The FDA has approved the Luminopia One digital therapy device for pediatric amblyopia, or lazy eye.
The device is approved for children aged 4-7 years with anisometropia and / or strabismus and is available by prescription only. Using a virtual reality headset, the device plays therapeutically modified television programs and movies that help correct the vision defect.
FDA approval is the first for a neurovisual disorder, according to device maker Luminopia.
“FDA approval of a new digital therapy with strong clinical evidence for children with 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 doctors 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 over 700 hours of video programming modified using proprietary algorithms to promote the use of weaker eyes and to train the brain to combine visual inputs from both eyes.
Support for FDA approval came from several 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 it. ‘atropine. After 12 weeks of follow-up, children randomized to Luminopia One had an average improvement of 1.8 lines on a logMAR (logarithm of minimum resolution angle) eye map compared to 0.8 for a control group assigned to glasses. (P= 0.001). In addition, 62% of patients in the Luminopia One group had a strong response (improvement ≥ 2 lines) compared to 33% in the control group.
According to the company’s statement, Luminopia plans to make the device available in the United States during the second quarter of 2022.
Last updated on October 21, 2021