Transcript
Announcer:
Welcome to CE on ReachMD. This activity, titled Real-World Evidence of Photobiomodulation Efficacy in Ocular Indications is provided by Evolve Medical Education.
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Dr. Munk:
Hello, everyone. This is CE on ReachMD, and I’m Marion Munk. And today, I’m joined by my colleague, David Boyer. Thank you for joining us. Today we will review the real-world evidence of photobiomodulation efficacy in ocular indications.
Dr. Boyer:
Well, as you know, PBM has been around for a long time. I mean, it's been used to treat a variety of conditions. This is new, basically, to ophthalmology, but it's not new in other fields. I mean, it's been used to treat diabetes, brain injuries, spinal cord damage, and dermatologic condition. It's noninvasive and reduces inflammation. It has an effect on mitochondria. And I think that there are a number of different therapies out there today that are looking at mitochondrial dysfunction, which occurs very early. It occurs as we all get older, but it occurs much faster in patients with AMD. So I think that these treatments with PBM, if they can improve the mitochondrial dysfunction, will lead to an improvement of vision and stabilization.
There’ve been over 10,000 publications on PBM, and I think that we're getting more information. You're in Europe, and the EUROLIGHT registry is ongoing. Can you describe that? Because I think that's going to give us really important data due to the size and the length of follow-up.
Dr. Munk:
Yeah. I think, as you have mentioned, real-world evidence is always very, very important because when we look at the clinical trial data, for example, in neovascular AMD, and then we compare it to real-world evidence and data, they usually do not translate in what we see in the clinical practice. So, it's very, very important to see whether these visual function benefits and also these, kind of, secondary benefits we saw in terms of slowing the progression in order to develop advanced dry AMD, is also seen in real-world evidence.
And one large trial, the so-called EUROLIGHT registry, is an ongoing trial which really collects up to 1,000 subjects, which are treated with PBM. And they are collecting best-corrected visual acuity—or we are collecting—and OCTs for this period of 4 years, in order to see how PBM does in the real-world setting. And so far, we have collected over 100 patients and there will be over 20 centers in Europe and, potentially, also in Latin America and also in the United States.
Dr. Boyer:
This is very exciting because this, as you pointed out, will give us real-world evidence. You have a much broader label in Europe than we have in the United States, so we're limited, basically, to patients with 20/32 vision and drusen, whereas you are able to treat a variety of other conditions. I think there's some talk about treating central serous, there's talk about treating patients to see if you can reduce GA, and you've also had some experience, Marion, in patients who have had wet AMD that you've treated in conjunction with this. And getting a better response, visually. So, can you elaborate a little bit for the audience?
Dr. Munk:
Yes, that’s correct. So, first, what I think is important is that I did a small assessment or examination where I really looked at the visual acuity improvement of our patient cohort we have treated so far, and I think we have treated now over 160 patients in our clinics. And, actually, what is very nice to see that in mean visual function improvement of over 5 letters, we also see this in daily clinic and in real-world. So this is really something we see. But of course, with the variability. And especially, you have mentioned that we have a broader label, so we treat a lot of patients with GA. And especially with patients with GA, the improvement of visual acuity is much more variable. I have patients who’ve gained significantly in vision, and I've patients where no visual acuity benefit was seen, for example, in center-involving GA.
Also, now having implemented this for over 2 years now, of course, we see patients who have neovascular AMD and, for example, already dry. So, their treatment has been stopped, for example, and they are only observed. Or they get only 1 injection maybe once a year because, otherwise, they're completely dry. But, of course, these patients also want to improve their visual function. And so, I also have some experience with these kind of patients where we can see that, even in patients who have been treated with neovascular AMD, now only have, like, dry AMD, but with history of neovascular AMD. And also, these patients show visual function benefits when you treat them.
Of course, so far, we have no data and really no good evidence how, for example, whether it would be possible to combine it. Having, for example, PBM treatment in combination with injections. But I think these will be all questions and research questions, which will be answered over time, having really, prospective large clinical trials.
Dr. Boyer:
I want to thank you very much for your insights, it was very helpful. And it looks like PBM will have a number of smaller studies to try to determine its efficacy in other conditions. And I want to thank you for your insights in that case.
Announcer:
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