A strabismus and amblyopia treatment which uses a virtual reality (VR) headset to treat binocular vision has been approved for use in eight- to 12-year-old patients by the US Food and Drug Administration (FDA). The extension for use in older children follows the FDA’s 2021 approval of the Luminopia device to treat those aged four- to seven years-old with amblyopia associated with anisometropia and/or mild strabismus.
It's rare for the FDA to provide clearance based on real-world evidence alone, said Scott Xiao, Luminopia's co-founder and CEO. “As far as we're aware, this is the first instance of it being done in ophthalmology. The FDA's decision is a testament to the rigorous design of the ‘Pupil Registry’ (a database of 500 US patients using Luminopia) and the strength of our product's safety and efficacy."
Luminopia's VR headset allows patients to watch a selection of 1,100+ hours of TV shows and movies while algorithms overlay images in real-time to promote weaker-eye usage. Offering shows including Sesame Street and SpongeBob SquarePants, Luminopia said clinical studies have shown its device encourages patient engagement and can lead to significantly improved vision after 12 weeks. Patients in the Pupil Registry were treated with traditional therapies for an average of 1.8 years prior to switching to Luminopia and they still gained an additional line of vision, said the company.
