The CE Mark confirms that SightGlass Vision's Diffusion Optics Technology (DOT) spectacle lens products meet European Union (EU) regulatory standards, and allows the Company to commercialize its suite of DOT products across the EU, United Kingdom, and other European Economic Area countries
SightGlass Vision, a life sciences company focused on ending nearsightedness (myopia), today announced it has achieved Conformité Européene (CE) Mark declaration on its first product – the Company’s novel eyeglasses designed to slow the progression of myopia in children. The CE Mark confirms that SightGlass Vision’s Diffusion Optics Technology (DOT) spectacle lens products meet European Union (EU) regulatory standards, and allows the Company to commercialize its suite of 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 multi-center, 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. 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,” said Thomas W. Chalberg, Ph.D., Founder and Chief Executive Officer.
The CE Mark is a certification mark in Europe that signals conformity to patient and user safety and device performance standards in the region. It is considered an essential regulatory requirement for companies intending to sell medical products in the European Economic Area.
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.
Nearsightedness or myopia is a condition that occurs when the light coming into an eye does not focus on the retina, but in front of it, making things look blurry. For most people, myopia is usually a minor inconvenience and is correctable. However, myopia increases the risk of serious eye conditions such as myopic maculopathy, retinal detachment, and glaucoma, making it one of the leading causes of visual impairment and blindness.
Source: Company Press Release