FDA issues premarket approval for novel digital amblyopia therapy
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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. Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents and physicians often struggle with current therapies,” Luminopia advisor David G. Hunter, MD, PhD, ophthalmologist-in-chief and Richard Robb Chair in Ophthalmology at Boston Children’s Hospital, said in the release. “The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.”
Luminopia plans to launch the therapy in the second quarter of 2022.
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