Luminopia Inc.

Clinical Data

Efficacy and Safety Demonstrated Across 3 Trials at 23 Sites in Over 200 Patients

Strong Efficacy In Randomized Controlled Phase 3 Trial

Similar Benefit Seen in Patients With or Without Prior Treatment

84% of Luminopia patients received treatment beyond glasses prior to the trial


94% of prior treated patients had been patched

Patching DurationTreatmentControl
>3 Months88% (n=30) 72% (n=23)
>6 Months56% (n=19) 47% (n=15)

Patients with Mild Strabismus Gained Similar Benefit

Patients with <= 5 PD of heterotropia at distance were enrolled

High rate of strong responders

High Adherence and Preferred by Parents

Patient Adherence

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Dose:
1 hr/day, 6 days/week

Parent Preference

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Prefer Luminopia
over patching

Safety

No serious adverse events were reported.

Non-Serious Adverse Events1
Treatment Group2 (N=56)Control Group2 (N=59)
Headache38 (14.3%)1 (1.7%)
New heterotropia4 (7.1%)4 (6.8%)
Worsening BCVA3 (5.4%)4 (6.8%)
Eye strain2 (3.6%)0 (0.0%)
Worsening Heterotropia0 (0.0%)1 (1.7%)
Other44 (7.1%)0 (0.0%)
Overall14 (25.0%)8 (13.6%)

1 - Includes events classified with Possible, Probable, or Definite relation to study treatment. Data presented as: n (%). Participants may experience more than one AE.

2 - As Treated Population is defined as subjects with > 0% adherence of device use are in the treatment arm, otherwise control; there were no control subjects treated with the device.

3 - All cases of headaches were graded as mild in severity and all resolved without sequelae by the end of the study.

4 - Other AEs in treatment group include: Eye Twitch, Facial Redness, Increase in Frequency of Night Terrors, Dizziness, Parent-reported intermitted eye turning when tired.

Luminopia Publications

Several peer-reviewed papers and abstracts have been published on the Luminopia technology by top journals in the field.

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Modeling amblyopia treatment responses through principles of synaptic plasticity

Blais B, Gaier ED, Xiao S. IOVS 2022;63(7):1236-A0344.

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Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia

Xiao S, Angjeli E, Wu HC, et al. Ophthalmology. 2022;129(1):77-85.

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Digital Therapeutic Improves Visual Acuity and Encourages High Adherence in Amplyopic Children in Open-Label Pilot Study

xiao s, gaier eD, wu HC, et al. Journal of AAPOS 2021;25(2):87.e1-87.e6

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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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