FDA OKs Luminopia One for Lazy Eye

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 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.