful increase in both near and intermediate visual acuity and maintaining distance vision performance.
The publication represents the first peer-reviewed clinical validation of the Deseyne® Daily Disposable soft contact lens for Presbyopia with Extended Depth of Focus (EDOF). Deseyne®’s novel EDOF technology marks a significant milestone for a platform that has already received industry recognition, including the 2026 MedTech Breakthrough Award for Best New Technology Solution in Ophthalmology.
“Bringing the first FDA-cleared daily disposable EDOF lens for presbyopia from concept to peer-reviewed publication is a milestone for our team and for the category,” said Eddie Catalfamo, Co-founder and Chief Executive Officer of The Cataltheia Group and co-author on the study. “Presbyopia is one of the largest unmet needs in vision care, and our goal with Deseyne® is to give eye care professionals a meaningful new option for their patients.”
Authored by Mark A. Bullimore, MCOptom, PhD, FAAO, et al, the randomized, crossover, non-dispensing clinical trial enrolled 78 presbyopic habitual soft contact lens wearers, ages 45 to 70, across three U.S. clinical sites.
A New Optical Architecture for a Growing Global Challenge
Presbyopia affects virtually every individual over the age of 45. The condition affects an estimated 139 million Americans and is projected to impact approximately 2.1 billion people worldwide by 2030. As the eye’s crystalline lens gradually loses flexibility with age, the ability to focus on near and intermediate objects declines, making presbyopia the leading cause of near-vision impairment globally.
The public health and economic consequences of vision impairment are substantial. Research has shown that uncorrected vision impairment is associated with increased risks of falls, depression, social isolation, and cognitive decline among older adults. The burden is substantial at the global level. The World Health Organization estimates that vision impairment, including uncorrected presbyopia, results in approximately $411 billion in lost global productivity each year.
Despite the growing size of the presbyopic population and continued advances in contact lens materials and comfort, most contact lens options available today rely on optical principles that have remained largely unchanged for decades. Traditional multifocal contact lenses use simultaneous-image optics, multiple optical powers, or power gradients designed to focus light from both near and distant objects onto the retina.
The Deseyne® contact lens introduces a radically different approach. Rather than relying on conventional multifocal optics, concentric zones, or simultaneous-image designs, the lens employs a novel Extended Depth of Focus architecture intended to expand the range over which objects remain in acceptable focus.
According to the published study, the lens features a spherical anterior optical surface across the 11-mm optic and a central 1.0-mm optically inactive zone. This central inactive zone allows light to pass through but is not intended to form a usable image for normal viewing distances; the surrounding central area, noted as steeper than the optical zone, is intended to increase depth of focus and improve near and intermediate vision. The authors reported that the Deseyne® lens demonstrated a statistically significant increase in depth of focus compared with a single vision control lens.
Landmark Clinical Results
The study confirmed that the Deseyne® lens achieved a statistically significant increase in depth of focus of +0.78 D compared with the monofocal control lens. Key findings included:
- Approximately 1.6 lines of improvement in near visual acuity
- Approximately 1.4 lines of improvement in intermediate visual acuity
- Distance visual acuity that remained statistically noninferior to the monofocal control lens
- No adverse events reported during the study
Notably, subjects aged 60 years and older experienced even greater benefits, achieving +0.88 D increase in depth of focus, approximately 2.0 lines of improvement in near visual acuity and 2.2 lines of improvement in intermediate visual acuity.
First Contact Lens Evaluated Against Established EDOF Standards
Because Deseyne® is the first and only FDA-cleared daily disposable soft contact lens for presbyopia featuring Extended Depth of Focus technology, no accepted EDOF contact lens performance criteria previously existed. As a result, investigators designed the study using the FDA-recognized ANSI Z80.35-2018 framework for Extended Depth of Focus intraocular lenses (IOLs), the established regulatory benchmark for evaluating EDOF performance.
Deseyne® was evaluated against the ANSI effectiveness requirements: increased depth of focus versus a monofocal control; median intermediate visual acuity at 66 cm of 0.2 logMAR or better; superior intermediate visual acuity compared with a monofocal control; and distance visual acuity statistically noninferior to a monofocal control.
In the study, Deseyne® exceeded the depth-of-focus criterion, demonstrating a mean extended depth of focus of +0.78 D compared with the monofocal control. The lens also met the intermediate vision criteria, with median monocular intermediate visual acuity of +0.02 logMAR and statistically superior intermediate visual acuity compared with the control. Deseyne® met the distance vision criterion as well, with monocular distance visual acuity remaining within the 0.1 logMAR noninferiority margin compared with the monofocal control.
Published in a Leading Peer-Reviewed Journal
The study was published in Optometry and Vision Science, the official journal of the American Academy of Optometry, under the editorial leadership of Editor-in-Chief David B. Elliott, PhD, FCOptom, FAAO. The publication provides the first peer-reviewed clinical validation of Deseyne contact lenses for presbyopia with Extended Depth of Focus technology (EDOF) and represents a new class of treatment in the evolution of contact lens-based presbyopia correction.
With FDA clearance, peer-reviewed clinical validation, and recognition as the 2026 MedTech Breakthrough Award winner for Best New Technology Solution in Ophthalmology, Deseyne® is positioned to establish a new category in presbyopia correction and address one of the largest and fastest-growing unmet needs in vision care worldwide.
“Many patients drop out of soft contact lens wear in their 40s and 50s because of presbyopia leading to poorer near vision. The availability of the first FDA approved extended depth of focus soft contact lens provides an exciting new option for practitioners,” said Mark Bullimore, MCOptom, PhD, FAAO. “This published paper provides the evidence base to help doctors make informed decisions when considering this lens for their patients, for example, what intermediate and near visual acuity can be expected?”
Availability
Interested eye care professionals can request a diagnostic kit ahead of the U.S. commercial launch of the Deseyne® Daily Disposable Extended Depth of Focus (EDOF) soft contact lens for presbyopia, expected by the end of Q4 2026, at www.brunovisioncare.com/for-professionals.
Learn more at www.brunovisioncare.com.
Source: Bullimore MA, et al. Optometry and Vision Science (2026). Epidemiologic and economic figures derived from the World Health Organization and the Lancet Global Health Commission on Global Eye Health.
About The Cataltheia Group
Co-founded by Eddie Catalfamo and Vincenzo Bruno, The Cataltheia Group is a medical innovation ecosystem focused on advancing biomimetic technologies inspired by natural biological systems. At the core of its 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
Established in 2019 as a subsidiary of Bruno Farmaceutici, Italy’s third-largest pharmaceutical company, Bruno Vision Care LLC translates a legacy of pharmaceutical innovation into vision care through clinically validated, non-surgical technologies that advance how vision care is delivered, including for presbyopia, with a focus on improving quality of life.
© Cataltheia Group and its affiliates 2026
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