Luminopia Gets FDA De Novo Approval for Virtual Reality Therapy for Lazy Eye

Cambridge, Mass.-based Luminopia has received the FDA’s de novo premarketing approval for Luminopia One, a prescription therapy to improve vision in children with amblyopia, a condition commonly known as lazy eye.

Amblyopia, which affects 3 percent of all children, is conventionally treated with glasses combined with eye-patching or blurring eye drops that prevent usage of the stronger eye and force usage of the weaker eye.

Luminopia One allows patients to watch “therapeutically modified” TV shows and movies to improve their vision, while using a virtual reality headset. The treatment is indicated for treatment of children ages four to seven with two eyes with different refractive powers or that do not line up with each other.