Luminopia, Inc. has secured $16 million in oversubscribed Series A financing in support of its digital therapeutic platform designed to improve vision in pediatric patients diagnosed with amblyopia.
Let’s start with the company.
Based in Cambridge, Massachusetts, Luminopia was launched out of Harvard University with a focus on pioneering a new class of digital therapeutic treatments for significant neuro-visual disorders.
The commercial-stage company is an innovation partner of Boston Children’s Hospital, with the goal to “bring increased clinical rigor to [Luminopia’s digital therapeutic] platform and co-develop other virtual and augmented reality (AR) treatments for medical conditions.”
And the financing?
The company’s funding round was led by U.S. Venture Partners, a Silicon Valley venture capital firm, with added financial support from Broadfin Advisors (a new investor) and existing investors ShangBay Capital and Vertical Group.
Now this platform.
Luminopia was FDA De Novo-approved in October 2021 as the first binocular amblyopia therapy for potential improvement of visual acuity (VA) in children ages 4 to 7 with amblyopia associated with anisometropia and/or mild strabismus.
Back up … what’s an FDA De Novo approval?
This type of request functions as an alternative for classifying low- to moderate-risk devices meeting the requirements of a class I or II device and for companies wishing to market their devices without submitting a 510(k) application.
This classification is based on a risk-based process.
See here for further details, including the two options for submitting a De Novo request.
Gotcha. Any clinical data on it?
Clinical data on the platform includes, among other trials, a randomized, controlled pivotal phase 3 trial that found it achieved both primary safety and efficacy end points for the target age group of amblyopia patients.
See here for study details, published in Ophthalmology.
So how does it work?.
In lieu of wearing an eye patch, pediatric patients watch therapeutically-modified television shows and movies (one per day, 6 days a week) via a virtual reality (VR) headset.
Through a novel dual-action mechanism, the software modifies content in real time and presents it differently for each eye in order to rebalance the input to the brain—effectively teaching patients to use both eyes, together, in a binocular manner.
According to the company, the headset images are projected at optical infinity in a controlled environment (ie: at home).
Which patients should use this?
The software is designed for pediatric patients who have and have not received amblyopia treatment as an accompaniment to full-time refractive correction.
Per Luminopia, patients with more than 12 months of previous treatment (aside from refraction correction) have not been studied with the platform.
Is this widely available yet?
Not quite … right now the software is available for prescription-use only via eyecare professionals (ECPs).
Parents of amblyopia-diagnosed pediatric patients can contact their ECP to discuss this program as a potential therapeutic option.