Luminopia is a company that has developed a novel digital therapeutic for treating amblyopia (lazy eye) in children. Their lead product, Luminopia One, received FDA approval in October 2021 through the de novo pathway. Luminopia One is a software-based therapeutic that allows children aged 4-7 years with amblyopia associated with anisometropia and/or mild strabismus to watch therapeutically modified TV shows and movies within a virtual reality (VR) headset.
The treatment works by using proprietary algorithms to modify the video content in real-time, promoting weaker eye usage and encouraging the brain to combine input from both eyes. This binocular approach is different from conventional treatments like patching or eye drops, which only penalize the stronger eye. Luminopia One has been validated through clinical trials, including a Phase 3 pivotal trial that demonstrated its safety and efficacy in the indicated patient population.
Luminopia's therapy is engaging for children, with a selection of over 700 hours of popular and educational content from companies like Sesame Street, Nickelodeon, and DreamWorks. This increased engagement has led to high treatment adherence rates of around 85% in clinical studies. In June 2023, Luminopia raised USD 16 million in an oversubscribed Series A financing round to support the commercial rollout of their amblyopia therapeutic.
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