HealthMatters
(PRESS RELEASE) LOS ALTOS, CA — SightGlass Imaginative and prescient, a three way partnership of CooperCompanies and EssilorLuxottica that develops revolutionary applied sciences and science-based therapies to deal with the worldwide myopia epidemic, in the present day introduced that the U.S. Meals and Drug Administration (FDA) has granted Breakthrough Gadget designation to its Diffusion Optics Expertise (DOT) spectacle lenses, that are supposed to gradual myopia development in kids. The distinctive design is the primary to make use of the distinction administration mechanism of motion, incorporating hundreds of components that lightly scatter mild throughout the retina.
The FDA’s Breakthrough Units Program is for extremely revolutionary units that present for simpler remedy or analysis of life-threatening or irreversibly debilitating human illness or circumstances. Producers are given extra frequent alternatives for FDA suggestions throughout the premarket assessment section, in addition to a prioritized submission assessment. Because the program’s introduction in 2015, solely 18 different ophthalmic units have obtained the Breakthrough Gadget designation.*
“The FDA Breakthrough Gadget designation for Diffusion Optics Expertise (DOT) spectacle lenses is a milestone for our group—and for the broader battle in opposition to the pediatric myopia epidemic. Current research1,2 illustrate that about half of U.S. kids are myopic, but most aren’t receiving therapies confirmed to gradual myopia development,” mentioned Andrew Sedgwick, CEO of SightGlass Imaginative and prescient. “We’re obsessed with extra intently collaborating with the FDA as we pursue U.S. market clearance.”
SightGlass Imaginative and prescient’s patent-protected know-how has demonstrated confirmed efficacy and security by means of rigorous medical analysis.3,4,5,6 As reported in September 2023, full four-year outcomes from the pivotal CYPRESS examine confirmed statistically vital slowing of axial size development and cycloplegic spherical equal refraction.7
Diffusion Optics Expertise (DOT) spectacle lenses have made their industrial debut in a number of markets, together with China, the Netherlands, and Israel, in addition to by means of preliminary market trials in different nations. For extra data, go to SightGlassVision.com.
SightGlass Imaginative and prescient Diffusion Optics Expertise (DOT) spectacle lenses aren’t accessible on the market in the USA.
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