The new digital therapeutic enables patients to watch therapeutically modified TV shows and movies to enhance their vision within a virtual reality (VR) headset
The FDA has approved Luminopia’s digital therapeutic to enhance vision in children with lazy eye. (Credit: Pixabay)
Digital therapeutics company Luminopia has secured de novo premarket approval from the US FDA for its digital therapeutic, which uses TV shows to enhance vision in children with amblyopia (lazy eye).
Luminopia One as a prescription therapy is indicated for enhancement in visual acuity in children with amblyopia aged between four and seven years and associated with anisometropia or mild strabismus.
The new digital therapeutic enables patients to watch therapeutically modified TV shows and movies to enhance their vision within a virtual reality (VR) headset.
It is claimed to be the first FDA-approved digital therapeutic for children with amblyopia, as well as the first one for a neuro-visual disorder.
Luminopia worked with clinicians and researchers at Boston Children’s Hospital and the Picower Institute for Learning and Memory at MIT to develop a new therapeutic approach for patients.
The company has also involved media companies such as Sesame Workshop, Nelvana and Millimages in the development of the new therapeutic.
Luminopia CEO Scott Xiao said: “We’re proud to be part of the FDA’s groundbreaking decision today, to approve a first-of-its-kind digital therapeutic that allows patients to watch their favorite TV shows and movies to improve their vision.
“We would like to thank our partners, advisors, study participants and team members for getting us here, and we are excited to bring Luminopia One to children with amblyopia across the country.
“This important milestone also opens the door for us to adapt our technology to create engaging digital therapeutics for other neuro-visual disorders.”
Luminopia is planning to launch the new therapeutic in the second quarter of next year. It will be prescribed by eye care professionals for one hour per day, and six days per week for 12-week periods for use at home by patients.
The approval is based on data from multiple clinical studies, including a phase 3 pivotal trial that shown the therapeutic’s safety and efficacy in amblyopia patients aged between four and seven years.