FDA Approves Breakthrough EDOF Contact Lens for Presbyopia

​The U.S. Food and Drug Administration (FDA) has officially cleared Deseyne contact lenses, developed by Bruno Vision Care, for the correction of presbyopia. This marks a significant shift in non-surgical vision correction by introducing Extended Depth of Focus (EDOF) technology to daily disposable soft lenses.

The Deseyne® lenses are a breakthrough in contact lens technology, integrating two patented innovations: the material of the lens (vifilcon C--a unique enriched hydrogel material) and the FusionTechnology™ delivery system. During the manufacturing process, bioactive substances known as Lachryceuticals®, which include amino acids, vitamins, and polysaccharides, are embedded within the lens matrix. Thanks to the patented controlled release mechanism, these substances are gradually delivered from the contact lens to the anterior segment of the eye, guaranteeing the bioavailability of these substances during the wearing period for natural, long-lasting comfort.

FusionTechnology™ merges hyaluronic acid (HA) with Tamarind Seed Polysaccharides (TSP®) to create a natural bio-copolymer that resembles tears. This substance is released steadily, activated by body temperature, blinking, and eyelid pressure. These Lachryceuticals® blend seamlessly with the eye's natural tear film, improving hydration, comfort, and stability.

“Deseyne® isn’t just another contact lens, it defines a completely new category by incorporating a patented delivery system directly into the lens,” said Eddie Catalfamo, CEO of Bruno Vision Care. “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.”

Bruno Vision Care brings the experience of a proven management team and a seasoned medical advisory board to launch the Deseyne® lenses to the U.S. market. The company expects the Deseyne® lenses to be available to consumers in the fourth quarter of 2025.

Paul Karpecki, O.D., a leader in the field of dry eye disease for over twenty-five years, stated, “There is nothing like the Deseyne® lens with FusionTechnology™ on the market today. The unique design releases Lachryceuticals®-key components of the tear film-in a controlled, continuous manner throughout the day, maintaining eye hydration and comfort that no other lens can achieve. Dryness is the leading cause of performance issues in contact lens wearers and the primary reason over 18% of these patients drop out each year. This lens promotes ocular health and provides a level of comfort unmatched by anything else in the industry.”

Catalfamo continued, “U.S. FDA approval is a major milestone for Bruno Vision Care as we set out to bring radical innovation to the multi-billion-dollar global soft contact lens market, which has seen little innovation in recent years. We see a significant opportunity to gain market share by delivering truly groundbreaking products that meet consumer needs. With powerful structural tailwinds-including an aging population, rising disposable income, advancements in technology, and an increasing incidence of distance vision impairment—we believe our Deseyne® lens is just the beginning of our efforts to redefine vision health and bring meaningful improvements to consumers worldwide.”

Catalfamo concluded, “Bringing this breakthrough to the U.S. market has been our mission for many years, and we could not have achieved this without the hard work and determination of our U.S. and Italian teams. We are immensely grateful to Vincenzo Bruno and his family, our General Manager, Daniele Bazzocchi, for his drive and technical expertise, and to the exceptional world-class leaders who guided us throughout the FDA clearance process to launch a product that sets a new standard for patient care and transforms the future of eye health.”