Luminopia, Inc.
Developer of a prescription, VR-delivered digital therapeutic for pediatric amblyopia. Designs real-time video modification software that delivers dichoptic visual stimuli via qualified VR headsets, conducts randomized trials and a real-world registry to evaluate safety and effectiveness, and operates prescription fulfillment, patient access, and clinician monitoring services in the U.S. The therapeutic is FDA-cleared for pediatric use in the indicated age range.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Prescription VR-delivered binocular digital therapeutic for amblyopia
A prescription-only digital therapeutic delivered via a qualified VR headset that presents dichoptic visual stimuli to improve visual acuity in pediatric amblyopia patients during prescribed daily sessions.
Prescription VR-delivered binocular digital therapeutic for amblyopia
A prescription-only digital therapeutic delivered via a qualified VR headset that presents dichoptic visual stimuli to improve visual acuity in pediatric amblyopia patients during prescribed daily sessions.
Services
Insurance verification, reimbursement assistance, enrollment, and monthly billing workflows provided via a partner pharmacy.
Cloud-based portal displaying weekly and overall adherence trends and patient progress, with role-based access for clinic staff.
EHR integration guidance, enrollment forms, prescribing/coding references, appeal templates, and field demos for clinician adoption.
Customer and technical support via phone and email for setup, billing, and treatment questions.
Insurance verification, reimbursement assistance, enrollment, and monthly billing workflows provided via a partner pharmacy.
Cloud-based portal displaying weekly and overall adherence trends and patient progress, with role-based access for clinic staff.
EHR integration guidance, enrollment forms, prescribing/coding references, appeal templates, and field demos for clinician adoption.
Customer and technical support via phone and email for setup, billing, and treatment questions.
Expertise Areas
- Digital therapeutics for neuro-visual disorders
- Clinical trial design and execution in pediatric ophthalmology
- Real-world evidence generation and registry management
- Regulatory strategy for medical device de novo/clearance
Key Technologies
- Virtual reality delivery for medical use
- Dichoptic display and masking techniques
- Real-time video modification algorithms
- Cloud-based clinician portal and analytics
News & Updates
Phase 3 randomized controlled trial published in Ophthalmology reporting safety and efficacy of a dichoptic digital therapeutic for amblyopia.
Multiple 2024–2025 conference posters and registry reports presenting real-world outcomes and adherence data from a treatment registry.
Economic analysis published in Ophthalmology (January 2025) evaluating cost-effectiveness of digital amblyopia therapies.
Regulatory clearance via the FDA de novo pathway for prescription at-home use in pediatric amblyopia, with indicated use documented for the pediatric age range referenced in directions for use.
Phase 3 trial demonstrated statistically significant improvement in best-corrected visual acuity at 12 weeks compared with corrective refraction alone (pivotal trial results reported in Ophthalmology).
Multiple peer-reviewed and conference abstracts reporting registry outcomes and adherence in broader pediatric populations.
Phase 3 randomized controlled trial published in Ophthalmology reporting safety and efficacy of a dichoptic digital therapeutic for amblyopia.
Multiple 2024–2025 conference posters and registry reports presenting real-world outcomes and adherence data from a treatment registry.
Economic analysis published in Ophthalmology (January 2025) evaluating cost-effectiveness of digital amblyopia therapies.
Regulatory clearance via the FDA de novo pathway for prescription at-home use in pediatric amblyopia, with indicated use documented for the pediatric age range referenced in directions for use.
Phase 3 trial demonstrated statistically significant improvement in best-corrected visual acuity at 12 weeks compared with corrective refraction alone (pivotal trial results reported in Ophthalmology).
Multiple peer-reviewed and conference abstracts reporting registry outcomes and adherence in broader pediatric populations.