The FDA has granted de novo premarket approval for Luminopia One, a digital therapy for children aged 4 to 7 years with amblyopia, according to a press release from Luminopia.
The therapy, which allows patients with amblyopia associated with anisometropia and/or mild strabismus to view modified TV shows and movies to improve their vision using a virtual reality headset, previously showed positive results in a phase 3 pivotal trial.
“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. (Read more...)