The US Food and Drug Administration (FDA) 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 design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina., though it is not yet available for sale in the United States.
The FDA’s Breakthrough Devices Programme is for “highly innovative devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions,” stated SightGlass Vision. Manufacturers are given more frequent opportunities for FDA feedback during the pre-market review phase, as well as a prioritised submission review.
Since the programme’s introduction in 2015, and as of 30 June 2023, only 18 other ophthalmic devices have received the Breakthrough Device designation.
“The FDA Breakthrough Device designation for Diffusion Optics Technology spectacle lenses is a milestone for our organisation – and for the broader fight against the paediatric myopia epidemic,” said Andrew Sedgwick, CEO of SightGlass Vision.
“Recent studies 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 is a joint venture of CooperCompanies and EssilorLuxottica.