Luminopia One is one of few digital therapeutics to receive FDA approval via the de novo pathway, and it is the first for amblyopia, and for a neuro-visual disorder in general.
On October 20, 2021, Luminopia, a digital therapeutics company, announced that they have received de novo premarket approval from the U.S. Food and Drug Administration (FDA) for their virtual reality (VR) headset therapy for amblyopia, Luminopia One.
Luminopia One is a digital therapeutic that improves children’s vision via virtual reality headset. By viewing therapeutically modified TV shows or movies, children can engage with familiar content while undergoing neuro-visual therapy. The headset is indicated for improved visual acuity in children ages 4-7 with amblyopia, associated with anisometropia or mild strabismus, after receiving treatment instructions from a trained eye care professional.
“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents and physicians often struggle with current therapies,” said David G. Hunter, MD, PhD, Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston Children’s Hospital and advisor to Luminopia. “The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.”
Amblyopia (lazy eye) is the leading cause of vision loss in children. The condition is characterized by reduced vision without a structural ocular or optic nerve abnormality as a singular cause. Traditionally, it has been treated with eye patches or vision-blurring eye drops in an attempt to train the eye with poorer vision. However, this often results in poor patient adherence, and it does not promote binocular cooperation.
Luminopia One is designed to train the brain to combine input from both eyes as well as stimulating the weaker eye usage.
By partnering with media companies, such as Sesame Workshop, Nelvana and Millimages, the company has provided 700+ hours of enjoyable content for patients of all ages. Clinicians have created proprietary algorithms to modify the selected videos in real time within the VR headset. Luminopia One is intended for prescription and home use only.
Luminopia announced the publication of a phase 3 clinicial trial in September, establishing safety and efficacy, which supported the application to the FDA. Luminopia One is one of few digital therapeutics to receive FDA approval via the de novo pathway, and it is the first for amblyopia, and for a neuro-visual disorder in general.
Learn more about Luminopia One on the Luminopia website.
Boston Children’s Hospital holds equity in Luminopia. David Hunter, MD, PhD, Ophthalmologist-in-Chief at Boston Children’s Hospital is an advisor to Luminopia and holds equity.