FDA Grants Breakthrough Device Designation to SightGlass Vision's DOT Spectacle Lenses

SightGlass Vision, a pioneering joint venture between CooperCompanies and EssilorLuxottica focusing on combating the global myopia epidemic, has received a significant boost in its mission. The company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its groundbreaking Diffusion Optics Technology (DOT) spectacle lenses. These lenses are designed to slow the progression of myopia in children, marking a significant advancement in the field of pediatric eye care.

The DOT spectacle lenses utilise a unique design that employs a contrast management mechanism of action, dispersing light gently across the retina through thousands of elements. This innovative approach has garnered the attention of the FDA, leading to the prestigious Breakthrough Device designation. This program is reserved for highly innovative devices that offer more effective treatments or diagnosis for life-threatening or debilitating conditions. It provides manufacturers with enhanced opportunities for FDA feedback during the premarket review phase and prioritized submission review.

Andrew Sedgwick, CEO of SightGlass Vision, expressed his enthusiasm regarding the FDA's decision, stating, "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." Sedgwick highlighted recent studies indicating that approximately half of U.S. children are affected by myopia, yet many do not receive treatments proven to slow its progression. He emphasized the company's commitment to collaborating closely with the FDA as they pursue U.S. market clearance for the innovative lenses.

SightGlass Vision's patented technology has undergone rigorous clinical evaluation, demonstrating both efficacy and safety. The pivotal CYPRESS study, completed in September 2023, revealed statistically significant results, showing a slowdown in axial length progression and cycloplegic spherical equivalent refraction over four years.

While SightGlass Vision's DOT spectacle lenses have already made a commercial debut in several international markets, including China, the Netherlands, and Israel, they are also undergoing preliminary market trials in other countries.