Luminopia is the first FDA-approved* binocular therapy for lazy eye (amblyopia). Luminopia modifies more than 1,100 hours of popular TV shows into treatment in real-time inside a lightweight, immersive VR headset. Our software algorithms take the content, modify it in real-time, and present it differently to each eye to rebalance the input to the brain, which has been shown to improve vision over time in appropriate patients with amblyopia.
*De Novo granted in Oct 2021.
Luminopia can be prescribed by a trained eye-care professional in the United States.
Luminopia has been tested in 3 clinical trials with over 200 patients. Our gold standard Phase 3 pivotal trial demonstrated the safety and effectiveness of Luminopia in children aged 4-7 years. Patients who received Luminopia improved by 1.8 lines on average on a standard eye-chart after 12 weeks compared to 0.8 lines of improvement in the control group, which received glasses only.
No, we will provide a qualified headset for you to use for the duration of treatment with Luminopia.
The Luminopia software works on compatible off-the-shelf VR headsets included in the Directions For Use. Once you receive a prescription for Luminopia, treatment consists of watching TV for 1 hour a day, 6 days a week.
Luminopia is indicated for the improvement in vision of amblyopia patients age 4-7 who are either new to treatment or have tried other treatments like eye-patching or atropine eye drops.
Luminopia received marketing authorization from the FDA as a prescription-use medical device, and therefore, it is only available under the supervision of an eye-care professional.
The American Academy of Pediatrics does not have specific screentime guidelines and recommends considering the quality of interactions with digital media and not just the quantity, or amount of time. We work with trusted networks to ensure content is properly rated for our patient population. In addition, one of the benefits of using a VR headset is that the TV shows are projected at “optical infinity” (or far in the distance) so you don’t have to worry about any risks of your child sitting too close to a screen.
In the Luminopia Phase 3 pivotal trial, 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 on their own. No cases of nausea, worsening myopia, or reverse lazy eye (amblyopia) were reported.
Cybersecurity and patient data privacy are very important to us. With this in mind, Luminopia was designed based on industry leading standards for cybersecurity and patient data privacy. For more information, please refer to our Privacy Policy which can be found at luminopia.com/privacy.
Luminopia is committed to ensuring affordable access for all patients. The treatment is offered as a monthly prescription and the team at CoAssist Pharmacy will help you find the lowest cost possible.
No, Luminopia is prescribed on a patient-by-patient basis and the software algorithms are designed to treat amblyopia in a single patient.
We recommend that you direct any medical questions to your eye-care professional. If you have questions about your prescription or questions about the treatment, please contact the Luminopia Patient Support Line at (855) 586-4756 or support@luminopia.com.
Toward the end of each 30-day prescription, our partner pharmacy CoAssist will reach out to you directly with a reminder to confirm your refill. If you do not hear from CoAssist, please call (855) 586-4756.
Our partner pharmacy CoAssist will automatically enroll you in our Patient Access Program. They'll contact your health plan on your behalf and let you know if Luminopia is covered by your plan. If it is not, CoAssist will offer a self-pay option so you can still access the treatment.
Luminopia is a 30-day prescription, and the total duration of treatment will be determined by your eye-care professional.
Your child's doctor can learn more about Luminopia at luminopia.com or they can complete a form to have one of our Account Managers visit their office to demo Luminopia and answer any questions they may have
One hour per day, six days per week is the recommended dose authorized by the FDA based on the results of our Phase 3 pivotal clinical trial. Other treatment regimens have not been studied.
Within the application, there is a daily usage timer that shows the number of minutes remaining in your child’s treatment for the day. A pop-up will also appear at the end of each day reminding your child when treatment is over. We recommend that all patients receive at least 3 months of treatment, since this was the duration studied in our Phase 3 pivotal clinical trial. After that, your eye-care professional will determine whether your child is continuing to benefit from Luminopia and decide whether to continue treatment.
The recommended treatment regimen is 1 hour of continuous use per day.
Luminopia is designed so that children can go through treatment while sitting upright, reclining, or lying down on their back. Choose a position that is most comfortable for your child.
Parents know their children best. Luminopia is designed to be engaging for patients, and a pop-up will appear when treatment is done for the day. Remind your child to remove the headset once the pop-up appears.
There are more than 3,100 episodes from over 75 popular, kid-friendly TV shows in the library, including animated and live action. Luminopia is FDA-approved for children age 4-7 and all content is appropriate for that age group. We work with trusted networks to ensure content is properly rated for our patients. The content library is updated regularly.
Yes, your child should always wear their glasses while using Luminopia.
Yes, currently a Wi-Fi network or smartphone hotspot is required to undergo treatment with Luminopia.
The Pico G2 4K VR headset is the current VR headset qualified to work with Luminopia. We are continuously assessing new headsets and will add to this list as soon as they become qualified.
Luminopia is currently only approved for use in the United States.
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