SightGlass Vision has been granted Breakthrough Device designation for its Diffusion Optics Technology (DOT) spectacle lenses from the United States Food and Drug Administration (FDA).
Developed via a joint venture between CooperCompanies and EssilorAustralia, DOT spectacle lenses are intended to slow myopia progression in children. The unique design uses a contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina.
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 FDA feedback during the premarket review phase and a prioritised submission review. Since the program’s introduction in 2015, only 18 other ophthalmic devices have received the Breakthrough Device designation (Figures 1 and 2).1
Figure 1. As of June 30, 2023. FDA Breakthrough Devices Program.1
Figure 2. Number of Granted Breakthrough Device Designations by Clinical Panel.1
“The FDA Breakthrough Device designation for Diffusion Optics Technology (DOT) spectacle lenses is a milestone for our organisation – and for the broader fight against the paediatric myopia epidemic. Recent studies2,3 illustrate that about half of United States 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 US market clearance.”
SightGlass Vision’s patent-protected technology has demonstrated proven efficacy and safety through rigorous clinical evaluation.4,5,6,7 Full fouryear outcomes from the pivotal CYPRESS study, reported in September 2023, showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.8
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. They are not currently available for sale in Australia or the United States.
References
- Food and Drug Administration, Breakthrough Devices Program (webpage), available at: fda.gov/medical-devices/ how-study-and-market-your-device/breakthrough-devicesprogram#metrics [accessed Feb 2024].
- 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.
- Jobson Optical Research, Myopia Management 2024, January 2024. Available at: reviewofmm.com/2024-myopiareport [accessed Feb 2024].
- Rappon, J., Chung, C., Young, G., et al., Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). Br J Ophthalmol. 2023 Nov;107(11):1709–1715. DOI: 10.1136/bjo-2021-321005.
- Rappon, J., et al. Two-year effectiveness of a novel myopia management spectacle lens with fulltime wearers. Invest. Ophthalmol. Vis. Sci. 2022;63(7):408.
- 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.
- 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.
- Zhu, X., Laughton, D. Hill, J.S., et al., Control of myopia using diffusion optics technology spectacle lenses: efficacy and safety study (CYPRESS) 4 year results. Presented at CCOS 2023.
