LOS ALTOS, Calif.—SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops technologies and science-based treatments to address the global myopia epidemic, 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, according to the company, 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, according to the company.

“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 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 clinical evaluation. As VMAIL 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.

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.