SightGlass Vision Achieves CE Mark Allowing European Marketing Authorization for Novel Eyeglasses That Slow Myopia Progression in Children
First-in-class, advanced diffusion optics technology spectacle lenses hailed as revolutionary innovation in myopia management
Jun 03, 2020, 07:45 ET
PALO ALTO, Calif., June 3, 2020 /PRNewswire/ -- SightGlass Vision, Inc., 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.
About Myopia
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.
Myopia has seen a dramatic increase in prevalence over the past several decades. In the early 1970's, only 25 percent of Americans were nearsighted. By the early 2000's, that number had jumped to more than 40 percent. Today, the number of nearsighted people is at epidemic proportions globally. Myopia is the leading cause of irreversible blindness in parts of Asia. Most alarming is approximately half of all young adults in the U.S. and Europe are nearsighted – double the number from when their grandparents were the same age. And in China, about 80 to 90 percent of teens and young adults are myopic, up from 10 to 20 percent just 65 years ago. It is estimated that almost half of the entire world's population, or five billion people, will be nearsighted by 2050. This increase is thought to relate to lifestyle changes, including less time outdoors and more eye-straining or near work-related activities such as reading and screen time. Early intervention is key to preventing high myopia from developing.
About SightGlass Vision, Inc.
SightGlass Vision, Inc. is a life sciences company focused on ending nearsightedness (myopia). Headquartered in Palo Alto, CA, SightGlass is developing innovative spectacle lenses to reduce the progression of myopia in children. Based on groundbreaking research from the University of Washington, SightGlass was founded in 2016 by Professors Jay and Maureen Neitz, and Dr. James Kuchenbecker, who are world-renowned vision researchers, and Dr. Thomas Chalberg, a serial entrepreneur in the biotechnology and medical device sectors. For more information, please visit www.sightglassvision.com.
SOURCE SightGlass Vision, Inc.
