The Food and Drug Administration (FDA) in the US has granted Breakthrough Device designation to SightGlass Vision’s diffusion optics technology (DOT) spectacle lenses, which are intended to slow myopia progression in children.
The lenses are a joint venture between CooperVision and EssilorLuxottica and, if approved by the FDA, will be among a handful of treatments with a myopia control indication in the US market.
In 2019, CooperVision’s MiSight 1 day lens became the first and only FDA-approved product to slow the progression of myopia in children. The soft contact lens was approved for children aged eight to 12.
The design of DOT spectacle lenses is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina, according to SightGlass.
The FDA’s breakthrough devices program is for 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 prioritised submission review.
“The FDA Breakthrough Device designation for DOT spectacle lenses is a milestone for our organisation – and for the broader fight against the paediatric myopia epidemic,” Mr Andrew Sedgwick, CEO of SightGlass Vision, said.
“Recent studies1,2 illustrate that about half of US children are myopic, yet most are not receiving treatments proven to slow myopia progression. We are enthusiastic about more closely collaborating with the FDA as we pursue US market clearance.”
SightGlass Vision’s patent-protected technology has demonstrated efficacy and safety through rigorous clinical evaluation.3-6 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
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.
More reading
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References
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.
