FDA Awards Breakthrough Device Status to SightGlass Vision’s Myopia Control Lenses

The FDA has recognized SightGlass Vision's Diffusion Optics Technology (DOT™) spectacle lenses with the Breakthrough Device designation. These lenses are designed to manage myopia progression in children by employing a unique contrast management mechanism. This mechanism involves integrating thousands of tiny elements within the lenses that distribute light gently across the retina, aiming to slow the progression of myopia in young patients.

The Breakthrough Devices Program by the FDA is intended to expedite the development and review process for medical devices that offer the potential for more effective treatment or diagnosis of serious or debilitating conditions. This designation allows for more frequent interactions with the FDA during the pre-market review phase and prioritizes the submission review process.

Andrew Sedgwick, CEO of SightGlass Vision, commented on the designation, 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." He noted the prevalence of myopia among U.S. children, with many not receiving effective treatments to manage the condition. Sedgwick expressed the company's eagerness to work closely with the FDA to achieve U.S. market clearance.

SightGlass Vision's technology has been validated for efficacy and safety through comprehensive clinical evaluations. The results from the pivotal CYPRESS study, published in September 2023, revealed that the technology could significantly slow down the progression of axial length and changes in cycloplegic spherical equivalent refraction over four years.

The DOT™ spectacle lenses have been launched commercially in several international markets, including China, the Netherlands, and Israel, with initial market trials conducted in other regions as well. This development, coupled with the FDA's Breakthrough Device designation, marks a step forward in addressing myopia progression in children on a global scale.