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Today, Luminopia announced that the US FDA approved its Luminopia One system as a prescription therapy to improve the vision of children with amblyopia
Amblyopia occurs in nearly 3% of children because the brain and eyes cannot work in coordination, causing the brain to rely mainly on one eye, causing the other eye to lose vision
The Luminopia One system was developed by Luminopia in collaboration with researchers from Boston Children's Hospital and MIT
The approval of this system is supported by positive data from multiple clinical trials, including a pivotal phase 3 clinical trial
Moreover, 62% of patients in the Luminopia One group improved their vision by more than 2 lines, compared with 33% in the control group
Reference materials:
[1] Luminopia Announces FDA Approval of Digital Therapeutic that Uses TV Shows to Improve Vision in Children with Lazy Eye.