Luminopia co-founder and CEO Scott Xiao spoke with Ophthalmology Times about the PUPiL registry and how VR therapy for children with amblyopia works and could revolutionize amblyopia treatment.
Video transcript:
David Hutton:
Hi, I’m David Hutton with Ophthalmology Times, and I’m joined by Scott Xiao, co-founder and CEO of Luminopia, which recently announced that real-world data from patients using the Prescription Luminopia Registry continues to demonstrate the effectiveness of its FDA-approved treatment and improve vision in children with amblyopia. Thanks for joining us! First, tell us about the data and what it means for treating amblyopia in young children.
Scott Shao:
Yes, thank you, David. I’m glad to be here. At Luminopia, we developed the first FDA-approved binocular treatment for amblyopia, the leading cause of vision loss in young children. Despite its widespread popularity, the field has been without innovation for a long time. Until now, the standard of care has been glasses, followed by an eye patch and, for some patients, atropine eye drops. Currently, compliance with these treatments is often very low, and even for those who are compliant, many are left with vision loss. So, we embarked on this mission about seven years ago to develop a more engaging and effective way to treat amblyopia. The technology we developed allows children to watch their favorite TV shows as a treatment instead of wearing an eye patch. You can imagine that compliance would be a little easier if children could watch Spongebob Squarepants as a treatment.
But we’ve also developed a unique mechanism. So when you wear an eye patch, you put strain on your stronger eye and you only get input from one eye. So it’s more of a monocular approach. But we’re pioneering binocular therapy, where we’re rebalancing the input to both eyes, but still allowing the brain to get stimulation from both eyes. And we do that inside a VR headset. This allows us to present different images to each eye and change the TV show accordingly. This technology has been studied in multiple clinical trials, got FDA approval about two years ago, and is commercially available just over a year later. And we’re excited that top pediatric hospitals and eye institutes around the country are already prescribing it and really embracing this technology as a new treatment option for patients with this disease.
Now, the announcement that we recently made is around what we’re calling the PUPiL registry, which we created about eight months ago to look at real-world outcomes of Luminopia, which is now commercially available. The main difference between this registry and the clinical trial data that we’ve published in the past is that this is real-world outcomes. There are very few eligibility criteria with the registry, and we want to capture outcomes for nearly every patient that a physician determines to be an appropriate candidate for Luminopia. There are two things that we really want to understand: how is this technology, now that it’s available by prescription, being used in the real world, what are the outcomes, and how do they compare to what we’ve seen in clinical trials?
We’re very excited about the results that we’ve seen so far from the PUPiL registry, and we’ve seen benefit across a very broad range of patients. So we’re seeing benefit in both the approved age group of 4-7 years old. We’re seeing benefit in older children who are struggling with existing treatment options. We’re seeing mild cases of amblyopia and severe cases of amblyopia, and we’re seeing benefit in all of those subgroups. That’s one of the really important findings. The other really important finding is that we looked at a patient population that matched the patient population in the pivotal trial from a demographic standpoint. This is because we really wanted to understand how well our real-world results matched up to what we actually saw in the trial. We saw very similar visual acuity improvements in that subgroup of patients. We saw a 1.8 line visual acuity improvement in the clinical trial, but in the real world we saw about a 1.7 line visual acuity improvement in that subgroup. We see very similar adherence rates, over 80% in both the clinical trial and in the real world. So we’re very pleased with the results. While real-world results are typically much more complex than those seen in clinical trials, this is fairly consistent with our expectations and continues to reinforce the effectiveness of Luminopia as a treatment for amblyopia.
David Hutton:
You touched on this earlier, but can you tell us a bit more about how Luminopia works?
Scott Shao:
Yes. From a patient perspective, it’s as simple as picking a TV show you like, and then you use it for one hour a day, six days a week, which means you have to watch TV for that amount of time. We partner with companies like Nickelodeon, Sesame Street, and others. [and] PBS Kids will create a library of over 3,000 hours of content that patients can choose to watch during their treatment. That’s all they have to do. The treatment itself is all done through the software that we’ve created. It’s a software application that runs on a commercially available VR headset for kids. And we present a slightly different image to each eye. To explain the mechanism of action a little bit more, it’s a dual-action mechanism. First, we change the contrast of the image to encourage the brain to pay attention to the weaker eye. Typically, in patients with amblyopia, we find that the weaker eye is inhibited. So we change the contrast to overcome that inhibition. But on top of that, we use what’s called a dichoptic mask, which cuts out parts of the image for both eyes. So when the patient watches the video, they have to fit the puzzle pieces together to appreciate the whole video. And that’s what makes it a binocular approach, a binocular mechanism, which makes it very different from any treatment that’s ever been done before.
David Hutton:
What about headsets? Do I just get the software or do I need to bring my own headset?
Scott Shao:
That’s a great question, and we try to make it as easy as possible for everyone involved. For the physician, it’s as easy as writing a prescription for Luminopia, which can be done in the EHR or by fax. After that, our partner pharmacies handle the rest, including actually shipping the headset to the family. Families don’t need to provide their own headset, they just need WiFi. They receive the headset in the mail and receive an access code from the pharmacy. They put the headset on, connect to WiFi, enter the code, and they can start treatment.
David Hutton:
Let’s take a look at the PUPiL registry. What’s the next step?
Scott Shao:
Yes, we’re excited about the evidence that will continue to be generated as the PUPiL registry expands. At the time of the first data cut and the first presentation from the registry, the number of sites was about 10. Since then, five or six more sites have joined, and that will continue to grow. So we’re excited to see the sample size continue to grow, which will allow us to answer additional scientific questions and look more deeply at subgroups. As the subgroups get larger, we can look at them in more detail. So we expect to publish more data, and many more interesting findings, from the PUPiL registry over the next few years.
David Hutton:
Finally, what feedback are you getting from doctors who prescribe this drug about the results their patients are getting?
Scott Shao:
Well, we have a lot of physicians who are really excited and grateful to have a new treatment option. A lot of the physicians that we’ve worked with have only ever used patching and atropine since they were trained as pediatric ophthalmologists or optometrists. And we want to have something else for those patients who are really struggling with patching. They’re not compliant, they don’t want to patch. Or maybe they’re patients who’ve done patching and haven’t seen the results they expected. Or maybe it’s a brand new patient who’s just newly diagnosed. We’ve shown efficacy in all these different types of patients. And we’ve seen physicians really happy to have this new tool in their toolkit to be able to treat these patients.
David Hutton:
Also, are there any other points that I didn’t ask about today that are important to note?
Scott Shao:
I think what’s really important to the audience that we’re speaking to is ease of use. I touched on this a little bit earlier. When people think about any new technology, they often assume that it’s going to be complicated to actually implement and get it to patients, but we’ve made it a priority to make it as easy as possible. From a physician’s perspective, they just write a prescription for our product, send it to our partner pharmacy, and we take care of the rest.
