VR approach to treating amblyopia in children with Luminopia

Scott Xiao, co-founder and CEO of Luminopia, sat with Ophthalmology Times to discuss the PUPiL Registry and how the VR treatment for children with amblyopia works and can revolutionize amblyopia treatment.

Video Transcript:

David Hutton:

Hi. I'm David Hutton of Ophthalmology Times. Joining me is Scott Xiao, Luminopia co-founder and CEO. The company recently announced that real world data from the patients using Prescription Luminopia Registry continues to demonstrate efficacy of the FDA approved therapy and improving vision for children with amblyopia. Thank you so much for joining us. First, tell us about the data and what it means for the treatment of amblyopia in young children.

Scott Xiao:

Sure, thanks, David, and glad to be here. So at Luminopia, we've developed the first FDA approved by binocular treatment for amblyopia, which is the leading cause of vision loss in young children. And despite its prevalence, it's a space that hasn't had innovation in a long time. So the standard of care treatments up to this point have been glasses, followed by eye patches, and atropine drops for some patients. Now, compliance with these treatments is often very poor. And even in patients that are compliant, you see many of them are left with residual vision loss. So we set out on this mission about 7 years ago now to create a more engaging and a more effective way of treating amblyopia. And the technology that we developed, we like to say allows kids to watch their favorite TV show as treatment instead of having to wear a patch. So you can imagine compliance gets a little bit easier if the kids get to watch SpongeBob as treatment.

But beyond that, we're also pioneering a unique mechanism. So with patching, you're penalizing the stronger eye, and you're just getting input from one eye. So it's more of a monocular approach. Whereas we're pioneering a binocular treatment where we are rebalancing the input to the eyes, but still making sure that the brain is getting stimulated from both eyes. And we do that within a VR headset. That's what allows us to present a different image to each eye and modify the TV shows accordingly. The technology was studied in multiple clinical trials, and was granted FDA approval about 2 years ago, and has been commercially available for just over a year. And we're really happy to have a number of the top children's hospitals and eye institutes across the country already prescribing and they've really embraced the technology as a new treatment option for their patients with this condition.

Now, the recent announcement we put out is with regard to the–what we call the PUPiL Registry, which we set up about 8 months ago to look at the real world outcomes of Luminopia, now that it's commercially available. And the key difference between this and some of the clinical trial data we've published in the past, is this is the real world. So there's very little eligibility criteria when it comes to the registry, we're looking to understand the outcomes with pretty much any patient that a physician decides is a good candidate for Luminopia. And we really wanted to understand a couple of things. We wanted to understand how is this technology being used in the real world now that it's available for prescription? And how are the results? And how do they compare to what we saw in our clinical trial?

What we're seeing so far from the PUPiL Registry, which we're very excited about, is we're seeing a benefit in a very broad patient population. So both across our age range, the 4-7 age range that we're approved for. We're seeing some use in older kids that are struggling with existing treatment options. We're seeing mild cases of amblyopia, and severe cases of amblyopia, and we're seeing benefit across all of those subgroups. So that's one very important finding. The other very important finding is we took a look at the population of patients that matched those of our pivotal trial, from a demographic standpoint, because we wanted to understand well, how did the real world results actually match up to what we saw in our trials. And in that subgroup of patients, we see very similar vision improvement. We saw 1.8 lines of vision gain in our clinical trial, we're seeing about 1.7 lines in that subgroup in the real world. And we see very similar adherence, upwards of 80%, both in the clinical trial and in the real world. So we're really happy with those results. Typically real world results can be a lot messier than what you see in clinical trials, but we're seeing that it's pretty consistent with what we expected and continues to reinforce the efficacy of Luminopia as a treatment for amblyopia.

David Hutton:

You've alluded to this, but could you tell us a little bit more about how Luminopia works?

Scott Xiao:

Absolutely. So from a patient standpoint, it's as simple as choosing your favorite TV show. And you use it for an hour per day, 6 days a week. So they they have to watch TV for that amount of time. And we've partnered with companies like Nickelodeon, Sesame Street, [and] PBS Kids to create this library of more than 3000 hours of content for our patients to choose from and watch during treatment. Now, that's all the patient has to do. The treatment itself is all done through software that we've created. So it's a software application that runs on an off-the-shelf, kid friendly, VR headset. And we present the images slightly differently to each eye. Now going into the mechanism of action a little bit more, it's a dual-acting mechanism. So the first thing that we do is we actually modify the contrast of the images to get the brain to pay attention to the weaker eye. Whereas normally, you would actually see that the weaker eye is suppressed in patients that have amblyopia. So we modify the contrast to overcome that suppression. But on top of that, we have what we call dichoptic masks, which take away parts of the image in both eyes. So when the patient is looking at the video, they're having to fit the puzzle pieces together in order to appreciate the full video. And that's what makes it a binocular approach, a binocular mechanism, and really differentiates it from any of the treatments that have come beforehand.

David Hutton:

Can you tell us about the headsets? Do they just get software or do they have to have their own headset?

Scott Xiao:

It's a great question. So we try to make it as simple as possible for everyone involved. So for the physician, it's as simple as writing a prescription for Luminopia, they can do it through their EHR, through fax. And then our partner pharmacy handles the rest from there. And that includes actually shipping a headset to the family. So the family doesn't have to have their own headset, the only thing they need to have is WiFi. So they receive the headset in the mail, they get an access code from the pharmacy. So they put on the headset, they connect it to WiFi, they put in the code, and they can start treatment.

David Hutton:

And we look at the PUPiL Registry, what's the next step for that?

Scott Xiao:

Yeah, we're excited about the evidence that we're going to continue to generate as the PUPiL Registry gets larger. So at the time of the first data cut, and the first presentations that came out of the registry, we had about 10 sites. Since then we've on boarded 5 or 6 additional sites, and that's only going to continue growing. So we're excited about the sample size continuing to grow. And as that happens, we'll be able to answer additional scientific questions and look at subgroups and even more detail as those subgroups get larger. And so we plan to continue publishing more and more data, more and more interesting findings from that PUPiL Registry over the next couple of years.

David Hutton:

And lastly, what kind of feedback are you getting from physicians who have prescribed this, as to what their patients are seeing as far as results?

Scott Xiao:

Yeah, I would say we've got a lot of physicians that are really excited and grateful to have a new treatment option. A lot of the physicians that we've been working with, have only had patching, atropine, and nothing else since they trained as pediatric ophthalmologist or as optometrists. And to have something else for, whether it's the patients that really struggle with patching. They're not compliant, they don't like wearing the patch. Or maybe it's the patients that have been through patching didn't get the results that they were looking for. Or maybe it's a brand new patient that's just newly diagnosed, we've shown efficacy in all of those different patient types. And we've seen that physicians are really excited to have this new tool in their toolkit to be able to treat these patients.

David Hutton:

And is there any other aspect of this maybe that I haven't asked about today, that would be important to note?

Scott Xiao:

I think for the audience that we're talking to really just the ease of use. So I mentioned this a little bit earlier. A lot of people think about new technology, and they think it's going to be complicated to actually implement and bring to their patients and we've made it a priority to make it as easy as possible. So from a physician standpoint, it's really as easy as writing a prescription for the product, sending it to our partner pharmacy, and we handle the rest from there.