SightGlass receives FDA breakthrough designation for spectacle lenses that slow myopia
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The FDA has granted breakthrough device designation to SightGlass Vision’s diffusion optics technology spectacle lenses, which are designed to slow myopia progression in children.
“Recent studies illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” Andrew Sedgwick, SightGlass Vision’s CEO, said in a company press release. “We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance.”
According to the release, the company’s diffusion optics technology (DOT) features thousands of light-scattering elements that mimic natural contrast on the retina and reduce myopic progression, proven safe and effective in clinical evaluation.
The FDA’s breakthrough devices program offers manufacturers more frequent opportunities to receive feedback on innovative devices that can effectively treat or diagnose debilitating diseases like myopia. Only 18 ophthalmic devices have received this designation since the program’s conception in 2015, the release stated.
“The FDA breakthrough device designation for DOT spectacle lenses is a milestone for our organization — and for the broader fight against the pediatric myopia epidemic,” Sedgwick said in the release.
Perspective
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Sherman Tung, OD, FAAO, FIAOMC, IACMM
I have observed the positive impact of anti-myopia spectacles in my clinic and throughout Canada. Diverse myopia management tools offer flexibility, catering to individual patient needs. Educating parents about various myopia management options is crucial for informed decision-making regarding their children’s eye health. With a range of options, we tailor approaches to each child’s unique situation.
The DOT technology provides parents with flexibility, allowing them to choose over contact lenses and atropine, as these may not be feasible or accessible to some children. In my clinic over the past 2 years, working with DOT technology has shown great promise in stabilizing axial length, with no reported issues of adaptation. I anticipate that the next updated CYPRESS study in 3 years will provide valuable insights into sustained effectiveness.
Eye care practitioners should be excited about these technologies, as staying engaged enhances our myopia management strategies, ensuring we evolve to provide the best care for our patients’ eye health. It’s remarkable how much new technology and research have contributed to myopia management in the past half-decade.
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