SightGlass Vision announced it has achieved CE Mark approval for its first product – novel eyeglasses designed to slow the progression of myopia in children. The approval allows the SightGlass Vision to commercialize its suite of Diffusion Optics Technology (DOT) products across the EU, United Kingdom, and other European Economic Area countries.
The CE Mark declaration allowing European Marketing Authorization includes products containing anti-reflective and photochromic technologies, making the company’s DOT lenses the first product that has shown success in a multicenter, randomized, controlled clinical trial to include these options for myopia management.
“Our novel spectacle lenses designed to slow myopia progression in children have been hailed as a revolutionary innovation in the field of myopia management. The CE Mark allowing European Marketing Authorization for our suite of DOT products is an important leap forward for our company, as we advance our mission to end myopia,” Thomas W. Chalberg, PhD, Founder and Chief Executive Officer, said in a company news release. “We look forward to bringing to market a powerful and unique mechanism of action that we are confident will benefit children in the EU and other CE Mark geographies who live with myopia and are at risk from its vision-threatening complications.”
SightGlass Vision also received ISO 13485:2016 certification of its manufacturing process, facility, and quality management system in 2019. This certification demonstrates the company’s focus on quality and its ability to provide a portfolio of DOT spectacle lenses that consistently meet both customer and applicable regulatory requirements. In addition, SightGlass Vision’s quality systems meet the new EU rules for medical device manufacturers, known as Medical Devices Regulation, which is scheduled to take effect on May 26, 2021.