Luminopia Announces FDA Approval of Luminopia One, First Digital Therapeutic Using TV Shows to Treat Amblyopia in Children

Today, Luminopia, Inc. announced that the U.S. FDA has approved its Luminopia One system for marketing as a prescription therapy to improve vision in children with amblyopia. Amblyopia is the leading cause of vision loss in children. Eligible patients for Luminopia One treatment are children aged 4 to 7 with amblyopia associated with strabismus or anisometropia (a difference in refractive error between the two eyes). Luminopia One enables pediatric patients to use a virtual reality (VR) system to improve their vision by watching television programs or movies modified by specific algorithms. The press release noted that this is the first digital therapy approved by the FDA for treating amblyopia in children.

Amblyopia affects nearly 3% of children due to a lack of coordination between the brain and the eyes, causing the brain to rely primarily on one eye and resulting in reduced vision in the other. Conventional treatment typically involves patching the stronger eye along with corrective glasses to encourage the use of the weaker eye. However, this method does not train the two eyes to work together in coordination. Moreover, the potential negative social and psychological impacts of wearing an eye patch limit treatment adherence.

The Luminopia One system was jointly developed by researchers from Luminopia, Boston Children's Hospital, and MIT. It utilizes a proprietary algorithm to adjust the images patients view in the VR system, promoting the use of the weaker eye and encouraging the patient's brain to integrate visual signals from both eyes.

The approval of this system is supported by positive data from multiple clinical trials, including a pivotal Phase 3 clinical trial. The results were recently published in the journal *Ophthalmology*. In this study, 105 children aged 4 to 7 years were randomized to receive treatment with either the Luminopia One system combined with glasses or glasses alone. Statistically significant differences in visual acuity improvement between the two groups were observed after 4 weeks of treatment. At 12 weeks of treatment, visual acuity in the amblyopic eye improved by an average of 1.8 lines (measured using a logMAR chart) in the Luminopia One group, compared with 0.8 lines in the control group (p=0.001).

Moreover, 62% of patients in the Luminopia One group achieved a visual acuity improvement of 2 or more lines, compared with 33% in the control group.

References:

[1] Luminopia Announces FDA Approval of Digital Therapeutic that Uses TV Shows to Improve Vision in Children with Lazy Eye. Retrieved October 20, 2021, from https://www.businesswire.com/news/home/20211020005896/en

(Original text abridged)

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