About Amblyopia
Amblyopia, or lazy eye, is the leading cause of vision loss in children.
Disease Overview
Amblyopia, or lazy eye, is a neuro-visual disease where patients have significant vision loss in one eye caused by a deficit in the brain, as opposed to an issue with the eye. It affects 3% of all children, making it the leading cause of vision loss in kids. If left untreated, amblyopia can lead to permanent vision loss and increase the risk of lifetime blindness.
There is a common misconception that all patients with amblyopia will have a wandering eye (also known as strabismus), but this is only the case in some patients. Amblyopia may also develop as a result of anisometropia (a difference in refractive error between the eyes) or a cataract. In all cases, the brain gets used to receiving a poorer image from one eye compared to the other, and learns to ignore the input from the weaker eye, leading to vision loss.
Amblyopia is usually identified as part of vision screening done by school nurses or pediatricians. Once diagnosed, amblyopia is primarily managed in the US by a group of 1200 pediatric ophthalmologists. Since traditional treatments become less effective as kids get older, it is critical for patients to begin treatment as early as possible.
Patients with amblyopia are:
2.6x
more likely to develop vision loss in both eyes1
2.9x
less likely to complete a university degree2
1.7x
more likely to develop ADHD3
1 - van Leeuwen R, Eijkemans MJ, Vingerling JR, Hofman A, de Jong PT, Simonsz HJ. Risk of bilateral visual impairment in individuals with amblyopia: the Rotterdam study. Br J Ophthalmol. 2007;91(11):1450-1451.
2 - Chua B, Mitchell P. Consequences of amblyopia on education, occupation, and long term vision loss. British Journal of Ophthalmology 2004;88:119-1121.
3 - Kim, M., Lee, S., Lee, J.E. et al. A nationwide cohort study on the risk of ADHD in children with amblyopia mediated by fine motor skill impairment in East Asia. Sci Rep 2022;12:6932.
Traditional Treatments
Glasses
Most patients receive glasses to correct the refractive error - however, glasses often do not treat the underlying issue in the brain.
Patching
The standard-of-care treatment today is wearing a patch over the stronger eye, to force patients to use their weaker eye.
Atropine
Atropine drops which blur the stronger eye are also used in some cases, typically when patching is not enough to restore normal vision.
The unmet need
Although traditional therapies have been around for decades, they leave a significant unmet need for patients. Compliance with patching and atropine is notoriously difficult1, and patching can come with a harmful social stigma for children.
Even when patients are compliant, many are still left with the disease after treatment. One nationwide study found that 75% of patients still had significant vision loss after going through patching2. Another recent paper determined that patching and atropine only provide 0.4-0.7 lines of vision improvement beyond glasses alone on a standard eye-chart3.
There is an urgent need for new treatment options that are more engaging and effective for patients. It is important that future therapies also teach patients to use both eyes together properly, instead of just blurring the stronger eye image.
1 - Wallace MP, Stewart CE, Moseley MJ, et al. Compliance with occlusion therapy for childhood amblyopia. Invest Ophthalmol Vis Sci. 2013;54(9):6158-6166. Published 2013 Sep 17.
2 - Wallace DK; et al. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Ophthalmology. 2006;113(6):904-912.
3 - Li, Y., Sun, H., Zhu, X. et al. Efficacy of interventions for amblyopia: a systematic review and network meta-analysis. BMC Ophthalmol 20, 203 (2020).
Indications, Safety and Warnings
Indications:
Luminopia is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia 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. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia therapy. Luminopia is intended for Prescription Use Only, in an at-home environment.
Safety:
In the Luminopia pivotal trial, 14 patients (25%) experienced adverse events in the treatment group vs. 8 (14%) in the control group. Ocular AEs were reported in 6 (11%) patients in the treatment group and 8 (14%) patients in the control. No serious adverse events (AEs) were reported. The most frequent non-serious AE potentially related to Luminopia was headache (14.3%), for which all cases were graded as mild, transient, and resolved without sequelae.
Warnings:
Rx only: Federal law restricts this device on the order of a trained eye-care professional.
Safety and effectiveness of Luminopia beyond 12 weeks is unknown. The long-term effects of HMD use in patients 4-7 years of age are unknown. Patients with a history of light-induced seizures, or serious medical conditions, should contact a doctor before using Luminopia. Patients should only use Luminopia while wearing their prescribed glasses under the HMD. Patients should stop using Luminopia and contact a doctor if they experience a new or worsened eye-turn, or double vision. Patients with an interpupillary distance of less than 52 mm should not use Luminopia.
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