FDA approves presbyopia contact lens with prolonged depth of focus
December 30, 2025
2 min learn
Key takeaways:
- The lens has prolonged depth of focus reasonably than a multifocal design for presbyopia.
- A hyper-refractive central zone permits for steady focus in close to, intermediate and distance imaginative and prescient.
The FDA has authorized Deseyne contact lenses with prolonged depth of focus for the correction of presbyopia, based on a press launch from Bruno Imaginative and prescient Care.
It’s the first day by day disposable mushy contact lens within the U.S. that includes prolonged depth of focus (EDOF), reasonably than a multifocal design, to appropriate presbyopia, based on the discharge. It permits for “steady focus from close to to far, with no affected person cognitive adaptation interval required,” Eddie Catalfamo, cofounder and CEO of Cataltheia Group, of which Bruno Imaginative and prescient Care is a subsidiary, instructed Healio.
The FDA has authorized Deseyne contact lenses with prolonged depth of focus for the correction of presbyopia.
The lens, fabricated from vifilcon C hydrogel materials, works utilizing a patented hyper-refractive central zone, reasonably than a number of zones as in multifocal designs, Bruno Imaginative and prescient Care said. It has been proven to extend depth of focus by about 0.78 D and close to and intermediate visible acuity by about 1.5 strains, Catalfamo stated.
The lens “is a one-of-a-kind recreation changer in presbyopia administration,” Mark Bullimore, FCOptom, PhD, FAAO, stated within the launch. In an announcement to Healio, he added that it might be simpler to adapt to than different lenses, with decrease dropout charges.
“EDOF intraocular lenses have confirmed fashionable with surgeons and sufferers alike, revolutionizing that portion of the trade since their introduction,” Bullimore instructed Healio. “The prolonged depth of focus lowers dependence on spectacle correction whereas exhibiting decrease charges of signs than multifocal applied sciences.”
The U.S. launch of this lens was supported by consulting from Salution Nexus, a part of the corporate Salution Well being, based on the discharge. In an announcement to Healio, cofounder Malvina Eydelman, MD, described Salution Well being as “the world’s first totally built-in human + AI-powered well being accelerator,” and Salution Nexus as its “international regulatory and scientific technique engine.”
“Salution Nexus offered singular regulatory and scientific experience to the workforce that led the Deseyne U.S. submission over an prolonged interval, supporting first-of-a-kind preclinical assessments and addressing distinctive regulatory points,” Eydelman stated. “This work helped form a strong proof and regulatory method aligned with FDA expectations, contributing to the product’s profitable entry to the U.S. market.”
In April, the FDA authorized day by day Deseyne contact lenses that includes FusionTechnology. The patented system depends on physique temperature, blinking and eyelid stress to ship a tear-like “pure copolymer” from the contact lens to the attention, based on a press launch.
Sources/Disclosures
Supply:
Press Launch
Reference:
Disclosures:
Catalfamo reviews being the cofounder and CEO of Cataltheia Group. Eydelman reviews being cofounder of Salution Well being and a advisor for Bruno Imaginative and prescient Care. Healio couldn’t affirm Bullimore’s related monetary disclosures on the time of publication.
Ask a scientific query and faucet into Healio AI’s data base.
- PubMed, enrolling/recruiting trials, pointers
- Scientific Steering, Healio CME, FDA information
- Healio’s unique day by day information protection of scientific information
