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# FDA OKs Luminopia One for Lazy Eye
- URL: https://www.fdaweb.com/fda-oks-luminopia-one-for-lazy-eye/
- Published: 2021-10-21T12:00:00.000Z
- Updated: 2026-09-14T17:19:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150416

FDA has granted de novo premarket approval to Luminopia for its Luminopia One as a prescription therapy to improve vision in children with amblyopia, also known as lazy eye. The company [says](https://www.businesswire.com/news/home/20211020005896/en/Luminopia-Announces-FDA-Approval-of-Digital-Therapeutic-that-Uses-TV-Shows-to-Improve-Vision-in-Children-with-Lazy-Eye?ref=fdaweb.com) Luminopia One is indicated for improving visual acuity in children with amblyopia aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional. The therapy allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality headset.

Luminopia says theirs is the first FDA-approved digital therapeutic for children with amblyopia and, more broadly, the first for a neuro-visual disorder.

The approval was based on positive data from multiple clinical trials, the company says, including a Phase 3 pivotal trial that was the first successful trial of a new amblyopia therapy in more than 10 years and the first to show the efficacy of a novel, binocular approach.