GAMBUZZA: Welcome to the Ophthalmology Times Roundup with Dr. Veeral Sheth and Lucia Gambuzza. Good morning. It's Friday, September 18, and this is The OT Roundup. Here's what's ahead on this episode: ESCRS kicked off in London last week and we've seen a lot of data out of this conference. Our first story explores the eye as a window into ADHD, and the other, an in-person interview with Dr. Mfazo Hove discussing his personal experience as a surgeon with diffractive trifocal IOLs in his own eyes and how it impacts his practice. Back in the states, the FDA has accepted Nanoscope Therapeutics' Biologics License Application for MOGENRY, formerly MCO-010. Later in the episode, my cohost Dr. Veeral Sheth joins us to break down what it could mean for retina surgeons. Lastly, the AMA moves to classify myopia as a formal disease in a call for increased public health education. Let's get into it. Regulatory news, trial data, the studies our editorial board is actually talking about. The goal is simple: you should be able to listen on the drive in, during your morning coffee, or between cases, and feel caught up. Every episode also includes Expert Insight from Dr. Veeral Sheth, a retina specialist and a longtime contributor to Ophthalmology Times. He'll join us for an exclusive interview on the FDA acceptance of Nanoscope Therapeutics' BLA on MOGENRY in this episode. Good note to add, everything I mention is linked in the episode description if you decide you would like more information. All right, here's the news. A new review from Polish investigators, presented by Dr. Sylwia Kijewska, an optometrist of the Polish Optometric Association, looked at what's happening in the eyes of people with ADHD, and the findings suggest the eye might actually be a window into what's going on in the brain. They found that in adults with ADHD, OCT imaging showed thinning in the central macula and in some of the retina's inner layers. OCTA added another piece to the puzzle, picking up reduced blood vessel density across the macula and thinning around the optic nerve. So you're seeing both structural and vascular changes in the retina. Kids, however, told a different story. In children being treated with methylphenidate, a common ADHD medication, researchers saw reduced corneal endothelial cell density and changes in cell shape. Interestingly, their retinas looked fine. So the concern in kids seems to be more about the front of the eye than the back, which is a distinction worth flagging for anyone monitoring pediatric patients on stimulant therapy. There's also a behavioral angle here. A portable eye-tracking tool combined with machine learning was able to classify ADHD in children with over 90% accuracy. And separately, wearable devices called neuro glasses showed some promise improving attention and executive function in adults, with no major issues with eye tolerability. So what does this mean for the clinic? The researchers aren't saying we're ready to diagnose ADHD with an eye exam. In fact, Dr. Kijewska was pretty direct about that, saying standalone ocular diagnosis is still, in her words, the stuff of science fiction. But they are making the case that retinal imaging and eye tracking could become useful supporting tools in a broader, multidisciplinary approach to ADHD care. It's an early but genuinely interesting look at how the eye might reflect what's happening in the brain. Check out the full article by our producer Lynda Charters in the description. Now for something a little different. At ESCRS in London, our producer Martin Harp interviewed Dr. Mfazo Hove, a consultant ophthalmologist who brings a pretty unique perspective to trifocal lens surgery. He's not just implanting them, he's actually had them himself for the past two and a half years. Here's the backstory. Dr. Hove has uveitis, an inflammatory condition that's managed with steroids, and those steroids ended up causing cataracts. When it came time for his own surgery, he chose the same lens he'd already been using on his patients for years, the AT LISA tri. And the results? He says the vision quality surpassed anything he was expecting. Glare and halos, which are a common concern with trifocal lenses, disappeared for him after just two or three days. That experience changed how he counsels patients. He's upfront that glare and halos are part of the trade off, but he can now speak to that from personal experience rather than just what he's read in a study. He even shared one practical tip he picked up along the way: right after surgery, he sets his patients' phones to the smallest text size, which he says helps their eyes adjust to reading small text much faster. Maybe the most interesting part of the conversation, though, was Dr. Hove's take on why this matters. He made the case that ophthalmologists should be willing to have the same technology they're recommending to patients. As he put it, if you don't personally believe in a lens enough to have it in your own eyes, that's worth asking yourself why you're giving it to someone else. Watch the full interview with Dr. Hove, linked in the description. There's a big development in retinitis pigmentosa. The FDA has accepted the biologics license application for MOGENRY, or MCO-010, from Nanoscope Therapeutics. This is notable because right now there's no approved treatment in the US for advanced RP with severe vision loss. What makes this therapy different is that it's gene-agnostic. Instead of correcting one specific mutation, it uses optogenetic technology to give surviving retinal cells the ability to sense light, regardless of what's causing the disease. The filing is based on the RESTORE trial, where treated patients showed meaningful gains in visual acuity that held up over time. We got some perspective on this in a Q&A with Dr. Benjamin Bakall, a retina specialist in Phoenix, who called the approach genuinely gene-agnostic and said it brings hope for patients who've had very few options. To dig into this further, let's call up Dr. Veeral Sheth, my co-host and retina specialist at University Retina.

SHETH: Specialists and ophthalmologists that see these patients that have retinitis pigmentosa, we all know that really there hasn't been anything for these patients. Right. So you've got this kind of multifactorial disease of retinitis pigmentosa, more than 80 genes, 1 in 4,000 of our patients. So it doesn't sound like a lot of our patients, but we see these patients quite often in our clinics. And the frustrating thing is we tell them the same thing, which is, hey, you've got retinitis pigmentosa, and there's not a lot we can do at this moment. And then we try to give them some hope and say, hey, there are, you know, smart people working on potential treatment options, and hope is on the way. And that's really kind of the gist of the conversation for these patients.

GAMBUZZA: You run one of the larger retinal trial programs in the country. How strong is the RESTORE evidence, and what will the FDA be weighing?

SHETH: Yeah, so, you know, the RESTORE trial was really looking at, you know, these retinitis pigmentosa patients. And, you know, it's different than what we saw with Luxturna. Right, Luxturna, we know we've had for years now. But Luxturna was very targeted to one gene defect. Right, this is different. Now we're talking about a potential treatment option that can work. That's really kind of mutation-agnostic, right? So this is anybody that has advanced retinitis pigmentosa could potentially be a candidate for this treatment. And that's really the way the RESTORE trial approached the study. And so people will say there's a small trial. Yes, there was 27 patients. But remember, this is an orphan disease, right? And so even with Luxturna, in that trial there was 31 patients. Right, so there's a precedent to have these small studies to get these treatments approved. And then, you know, what do they look at? They looked at a high-dose version of the treatment, a low-dose version of the treatment, and then a sham group, right? And I think that's really, really important here, because you want to be able to compare it to what is happening to these patients that aren't treated. And so what do they find? They found that in the treated groups, roughly half of those treated eyes gained three lines. And when they follow these patients out, that gain is persistent. I think one thing you've got to point out is these patients start with pretty low vision, right? These were hand-motions, counting-fingers patients, like many of our advanced retinitis pigmentosa patients. But they were able to gain three lines, right? So that's the difference between, you know, barely being able to see things moving in front of you, the difference between light and dark, to now being able to see the plate in front of you at dinner, or, you know, you're crossing the street and you can see a car kind of coming across the way. So that is really meaningful impact for our patients who have that advanced RP.

GAMBUZZA: Of course, those findings, those three-line vision gains, can be life-changing for the patient. If this therapy is approved, what will immediately change in your clinic, and what are you watching for?

SHETH: Yeah, so I think, you know, anything we look at these days, you know, we've got a lot of treatment options. We've got systemic treatments, we've got local treatments, including, you know, surgically delivered intravitreal injection, suprachoroidal, topical, you name it. So, but in the last 20 years, I would say as a retina specialist, we've gotten really good at these in-office intravitreal injections. And that's how this treatment is delivered. And it's so different than other treatments that have been looked at in this space. Like, you can look at the Argus, for example, which was a device you had to implant. Or there are certain treatments where you have to wear goggles. In addition, this is a pretty simple, elegant kind of treatment approach, which is, hey, we're going to do a one-time, in-office intravitreal injection. There's no vitrectomy, there's nothing like that. And so the ease is there, in terms of it's something we know how to do already. So that barrier is lowered. You don't necessarily have to do genetic testing on these patients to determine whether they're a good treatment candidate. That being said, we're probably still doing genetic testing, because it helps us drive prognosis and family counseling and all of those things, and potentially eligibility for future gene-specific treatments. So that's still an important part of it. But it doesn't eliminate patients like some of the other treatment options that might exist, or that are being looked at today. And so, as of now, though, you know, we're looking at these really advanced patients. In other words, patients that are hand-motions or counting-fingers. That's what was looked at in the trials. But the question is, will this have an impact for maybe our better-seeing patients? So a three-line improvement in a hand-motions patient is meaningful. But if you think about a 20/160 to 20/70 patient that maybe isn't able to drive, and you can improve them a little more to driving vision again, now we're taking bigger steps forward in that sense. So we'll see kind of how it plays out in those patients. But at the end of the day, this is a big step forward if it ends up panning out.

GAMBUZZA: One more question I have: in this interim period, where this is not FDA-approved but there is a BLA accepted by the FDA, do you communicate to your patients that this may be coming soon?

SHETH: I do, because, you know, we work with a lot of clinical trials, and when trials get to the later stages, and we get to the BLA stage, and we know the FDA is reviewing data, I do start to talk to patients about it. I won't necessarily talk to them about phase one, phase two, because we know those don't always pan out. But when we get to the later stages, we do start talking about it, again, one, to kind of gauge interest, but the other is to make sure that they have hope, that they know that there are smart people working on these things, and hopefully one day there will be a treatment option for them. And I think that drives compliance. And again, you know, I think that's important for patients to know what's going on and what's potentially on the horizon.

GAMBUZZA: Thank you very much, Dr. Sheth.

SHETH: My pleasure. Thanks for having me, Lucia.

GAMBUZZA: As this story continues to develop, keep an eye out for more data. Nanoscope is set to present 4-year results from the MOGENRY retinitis pigmentosa program at the Retina Society's 59th Annual Scientific Meeting, happening September 23rd through 26th in Los Angeles. We'll be watching closely, but for now read all our coverage by our producer Kassi Filkins, linked in the description. Last story for today, and this one's a big-picture policy shift. The American Medical Association has passed a resolution supporting formal classification of myopia as a disease, including by the Centers for Medicare and Medicaid Services. The goal here is to open the door to insurance coverage for myopia treatments in kids and teens. This actually lines up with something the American Academy of Ophthalmology has been pushing since 2021, when it launched a global initiative to delay myopia onset and slow progression in children. And the numbers behind this are pretty striking. Myopia now affects about 41.6% of the US population, nearly double what it was 50 years ago. Globally, the World Health Organization projects that half the world's population will be myopic by 2050, and up to one-fifth of those individuals will face a higher risk of blindness from complications. High myopia raises the risk of retinal detachment, glaucoma, cataracts, and myopic maculopathy, all of which can cause permanent vision loss. So what actually helps slow this down? A few options are already out there: Stellest eyeglasses, multifocal soft contact lenses, orthokeratology, and low-dose atropine drops, though that last one has stronger evidence in East Asian populations than in Western ones so far. Even something as simple as two hours of outdoor time a day has shown some benefit. The bigger issue the Academy is pointing to is awareness. Dr. Rupa Wong, a pediatric ophthalmologist, put it simply: most parents are never told these treatments exist. And as she said, kids' eye health is a public health issue, not a parenting one.