FDA grants SightGlass Vision Breakthrough Device designation for DOT spectacle lenses

(Image credit: Adobe Stock / ©Irina Schmidt)

The FDA has granted Breakthrough Device designation for SightGlass Vision's Diffusion Optics Technology (DOT) spectacles lenses, which are under investigation for the slowing of myopia in children.¹ DOT is the first design to leverage contrast management mechanism of action, which gently scatters light across the retina. If approved by the FDA, DOT spectacle lenses will be the first non-contact lens myopia control tactic available to the US market.

“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 studies^2,3 illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” Andrew Sedgwick, CEO of SightGlass Vision, said in a press release. “We are enthusiastic about more closely collaborating with the FDA as we pursue US market clearance.”

DOT technology has a rich history of positive results in clinical trials. The CYPRESS study is in its 5th year, with the most recent data presented in September 2023 at the Congress of the Chinese Ophthalmological Society in Changsha.⁴ The full 4-year outcomes showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction (cSER) in patients aged 6-10 who used DOT spectacle lenses.

Prior to this, SightGlass Vision presented positive outcomes at ARVO 2023 in New Orleans, Louisiana. The 42-month data from the CYPRESS study extension indicated positive safety and efficacy in children aged 6-10 (at the start of the study).⁵ The extension re-enrolled 98 patients from the original multi-site clinical trial, which had previously reported improvements in axial length and cSER.

SightGlass Vision, which is a joint venture of CooperCompanies and EssilorLuxottica, has set its sights on developing innovative technologies to combat the global myopia crisis. DOT spectacle lenses are already on the market in China, the Netherlands, and Israel, and the technology is in preliminary market trials in other countries.

References

1. SightGlass Vision receives breakthrough device designation from US Food and Drug Administration. Press release. February 14, 2024. Accessed February 15, 2024.

2. 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.

3. Myopia Management 2024 Report, Jobson Optical Research, January 2024. https://reviewofmm.com/2024-myopia-report/

4. SightGlass presents four-year results of CYPRESS trial at CCOS. Review of Myopia Management. September 5, 2023. Accessed February 15, 2024. https://reviewofmm.com/sightglass-presents-four-year-results-of-cypress-trial-at-ccos/

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.