SightGlass Vision has been granted a ‘Breakthrough Device’ designation by the US Food and Drug Administration for its Diffusion Optics Technology (DOT) spectacle lenses designed to slow myopia progression in children.

Marking a milestone for the Company and the broader fight against the pediatric myopia epidemic, the ‘Breakthrough Devices’ designation granted to SightGlass Vision EssilorLuxottica’s myopia management joint venture with CooperCompanies – is limited to a small number of highly innovative devices that address irreversible debilitating disease. In fact, only 18 other ophthalmic devices have received the designation since the start of the designation program in 2015.

With it, SightGlass Vision will benefit from more frequent opportunities for FDA feedback during the premarket review phase for DOT lenses as well as prioritized submission review. EssilorLuxottica and SightGlass Vision will continue to collaborate closely with the FDA, supporting their goal to improve access to vision care and expand the myopia management category.

DOT: Reinforcing Leadership in Myopia

The unique design of SightGlass Vision’s DOT is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina.

Helping reinforce its leadership in myopia, this patent-protected technology has demonstrated proven efficacy and safety through rigorous clinical evaluation. Full four-year outcomes reported in September 2023 from the pivotal CYPRESS study showed statistically significant slowing of the eye axial length progression and cycloplegic spherical equivalent refraction.

DOT spectacle lenses are available in several markets, including China, the Netherlands and Israel, as well as through preliminary market trials in other countries.