Luminopia, Inc. has released new real-world data (RWD) on its namesake binocular digital therapy platform for treating pediatric patients diagnosed with amblyopia (lazy eye).
First: How is this condition typically treated?
Common forms of management include eye patches—a common and typically standard form of amblyopia treatment often worn anywhere from 2 to 6 hours a day, depending on the severity—glasses or eye drops.
In comparison: The Luminopia platform features a virtual reality (VR) headset.
Now a quick refresh on this platform.
Granted FDA DeNovo approval in October 2021, the Luminopia platform is the first binocular amblyopia therapy with the potential to improve the visual acuity (VA) of the following patient base:
- Pediatric patients associated with anisometropia and/or mild strabismus
- Target age group: 4- to 7-year-olds
Go on …
While wearing this VR headset, pediatric patients watch therapeutically modified television shows (with 75 options to choose from) and movies projected at optical infinity in a controlled environment (such as at home).
- The duration: Once per day, six days a week
How it works: Through a novel dual-action mechanism, the program’s proprietary software algorithms modify content in real time and present it differently for each eye to rebalance the input to the brain.
- The intended result: teaching patients to use both eyes in a binocular manner
Gotcha. Now talk about the basis for this new data.
The findings are based on the Patients Using Prescription Luminopia (PUPiL) Registry, which collects RWD from patients prescribed to use the Luminopia platform.
The patients: Participants with similar baseline characteristics to those from the phase 3 randomized clinical trial (RCT) used to support Luminopia’s FDA clearance.
- Specifically: Those diagnosed with amblyopia associated with anisometropia, mild strabismus, or both
And what were those findings?
The platform achieved both primary safety and efficacy end points for the target age group (aged 4 to 7) of amblyopia patients when examined over a 12-week period.
At 12 weeks, patients’ amblyopic eye VA improved by:
- Treatment group (n=45):
- 1.8 lines (95% confidence interval [CI], 1.4–2.3 lines; n = 45)
- Comparison group (n = 45):
- 0.8 lines (95% CI, 0.4–1.3 lines; n = 45)
See here for more findings, published in Ophthalmology in September 2021.
How does that compare to this new RWD?
Luminopia reported that 179 participants across 10 clinical sites demonstrated “significant improvement” in VA after 12 weeks, with an 83% median treatment adherence.
Plus: Patient subgroups with the following varying characteristics “all showed significant vision improvement after 12 weeks of treatment”:
- Amblyopia severity and type
- Prior treatment experience
- Age
Plus: No safety events were noted.
So … what does all this mean?
The data confirm “the efficacy of Luminopia in the real world” and, most importantly, the company noted, “demonstrate its clinical benefit as both a first and second-line treatment.”
Luminopia co-founder and CEO Scott Xiao stated: “This registry data further validates that our therapy is effective, easy for young patients to use, and has significant benefit in the real world."
This data was recently presented at European and International Strabismological Association conference in Toulouse, France, as well as the Association for Research in Vision and Ophthalmology (ARVO) 2024.