Press Releases

SightGlass Vision Receives Breakthrough Device Designation From U.S. Food and Drug Administration

Decision is the latest milestone for diffusion optics technology (DOT) Spectacle lenses designed to slow myopia progression in children

Published

7 months ago

February 15, 2024

Press Releases

(PRESS RELEASE) LOS ALTOS, CA — SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops innovative technologies and science-based treatments to address the global myopia epidemic, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its Diffusion Optics Technology(DOT) spectacle lenses, which are intended to slow myopia progression in children. The unique design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina.

The FDA’s Breakthrough Devices Program is for highly innovative devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Manufacturers are given more frequent opportunities for FDA feedback during the premarket review phase, as well as a prioritized submission review. Since the program’s introduction in 2015, only 18 other ophthalmic devices have received the Breakthrough Device designation.^*

“The FDA Breakthrough Device designation for Diffusion Optics Technology (DOT) spectacle lenses is a milestone for our organization—and for the broader fight against the pediatric myopia epidemic. Recent studies^1,2 illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” said Andrew Sedgwick, CEO of SightGlass Vision. “We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance.”

SightGlass Vision’s patent-protected technology has demonstrated proven efficacy and safety through rigorous clinical evaluation.^3,4,5,6 As reported in September 2023, full four-year outcomes from the pivotal CYPRESS study showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.⁷

Diffusion Optics Technology (DOT) spectacle lenses have made their commercial debut in several markets, including China, the Netherlands, and Israel, as well as through preliminary market trials in other countries. For more information, visit SightGlassVision.com.

SightGlass Vision Diffusion Optics Technology (DOT) spectacle lenses are not available for sale in the United States.

click to Comment(Comment)

Up Next

XP Health Continues Momentum With New Bell Bank Partnership and Addition of a CMO to Its Leadership Roster

Don't Miss

EssilorLuxottica Board of Directors Proposes Nominees to the New Board

With Crizal you can have it all!

Patients expect clarity of vision, scratch resistance, anti-glare technology, easy-to-clean lenses, and UV protection from their lenses. Crizal Sapphire HR is the latest generation of anti-reflective coating that combines our innovative technologies, 360 Multi-angular Technology™, High-Resistance Technology™, High Surface Density Process™ into one coating to deliver best in class performance. Your patients’ main concerns of anti-glare, scratch resistance, and easiness to clean are covered. Crizal Sapphire HR shield the lenses against reflections, scratching, smudging and UV light for long-lasting transparency, durability, and protection. Crizal coatings can be applied to any design, including traditional single vision, Eyezen®, Eyezen+ and Varilux®! Widely available across lab networks and through all major managed vision care providers today. Crizal Saphire HR benefits include: • 360 Multi-angular Technology™ that cuts front and lateral backside reflection • High-Resistance Technology™ that offers the best combination of scratch and smudge resistance • High Surface Density Process™ that ensures the lense is easy-to-clean, smudge resistant and water repellent For more information about Crizal Saphire HR, go here.