SightGlass Vision receives Breakthrough Device Designation from FDA for DOT spectacle lenses
SightGlass Vision, a joint venture of CooperCompanies and EssilorLuxottica that develops technologies and science-based treatments to address the global myopia epidemic, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its Diffusion Optics Technology (DOT) spectacle lenses, which are intended to slow myopia progression in children. The unique design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina.
FDA Breakthrough Devices Program
The FDA’s Breakthrough Devices Program is for highly innovative devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Manufacturers are given more frequent opportunities for FDA feedback during the premarket review phase, as well as a prioritized submission review. Since the program’s introduction in 2015, only 18 other ophthalmic devices have received the Breakthrough Device designation.*
“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. Recent studies1,2 illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” said Andrew Sedgwick, CEO of SightGlass Vision. “We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance.”
Technology has demonstrated proven efficacy
SightGlass Vision’s patent-protected technology has demonstrated proven efficacy and safety through rigorous clinical evaluation.3,4,5,6 As reported in September 2023, full four-year outcomes from the pivotal CYPRESS study showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.7
Diffusion Optics Technology™ (DOT™) spectacle lenses have made their commercial debut in several markets, including China, the Netherlands, and Israel, as well as through preliminary market trials in other countries. For more information, visit SightGlassVision.com.
SightGlass Vision™ Diffusion Optics Technology™ (DOT™) spectacle lenses are not available for sale in the United States.
* As of June 30, 2023. FDA Breakthrough Devices Program. Graph 2: Number of Granted Breakthrough Device Designations by Clinical Panel. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#metrics
1 Kwan J, et al. Current Trends in Pediatric Eye Examinations and Contact Lens Prescribing in the U.S. Poster presentation at the Global Specialty Lens Symposium, January 2024.
2 Myopia Management 2024 Report, Jobson Optical Research, January 2024. https://reviewofmm.com/2024-myopia-report/
3 Control of myopia using Diffusion Optics Technology™ spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). British Journal of Ophthalmology Published Online First: 01 September 2022. DOI: 10.1136/bjo-2021-321005
4 Rappon J., et al. Two-year effectiveness of a novel myopia management spectacle lens with full-time WEARERS. Invest. Ophthalmol. Vis. Sci. 2022;63(7):408.
5 Chalberg T., et al. Control of Myopia Using Diffusion Optics Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 42-month results. ARVO 2023 Annual Meeting presentation. 27 April 2023.
6 Laughton, D et al. Safety and Efficacy of a Novel Spectacle Lens for Myopia Control Over Three Years. 2022 American Academy of Optometry annual meeting. 27 Oct 2022.
7 Xiaoying Zhu, Deborah Laughton, Jennifer S. Hill, Marcella McParland, Vanessa Tasso, Jay Neitz, Maureen Neitz, Thomas W. Chalberg. Control of Myopia using Diffusion Optics Technology Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 4 Year Results. Presented at CCOS 2023.
