Feb. 15, 2024 — SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica to address the myopia epidemic, has received a Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Diffusion Optics Technology (DOT) spectacle lenses engineered to slow myopia progression in children. According to the company, “the design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina.”

DOT spectacle lenses have debuted in several markets including China, the Netherlands, and Israel, as well as through preliminary market trials in other countries. As reported last September, full four-year outcomes from the Cypress study showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.

The FDA’s Breakthrough Devices Program recognizes innovative devices that display “effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions,” SightGlass Vision shares. The program has recognized 18 ophthalmic devices since its inception in 2015.

CEO of SightGlass Vision acknowledges the designation as a milestone for both the company and overall efforts to combat the pediatric myopia epidemic.