The Food and Drug Administration (FDA) has cleared Luminopia One, a digital therapeutic, for improvement in visual acuity in children 4 to 7 years of age with amblyopia associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye care professional.
With Luminopia One, patients watch therapeutically modified TV shows and movies to improve their vision within a virtual reality (VR) headset. Patients can choose the video content and a proprietary algorithm modifies the content in real-time to balance visual input to the brain. The therapy uses a binocular approach, which promotes weaker eye usage and encourages patients’ brains to combine input from both eyes.
The approval was based on data from several clinical trials, including a phase 3 study that assessed the efficacy and safety of Luminopia One in 105 children aged 4 to 7 years with amblyopia. Patients were randomly assigned 1:1 to receive Luminopia One plus glasses (treatment group) or glasses alone (control group). The primary endpoint was change in amblyopic eye visual acuity at 12 weeks from baseline.
Results showed that amblyopic eye visual acuity improved by 1.8 lines (95% CI, 1.4-2.3) in the Luminopia treatment group compared with 0.8 lines (95% CI, 0.4-1.3) in the control group (P =.001). A statistically significant difference in visual acuity improvement between the groups was observed as early as 4 weeks. Additionally, 62% of patients in the treatment group had a 2-line or greater improvement in the weak eye vs 33% of the control group (P =.006).
Luminopia One is expected to launch in the second quarter of 2022, and will be prescribed by an eye care professional for at-home use for 1 hour per day, 6 days per week, for 12-week periods. The digital therapeutic is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. It is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the VR headset during treatment.
- Luminopia announces FDA approval of digital therapeutic that uses TV shows to improve vision in children with lazy eye. News release. Luminopia. Accessed October 20, 2021. 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.
- Luminopia One, a digital therapeutic for amblyopia, demonstrates safety and efficacy in phase 3 pivotal trial. News release. Luminopia. September 14, 2021. Accessed October 20, 2021. https://www.businesswire.com/news/home/20210914005661/en/Luminopia-One-a-Digital-Therapeutic-for-Amblyopia-Demonstrates-Safety-and-Efficacy-in-Phase-3-Pivotal-Trial.
This article originally appeared on MPR