FDA clears first daily disposable EDOF contact lens for presbyopia

The US FDA has officially cleared the first and only daily disposable soft (hydrophilic) contact lens for presbyopia that utilizes patented Extended Depth of Focus (EDOF) optical design technology.¹ The Cataltheia Group and its US subsidiary Bruno Vision Care stated in a news release that the Deseyne® lens “delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise.”

Cataltheia’s patented hyper-refractive central zone aids in this “smoothness,” as it works to precisely redirect light in a controlled fashion. The FDA’s decision adds to more than a decade of real-world clinical use of the lens in Europe under the Safilens brand. High fitting success and rapid patient acceptance have been recorded over the past decade.¹

“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, cofounder and CEO of Cataltheia Group, in the release. “With Deseyne, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses.”

Formerly, the EDOF technology was specifically limited to intraocular lenses. The Deseyne lens brings the technology outside of the surgical sphere and delivers “a depth of focus comparable to FDA-approved EDOF intraocular lenses, with clinically meaningful improvements in near and intermediate vision,” the release stated.¹ Visual acuity improved to 20/20 and 20/31 at intermediate and near distances, respectively.² There were no adverse events reported in the clinical study that supported the FDA decision.^1,2

EDOF technology in the lens works with a small, on-axis hyper-refractive zone, which prevents axial and paraxial light from contributing to retinal image formation, which then dictates how clarity is formed.¹

Additionally, eye care providers provided comments as to how the Deseyne lenses provide a proven alternative to multifocal lenses for patients with presbyopia.

“The Deseyne lens represents a clear clinical advantage over multifocal designs,” said Paul Karpecki, OD, FAAO, in the release. “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.

The lens is manufactured from vifilcon C hydrogel and consists of natural co-polymers, hyaluronic acid, and tamarind seed polysaccharide, all of which support sustained hydration, comfort, and visual stability throughout a day of wear.¹

“Salution Nexus is honored to support the U.S. introduction of Deseyne®,” said Malvina Eydelman, MD, president and CEO of Salution Nexus, in the release. “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.”

Prior FDA decisions

Previously, the Deseyne daily disposable contact lens with FusionTechnology™ was cleared by the FDA in April 2025. The technology merges hyaluronic acid and tamarind seed polysaccharides to create a natural bio-copolymer, which resembles natural tears and is released based on factors such as body temperature, blinking, and eyelid pressure. The Lachryceuticals, including the amino acids, vitamins, and polysaccharides, are also integrated into the eye’s natural tear film, according to a news release.³

“Deseyne isn’t just another contact lens, it defines a completely new category by incorporating a patented delivery system directly into the lens,” said Catalfamo in the release.³ “With our patented FusionTechnology proprietary manufacturing process and the novel vifilcon C material, we’re setting a new standard in vision health. The result is a lens that allows more people to wear contacts comfortably, provides existing wearers with greater hydration and clearer vision, and makes fitting easier for eye care professionals. It’s a true breakthrough for the industry and a game-changer for consumers.”

Both the vifilcon C and FusionTechnology were cleared by the FDA in October 2024.²

References:

1. FDA clears first extended Depth of Focus contact lens for presbyopia. News release. Businesswire. December 23, 2025. Accessed January 12, 2026. https://www.businesswire.com/news/home/20251222625759/en/FDA-Clears-First-Extended-Depth-of-Focus-Contact-Lens-for-Presbyopia

2. Deseyne. Bruno Vision Care. Accessed January 12, 2026. https://www.brunovisioncare.com/edof

3. Bruno Vision Care receives FDA approval for Deseyne contact lens with FusionTechnology. News release. Businesswire. April 14, 2025. Accessed January 12, 2026. https://www.businesswire.com/news/home/20250414396492/en/Bruno-Vision-Care-Receives-FDA-Approval-for-Deseyne-Contact-Lens-with-FusionTechnology