LUMINOPIA

Luminopia Announces FDA Approval of Digital Therapeutic that Uses TV Shows to Improve Vision in Children with Lazy Eye

Retrieved on: 
Wednesday, October 20, 2021

Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset.

Key Points: 
  • Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset.
  • The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development.
  • 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 One is the first FDA-approved digital therapeutic for a neuro-visual disorder in children, indicated to improve vision in children with amblyopia.

Luminopia One, a Digital Therapeutic for Amblyopia, Demonstrates Safety and Efficacy in Phase 3 Pivotal Trial

Retrieved on: 
Tuesday, September 14, 2021

The published study was a Phase 3 multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of Luminopia One to treat amblyopia in children aged 4-7.

Key Points: 
  • The published study was a Phase 3 multicenter, randomized controlled clinical trial designed to evaluate the safety and efficacy of Luminopia One to treat amblyopia in children aged 4-7.
  • A link to the publication, Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia, can be found here: https://www.aaojournal.org/article/S0161-6420(21)00682-5/fulltext .
  • Luminopia One has been validated in multiple clinical trials, including a Phase 3 pivotal trial that demonstrated its safety and efficacy in children aged 4-7 for the treatment of amblyopia.
  • Luminopia is committed to creating digital therapeutics that are both rigorously evaluated for FDA approval and genuinely engaging for patients.