Luminopia, Inc. announced FDA clearance for an expansion to the existing label of its binocular digital therapy platform for pediatric patients diagnosed with amblyopia.
First things first: Talk about Luminopia (the company).
Spun out from Harvard University, the commercial-stage company has partnered with Boston Children’s Hospital on one main purpose:
- Clinically advancing its digital therapeutic platform (also named Luminopia) and working together to co-develop additional virtual and augmented reality (VR/AR) treatments for significant neuro-visual disorders.
Now Luminopia, the platform.
What it is: The first binocular amblyopia therapy with the potential to improve visual acuity (VA) in pediatric patients associated with anisometropia and/or mild strabismus.
- To note: The target age for this pediatric patient base is the subject of this expanded clearance, so read on for those details.
Its regulatory status: The platform was granted FDA De Novo approval (reserved for novel medical devices) in October 2021.
- Read up on this regulatory classification request.
Editor’s note: Check out this November 2023 interview with Luminopia’s Co-Founder and CEO Scott Xiao speaking with Glance President Jaclyn Garlich, OD, FAAO, on the platform ranking among TIME magazine’s best inventions of the year.
So how does this platform work?
In general: Luminopia is designed as an alternative prescription-based therapy for amblyopia, which is typically treated with eye patches, glasses, or atropine eye drops.
Specifically: The VR platform encompasses a VR headset that patients wear (on top of their glasses) to stream and watch therapeutically-modified television shows and movies (with 75 options to choose from) that are projected at optical infinity in a controlled environment—such as at home.
- The duration: Once a day, six days a week.
And how exactly do these shows and movies treat amblyopia?
Each movie and show streamed through the headset is projected via a novel dual-action mechanism involving the program’s proprietary software algorithms that modify (in real time) and present the media differently for each eye.
The intent: To replace the input to the brain and teach patients to use both eyes in a binocular manner—thus resolving amblyopia.
Nice! And what age group of patients is this designed for?
Luminopia’s initial FDA clearance included an indication for amblyopia patients ages 4 to 7 only.
Now to this expanded clearance.
Quite simply: This new FDA approval expands the permitted age group of amblyopia patients to include those ages 8 to 12.
As such: The new indication for the VR headset is for patients aged 4 to < 13 years old with amblyopia associated with anisometropia and/or mild strabismus.
And what kind of clinical data supported the FDA’s decision?
That would be real-world evidence stemming from “the largest amblyopia treatment registry to date,” according to the company.
Specifically: Updated results from the Patients Using Prescription Luminopia (PUPiL) Registry (NCT06429280).
Tell me about this registry.
The PUPiL Registry is an ongoing collection of real-world data based on 500+ patients prescribed to use the Luminopia platform across 14 academic and community centers in the United States.
Notably: These patients exhibit similar baseline characteristics to those included in the phase 3 randomized clinical trial whose data (published in Ophthalmology in 2021) supported the platform’s initial regulatory clearance.
- See here for those details—which included patients’ amblyopic eye VA improving by 1.9 lines over a 12-week period—and click here for additional RWD released in June 2024.
So what did this updated RWD show?
Per Luminopia: “The FDA determined that the platform’s safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years.”
Supporting this finding even further: Prior to using Luminopia, patients included in the PUPiL Registry were also treated with more traditional amblyopia therapies for an average of 1.8 years.
- The results: These patients were reportedly still able to gain an additional line of vision.
And the overarching significance?
As Luminopia’s Xiao noted, the FDA’s clearance of a device based on RWD alone is rare.
“As far as we’re aware, this is the first instance of it being done in ophthalmology,” he stated.
Nice! So, how can I prescribe this for my amblyopia patients?
Luminopia is available prescription-only through CoAssist. Click here to learn how to get started (and watch a how-to video).