Luminopia has received “de novo premarket” approval by the FDA for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the most common cause of vision loss in children.
Luminopia One is intended for the improvement of visual acuity in children aged 4 to 7 who have amblyopia, anisometropia, and/or mild strabismus, and who have followed treatment recommendations given by a competent eye-care professional.
Luminopia One is a virtual reality (VR) headset that allows patients to watch therapeutically modified TV shows and movies to improve their vision.
This is the first FDA-approved digital therapy for amblyopia in children, and more broadly, the first for a neuro-visual disorder.
Amblyopia develops when the brain and the eyes cease working together effectively, causing the brain to rely more heavily on one eye over the other, resulting in impaired vision in the weaker eye.
Amblyopia is commonly treated with spectacles and eye-patching or blurring (atropine) eye drops, which prohibit the stronger eye from being used and force the weaker eye to be used, but these methods do not train the eyes to work together.
These existing therapeutic approaches also face considerable obstacles due to poor patient compliance and social stigmas.
Luminopia collaborated with top doctors and researchers at Boston Children's Hospital and MIT's Picower Institute for Learning and Memory, as well as media firms such as Sesame Workshop, Nelvana, and Millimages, to develop a novel therapy strategy for patients.
Patients can watch videos from a selection of 700+ hours of popular, interesting, and instructional content with Luminopia One.
Proprietary algorithms change the selected videos in real-time within a VR headset to urge patients' brains to mix input from both eyes and increase weaker eye utilization.
“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents and physicians often struggle with current therapies,” David G. Hunter, MD, PhD, Ophthalmologist-in-Chief, Richard Robb Chair in Ophthalmology, Boston Children’s Hospital and advisor to Luminopia, said in a company news release.
Luminopia One is expected to be available in the second quarter of 2022, with eye care specialists prescribing it for one hour per day, six days per week, over a 12-week period, and patients using it at home.
Luminopia is pursuing coverage for the therapy as a pharmacy benefit with regional and national payers across the United States to enable access for children and families in need of innovative amblyopia medicines.
Luminopia One received FDA approval based on positive results from various clinical trials, including a phase 3 pivotal trial published recently in Ophthalmology that showed the therapeutic's safety and efficacy in amblyopia children aged 4 to 7.
This was the first randomized controlled trial of a new amblyopia therapy in over a decade, and the first to indicate efficacy of a novel binocular strategy.
In this phase 3 trial, 105 children were randomly assigned to either the treatment group (Luminopia One + glasses) or the control group (glasses only).
As early as four weeks, a statistically significant difference in visual acuity improvement across groups was seen.
The weak eye visual acuity of patients in the treatment group increased 1.8 lines on average on a logMAR eye chart at the 12-week primary endpoint, compared to 0.8 lines in the control group. The difference in improvement between groups was substantial (P=0.001).
Furthermore, in the treatment group, 62% of patients demonstrated a strong response, defined as a 2-line or larger improvement, compared to 33% in the control group.
Importantly, 84% of patients in the treatment group had previously received patching or atropine therapy but still had amblyopia, and Luminopia One was as effective in this category.
Over the course of the research, the median adherence to the prescribed dosage was 88%, far greater than the 48% reported in prior patching studies.
The Cleveland Clinic, UCLA Jules Stein Eye Institute, Duke Eye Center, Ann & Robert H. Lurie Children's Hospital of Chicago, Texas Children's Hospital, and Children's Hospital of Philadelphia were among the 21 academic and community sites that participated in the study.
There were no major side effects reported.