by Charles Bankhead, Senior Editor, MedPage Today October 21, 2021

The FDA approved the digital therapeutic device Luminopia One for pediatric amblyopia, or lazy eye.

The device is approved for children ages 4 to 7 years with anisometropia and/or strabismus and is available by prescription only. By means of a virtual reality headset, the device plays therapeutically modified television programs and movies that help correct the vision abnormality.

The FDA approval is the first ever for a neurovisual disorder, according to device manufacturer Luminopia.

"The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development," said David G. Hunter, MD, PhD, of Boston Children's Hospital, in a statement. "Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents, and physicians often struggle with current therapies. The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect."

The device has a library of more than 700 hours of video programming modified by means of proprietary algorithms to promote weaker-eye usage and to train the brain to combine visual input from both eyes.

Support for FDA approval came from multiple clinical trials, including a pivotal phase III randomized trial involving 105 children with amblyopia, more than 80% of whom had used eye patches or had been treated with atropine. After 12 weeks of follow-up, children randomized to the Luminopia One had a mean improvement of 1.8 lines on a logMAR (logarithm of the minimum angle of resolution) eye chart as compared with 0.8 for a control group assigned to eyeglasses (P=0.001). Moreover, 62% of patients in the Luminopia One group had a strong response (≥2 line improvement) versus 33% of the control group.

According to the company statement, Luminopia expects to make the device available in the U.S. during the second quarter of 2022.

Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow

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