The Luminopia One VR 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.

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 developed closely with leading physicians and neuroscientists that has been validated through a series of clinical trials, including a prospective, randomized controlled trial.

Luminopia One has been approved by the FDA for prescription use, and is indicated for improvement in visual acuity in amblyopia patients aged 4-7.

By viewing therapeutically modified TV shows or movies, children can engage with familiar content while undergoing neuro-visual therapy.

“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.”