{"id":62400,"date":"2025-12-23T19:05:57","date_gmt":"2025-12-23T18:05:57","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-clears-first-extended-depth-of-focus-contact-lens-for-presbyopia\/"},"modified":"2025-12-23T19:05:57","modified_gmt":"2025-12-23T18:05:57","slug":"fda-clears-first-extended-depth-of-focus-contact-lens-for-presbyopia","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-clears-first-extended-depth-of-focus-contact-lens-for-presbyopia\/","title":{"rendered":"FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia"},"content":{"rendered":"
\n

\nDeseyne\u00ae<\/sup> (vifilcon C) Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) Delivers Continuous Vision at All Distances\u2014Redefining Presbyopia Correction<\/b><\/p>\n

<\/a>
<\/a><\/p>\n

BOCA RATON, Fla.–(BUSINESS WIRE)–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.<\/p>\n

\nDeseyne\u00ae<\/sup> delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia\u2019s 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.<\/p>\n

\n\u201cWe are proud to offer the first contact lens solution for the world\u2019s aging population that delivers clear vision across all distances,\u201d said Eddie Catalfamo, Co-Founder and CEO of Cataltheia Group. \u201cWith Deseyne\u00ae<\/sup>, people can see clearly in the moments that matter without the tradeoffs associated with multifocal lenses.\u201d<\/p>\n

\n\u201cThe Deseyne\u00ae<\/sup> lens represents a clear clinical advantage over multifocal designs,\u201d said Paul Karpecki, OD, FAAO. \u201cIts single, spherical optical zone delivers continuous focus across distances, reducing the need for patient adaptation while improving fitting success and practice efficiency.\u201d<\/p>\n

\n\u201cThe Deseyne\u00ae<\/sup> lens is a one-of-a-kind game changer in presbyopia management,\u201d added Mark Bullimore, FCOptom, PhD, FAAO.<\/p>\n

\nUntil now, Extended Depth of Focus technology has been limited to intraocular lenses requiring permanent surgical implantation. Deseyne\u00ae<\/sup> 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\u2019s clearance marks a significant advance for the estimated 1.8 billion people worldwide living with presbyopia.<\/p>\n

\nThis milestone builds on more than a decade of real-world clinical use in Europe under the Safilens\u00ae<\/sup> brand, where the underlying EDOF platform has demonstrated high fitting success and rapid patient acceptance, underscoring its readiness for U.S. clinical practice.<\/p>\n

\nManufactured from vifilcon C hydrogel and enhanced with natural co-polymers, hyaluronic acid, and tamarind seed polysaccharide, Deseyne\u00ae<\/sup> 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.<\/p>\n

\nPresbyopia 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.<\/p>\n

\n\u201cSalution Nexus is honored to support the U.S. introduction of Deseyne\u00ae<\/sup>,\u201d said Malvina Eydelman, MD, President and CEO of Salution Nexus. \u201cThis milestone reflects how rigorous regulatory strategy can translate into real-world innovation\u2014delivering meaningful advances in presbyopia care and expanding what people can see, do, and enjoy in everyday life.\u201d<\/p>\n

\nCatalfamo concluded, \u201cWe thank Cataltheia\u2019s 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\u2019 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.\u201d<\/p>\n

\nAbout Cataltheia Group
\n
<\/b>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\u2019s 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.<\/p>\n

\nAbout Bruno Vision Care LLC
\n
<\/b>Co-founded in 2019 by the Bruno family, owners of one of Italy\u2019s 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.<\/p>\n

\nLearn more at www.brunovisioncare.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nPublicRelations@brunovisioncare.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Deseyne\u00ae (vifilcon C) Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) Delivers Continuous Vision at All Distances\u2014Redefining Presbyopia Correction BOCA RATON, Fla.–(BUSINESS WIRE)–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) … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62400","6":"format-standard","7":"category-industry"},"yoast_head":"\nFDA Clears First Extended Depth of Focus Contact Lens for Presbyopia - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/fda-clears-first-extended-depth-of-focus-contact-lens-for-presbyopia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Deseyne\u00ae (vifilcon C) Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia with Extended Depth of Focus (EDOF) Delivers Continuous Vision at All Distances\u2014Redefining Presbyopia Correction BOCA RATON, Fla.–(BUSINESS WIRE)–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) ... 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