Connect with us

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




(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 studies1,2 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

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




The Best Overall Progressive Lens, Now Powered by AI

Engineered with Behavioral Artificial Intelligence and utilizing new XR-motion™ technology, Varilux XR series goes beyond prescription and eye physiology to consider the patient’s visual behavior and design a progressive lens that respects how
their eyes naturally move.

Varilux XR series comes in two versions, Varilux® XR design and Varilux® XR track. The Varilux XR track lens provides an additional level of personalization by incorporating the exclusive Near Vision Behavior Measurement, providing up to 25% more near vision width3 according to the patient’s need, so patients get the highest level of customization.

Discover Varilux XR series and enjoy instantly sharp vision in motion4 and seamless transitions from near to far.

For more information, visit here.

Promoted Headlines






Get the most important news and business ideas for eyecare professionals every weekday from INVISION.


Most Popular