Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Luminopia’s new FDA-approved therapy uses TV to treat lazy eye in kids

October 20, 2021 By Sean Whooley

LuminopiaLuminopia announced today that it received FDA de novo approval for its prescription therapy for improving vision in children with lazy eye.

Cambridge, Massachusetts-based Luminopia’s prescription Luminopia One holds indication for improvement in visual acuity in children between ages four and seven with lazy eye (amblyopia) associated with anisometropia and/or mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional, according to a news release.

“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,” Boston Children’s Hospital Ophthalmologist-in-Chief & Richard Robb Chair in Opthalmology & advisor to Luminopia Dr. David G. Hunte said in the release. “The idea of prescribing TV shows and movies to treat amblyopia in children instead of eye patches or eye drops is an exciting prospect.”

The Luminopia One platform allows patients to watch therapeutically modified TV shows and movies to improve vision within a virtual reality (VR) headset. The company said it is the first FDA-approved digital therapeutic for children with amblyopia and, more broadly, the first for a neuro-visual disorder.

Luminopia One offers more than 700 hours of popular, engaging and educational content from which users can choose, with proprietary algorithms included to modify the selected videos in real-time within a VR headset to promote weaker eye usage and encourage patients’ brains to combine input from both eyes.

“We’re proud to be part of the FDA’s groundbreaking decision today, to approve a first-of-its-kind digital therapeutic that allows patients to watch their favorite TV shows and movies to improve their vision,” Luminopia CEO Scott Xiao said. “We would like to thank our partners, advisors, study participants and team members for getting us here, and we are excited to bring Luminopia One to children with amblyopia across the country. This important milestone also opens the door for us to adapt our technology to create engaging digital therapeutics for other neuro-visual disorders.”

Luminopia expects to launch the platform in the second quarter of 2022. The prescription of the therapeutic will be for at-home use at a clip of one hour per day, six days per week, over 12-week periods.

The company received approval thanks to positive data from multiple clinical trials, including its recently published Phase 3 pivotal trial that demonstrated safety and efficacy in 105 randomized children. At the 12-week primary endpoint, the weak eye visual acuity of patients in the treatment group improved 1.8 lines on average on a logMAR eye chart, compared to a 0.8-line improvement in the control group, proving statistically significant.

Related Articles Read More >

DeepWell Digital Therapeutics Mike Wilson Ryan Douglas
How DeepWell is developing video games as tools for treating medical conditions
Zimmer Biomet OptiVu Surgical Demo
Zimmer Biomet introduces OptiVu mixed reality platform, demos new ZBEdge offerings
Life Spine
Life Spine wins FDA clearance for ProLift micro expandable spacer
Artificial intelligence
6 startup trends from Deloitte and MedTech Innovator — and warnings for established medtechs

DeviceTalks Weekly.

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech