SightGlass Vision, Inc., a joint venture between CooperCompanies and Essilor Luxottica, has received Breakthrough Device Designation (BDD) from the FDA for its Digital Optics Technology (DOT) spectacle lenses, designed to possibly slow the progression of pediatric myopia.
Let’s start with this designation.
The FDA’s BDD is intended to expedite the development and review process for new medical devices or drugs designed to treat or diagnose a serious or life-threatening disease.
In order to qualify, a medical device needs to have either breakthrough technology, no approved/cleared alternatives, significant advantages compared to any existing approved/cleared alternative devices, or have its availability be in the best interest for its target patients.
SightGlass noted that, since the Breakthrough Device Program launched in 2015, only 18 other ophthalmic devices have received this designation.
Now this DOT technology.
SightGlass Vision’s proprietary, patent-protected DOT is a lens technology focused on potentially slowing axial elongation resulting in the stabilization or reduction of myopia progression.
The technology’s acronym lends to its ability to integrate thousands of light-scattering elements—”dots”—that imitate more natural contrast at all distances before hitting the retina, according to the company.
…and these spectacle lenses?
Designed to be used with SightGlass Vision’s DOT, the spectacles are intended to potentially slow myopia progression in children (as young as 6 and up to age 13) by reducing contrast signaling within the retina via softly scattering thousands of micro-dots of light.
The SightGlass Vision DOT spectacles have been designed to moderate light:
- Before it hits the retina
- Before the retina detects artificial contrast and signals the eye to elongate
The resulting effect: clear central vision with slightly less contrast in the lens’s peripheral component.
What else makes this technology unique?
SightGlass has noted that its unique DOT design, “is the first to use the contrast mechanism of action” that involves thousands of elements to scatter light across the retina.
Notably, the technology and spectacle lenses are already commercially available in the Chinese, Dutch, and Israeli ophthalmic markets (plus preliminary market trials elsewhere in the world), according to the company.
What kind of clinical data is available on it?
Most recently in October 2023, SightGlass presented real-world efficacy data from the the Control of Myopia using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS) trial (NCT03623074), a 3-year study evaluating DOT lenses for pediatric myopia.
The findings: DOT lenses illustrated a decrease of myopia progression in clinical practice, suggesting results consistent with the previously-published positive CYPRESS extension trial (NCT04947735) clinical outcomes (see here and here for that 4-year extension study data).
Give me some numbers.
SightGlass has reported (based on 12-month results):
- 65% of pediatric participants had no clinical meaningful myopia progression after 1 year
- 59% reduced myopia progression was reported after 2 years of full-time wear
And more specifically?
The 4-year outcomes found a statistically significant slow down in axial length progression and in cycloplegic spherical equivalent refraction, according to the company.
Note, however, that the extension study isn’t slated to conclude until June 2025—meaning an additional data readout may be in the forecast down the road.
So what’s next?
As part of the FDA’s Breakthrough Devices program, SightGlass will likely receive an accelerated review process and prioritized evaluation for potentially faster market access.
“We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance,” stated CEO Andrew Sedgwick.