Theialife’s race to bring a childhood myopia treatment to market

0:05Thomas Ruggia: Hello, and welcome to Beyond Biotech, the weekly podcast from La Biotech. I'm Dylan Kassane, and this is episode 216 for the podcast. By 2050, nearly half of the world's population is expected to be myopic, with around a billion people projected to progress to high myopia, a leading cause of irreversible vision loss later in life. Children face a narrow window in which to intervene while the eye is still growing before those structural changes become permanent. Yet despite the scale of the problem there is still no FDA approved drug that slows myopia progression in children a gap underscored just last month when the FDA declined to approve an atropine eye drop for the same use.

0:53Thomas Ruggia: My guest today is Thomas Ruggier, President and CEO of Thailife, a late-stage biotech developing an oral therapy for pediatric myopia derived from a natural caffeine metabolite. Tom joins Thailife after 25 years in ophthalmology leadership, including roles at Johnson & Johnson, Alcon, Novartis, and most recently as CEO of Samsara Vision. We talk mechanism, evidence, and the road to phase 3. I hope you enjoy my interview with Thomas Rogier. Tom, welcome to Beyond Biotech. Hello, thanks for having me. I really appreciate your time. Tom, you've had a career now, 25 years across some big pharma, most recently as a CEO of Samsara Vision.

1:40Thomas Ruggia: Now you're at a late stage clinical biotech and you've left that commercial stage device company world. What made you want to take that leap? Yeah, I think this is the most important innovation of recent years in ophthalmology. We're going to get into today pediatric progressive myopia, which is what we're trying to tackle at Theolife. And the opportunity came to me, and it's a once-in-a-lifetime opportunity. And you just can't say no to something like that. Although I've loved my time, 26 years in ophthalmology, 15 years with Alcon, five years with Johnson & Johnson. most recent six years with Samsara Vision as CEO in medical device ophthalmology.

2:25Here, though, this biotech company has, I think, a real big promise with a delivery mechanism that's ideal for children and a mechanism of action that's going to change the trajectory of high myopia. And we're going to get into all the definitions of what myopia is. But really, my rationale for joining Theolife is really the size of the prize here is the biggest, maybe in the history of eye care.

2:57Thomas Ruggia: Samsara, you were working on macular degeneration for older adults. Your company now is at the other end of the age spectrum, working with children whose eyes are still developing. Is there anything that crosses over between those two worlds? Yeah, less in the patient, maybe more in the business. The eye care business, although we talk about pharmaceutical, consumer med tech, and surgical medical technology as different things. And in some industries, they truly are. In ophthalmology, a lot of the base connective tissue is there. So the customers, whether that be cornea specialists, pediatric ophthalmologists, optometrists, these are people who engage with pharmaceutical products, medical technology, surgical technology.

3:52So many of them are the same. The eye as an organ is a complex organ in terms of what it does to bend and refract light, to make images meaningful to the brain to navigate your world. That's a very complex thing. But the organ itself, with all of the different physiological parameters, it's the same. So in my career, I've been in glaucoma, pharmaceutical, I've been in surgical cataract, big equipment, I've been in refractive lasers, I've been in recently, and like you said, in telescopic implants for macular degeneration. My career has spanned the globe. So although I live in the United States, most of my career has happened outside the US with ophthalmologists and the healthcare ecosystem.

4:45So I think the connective tissue between the customers, the regulatory environment, the regulators, the payers, how the business is done is very similar, even between all of those things. So yeah, I think that's why it all works.

5:02Thomas Ruggia: You know, if we dive into pediatric myopia, this is now being talked about as a global health problem rather than just, hey, kids need glasses. Tell me a little bit about that. What does the disease entail? Yeah, and as I learn more, you know, like you said, you know, this is new to me. For the last six months, I've really been over-indexing on consuming all the content I can possibly consume on this area. And, you know, the takeaway for me is that the pediatric nature of the treatment is where the disease begins and where the the and we'll get into how the disease takes shape. But but this is a condition what we're all trying to do between the devices and the other pharmaceuticals that are trying to come to market.

5:46What we're all trying to do is to prevent high myopia and high myopia is defined. You know, some people define it as greater than a minus five myope. Some people define it as greater than minus six. But the layperson would know this as the people in your life that wear very thick glasses. We used to refer to them as Coke bottle glasses back in the Stone Ages when I was young. And that patient who has progressed to that point is at risk for early cataracts, more than a 20 % increase in risk for early cataract formation. And then retina detachment, due to the nature of the disease, retina detachment is very common.

6:27And specific kinds of maculopathy or diseases of the back of the eye are found in patients with high myopia. So pediatric progressive myopia makes people in the industry, investors and, you know, everybody just glancing at this, think about children and chalkboards and glasses. But that's really not what we're doing here. So the disease takes shape, begins around the age of four or five. And a pediatrician might notice that one of the patients in an annual exam has some difficulty seeing, you know, an eye chart. And all patients at a very young age are what's called hyperopic or farsighted. We've all heard of farsighted and nearsightedness.

7:12Myopia is just another word for nearsightedness. So everyone is born farsighted. And that's because the eye is short. And as you grow and develop, the eye grows longer. So some people, the eye continues to grow beyond where it should stop. And that's progressive myopia. So as the eye elongates, the cornea takes a steeper dome shape and that bends light, you know, a little bit too much. And then the patient gets what's called nearsightedness or aggressive nearsightedness. But if a four-year-old has any nearsightedness, that's a warning sign that this is a progressive disease that could end in minus five or minus six severe Coke bottle glasses, you know, high myopia over time.

7:59So we want to intervene at that age, 5, 6, around there, and we want to stop the eye from elongating any further than it should. And if we can stop that effectively and keep the patient under minus 5, that will lead the patient to a life that is far easier to live in terms of concomitant disease that they will expect if they go to high myopia. So misnomer, it's not about kids and chalkboards and glasses at an early age. This is about preventing irrational elongation of the eye so that we don't see high myopia in these patients. And high myopia is actually the epidemic. So, yes, 50 % of the world's population will be myopic by 2050.

8:50That's a stat that we all talk about. But more than 10 % of those patients will be progressive and convert to high myopia. And that's where the real risk is. Today, 12 million children in the United States, age 6 to, let's say, 15, they are in the risk and they can be treated if our therapy was on the market today. And then that number is doubling by 2050. And we think that's doubling because lifestyle. So the lifestyle of the 1950s had people outside. Children were outside all the time. They were exposed to different wavelengths of sunlight in the morning and the afternoon. They were distance tasking at a distance.

9:34Like if you look at a tree, you know, some parts of the tree are closer. Some parts of the tree are further. There's shadowing. There's light. And the eye recognizes that in the retina and signals to the sclera to stop the increase of elongation. But when children do tasking with backlit blue light devices that are near, the eye doesn't stop growing. And then the 2050 lifestyle, quote unquote, is more of an indoor backlit device, close tasking. And so the eye is confused. And that's driving the epidemic.

10:08Thomas Ruggia: That's incredibly interesting to me because this is something where you talk about an epidemic of this high myopia. But even just myopia itself, half the world by 2050? That's an incredible statistic. Yep, half the world, a lot. And I mean, we're seeing, we're talking about 50 % of US patients up to. So today we're at about 36 % based on latest epidemiology data that I've seen. That's forecast to grow to 50 % over time in the United States. It's an amalgamated population. When we talk about Asia Pacific, they're talking about eight in 10 people going to be myopia by that year. There's a lot of reasons that are speculative for that.

10:50But whatever the reason is, this is a growing part of it. And we're seeing governments recognize it as a public health crisis. The government of Singapore, China already recognizes it. Then we have Korea recognizes it as an epidemic. And then in the United States, the American Medical Association just recognized myopia as a disease, not just a refractive condition. These are huge moves.

11:18Thomas Ruggia: Tell me a little bit about the therapy then, because you're talking about children and this is preventative. If we can solve it for the child, then we hope that it won't turn into something worse later. What changes structurally in the eye once a child stops growing? And why can't you undo those changes in some other way? Well, that's a good question. Yeah. So the disease we're talking about here, the child stops growing, but the eye has grown longer. So if you imagine the eye back to front, and that's elongating as the child grows, once that has stopped growing, you can't make the eye shorter.

11:57So it is what it is. It's almost like a femur. Once a femur reaches a certain length, you can't send the femur back. You know, maybe we can do, if the femur's not growing, You know, there's all kinds of growth hormone, you know, elicitors that can help with making the femur grow marginally bigger. But once the femur reaches its destined length, you know, you can't make the femur shorter. So that's the same thing here we're talking about. So the eye grows and the retina signals to the various structures of the eye to either continue to grow or stop growing based on what the retina is seeing. So the retina is the back of the eye.

12:39The cornea is the front of the eye. The retina has photoreceptors that receive light and understand it's brain tissue, it's their neurons. And it tells the other structures of the eye, you know, where they should start and stop and how collagen should be deposited in the sclera. So if the retina is not outside, if the child is not outside in sunlight doing distance tasking in sunlight, the retina doesn't say, hey, you got to stop. It doesn't recognize backlit blue light devices at near distance as trees and birds and things that are in the distance. So the eye keeps growing. And we can't make that eye go back.

13:24So the interventions that we have to use have to play a role in pediatrics. And we have to do early recognition at the pediatrician. We have to engage treaters. So the treaters will be myopia-focused optometrists as well as pediatric ophthalmologists in getting people onto therapy early. And then today, there are a number of therapies that are either on market or coming to market, one of which we have devices and contact lenses. We have overnight contact lenses called orthokeratology. We have spectacle lenses, the Stellis by Essilor. These are all bending light differently, letting certain wavelengths in and out, and bending the cornea in the case of ortho-K.

14:14So they each have their own way to do it, mostly around refraction and then therapeutic refraction. And then we have low-dose atropine, which is an older technology for glaucoma and for cycloplegia. But now we're seeing a different use at low dose to adjust the thickness of the choroid. The choroid is the blood supply for the eye, and it's a tissue plane that sits slightly anterior to the sclera and to the retina. And, you know, so that's where atropine acts. Our therapy is a bit different. Our therapy acts on dopamine and adenosine, down-regulates adenosine, up-regulating dopamine and allowing the retina to signal appropriately to the sclera to enhance the collagen deposition in the sclera during the formative years.

15:13So our therapy, we feel, we have to go through a phase three trial. We're in the beginnings. We're meeting with the FDA at the end of September. But once we are in phase three, we think our mechanism of action is preferable because it addresses the structural integrity of the sclera during formation and will stop the elongation of the eye, even in an environment where the patient is not running around outdoors. So we think that's a good mechanism of action.

15:43Thomas Ruggia: this asset of yours your lead candidate that's nd10 uh it's derived we read from a natural caffeine metabolite uh you're putting caffeine in the eye right what's actually going on here yeah not quite but kind of and it was one of the reasons why i made the jump uh and because look safety of a new chemical entity is always a question mark and always something but but here we take the most widely used drug in the world, caffeine. I mean, it's ubiquitous on all corners of the earth. You know, it made the Marco Polo's trade routes like this is not a new chemical entity. Caffeine is not. But ND10 and 7-methylxanthine is the second, is a second metabolite of caffeine.

16:27So if you imagine the coffee that you drink in the morning or the tea that you have in the morning or the Celsius or Red Bull or whatever it is, however you take in caffeine, let's say you take in 100 milligrams of caffeine, about 10 milligrams is 7-methylxanthine excreted. So this is a 10 % metabolite excreted in the body. But when we refine 7-methylxanthine in a proprietary way, and we deliver it orally at 100%, so not the 10 % of caffeine. The difference between 7-methyloxanthine and natural caffeine is that 7-MX does not cross the brain barrier. So we have the dopamine effect of 7-MX, not of caffeine, but of 7-MX, without the stimulant.

17:16So there's no uptick in heart rate, there's no increased blood pressure, There's no interference in ADHD or any of this. And we've used this. Our founder, Klaus Treyer, he's an ophthalmologist, has now treated 1 ,200 children in Denmark. And we've seen no adverse events related to this higher dose, which is in phase three, we're going to go with 1 ,200 milligrams daily of 7-methylxanthine taken orally in a capsule that can be opened and put on food. But yeah, it's a grandchild of caffeine, but it does not have the same stimulant effects as caffeine.

17:57Thomas Ruggia: Now, I've seen it described as going after the root cause of myopia and not just the symptoms. Maybe tell me two things here. What is this root cause? Is it just that development and just looking at the screens in part? And why have other approaches always gone after the symptoms? Is it just because we didn't understand that mechanism? I think the mechanism is just more recently being better understood. And, you know, what's at risk? There's some degree of genetic, obviously, with 8 and 10 people in Asia developing. So we have some degree of genetic predisposition. We also have subcategories of myopia developing where we see strong genetic links.

18:38But those are subcategories with less than 10 % of total myopia population. But basically what we're talking about here as a root cause is the lifestyle differences between a 1950s person and a 2050s person, that indoor lifestyle, that backlit device, that near casking versus distance tasking. And that leads to an irrational elongation of the eye during development. So what we're saying is that we address the collagen deposition in the sclera by down-regulating adenosine, up-regulating dopamine, which signals the sclera to deposit collagen more effectively. And that collagen deposition stops the eye from elongating by setting a strong foundation at the sclera.

19:30Thomas Ruggia: You mentioned just a second ago this use in Denmark by your founder. It's more than 1 ,200 children a year. And you said over 20 years? This is an incredibly long period. How do you weigh that sort of long-term, real-world use against a randomized trial? Or how would a regulator weigh that? Yeah, we're engaged with the FDA now. We've submitted all of our data. So we had two trials that we consider phase two. The first was a 77-patient trial that gave us the compassionate use in Denmark, thanks to the Danish Medicines Association for recognizing this in 2006. And that led to, that was that 400 milligrams immediate release tablet dosed once per day, and we saw an effect.

20:20So from there, we started or Klaus started to increase the dose and change the dose and see how the effect worked. He then met via Brian Holden Vision Institute and Brian Holden himself. He met Sandeep Arora, who's an entrepreneur, CEO and founder of Indian pharmaceutical companies in India. So Sandeep and Klaus developed the concept to take the 7-methylxanthine from where it was with Klaus to a mass-produced global winner. And they began that, you know, 2012 or something. So the trials that we have submitted, the 77-patient trial with 400 milligram immediate release tablet dosed once per day, that was the signal of effect.

21:09Then we went to 800 and 1 ,200 milligrams, and we published in the British Journal of Ophthalmology 711 patients. When we look at a subgroup of those patients, we see 265 patients aged 6 to 10 years old, which is a true sweet spot, with the 1 ,000 milligrams or more of immediate release 7-methylxanthine, and they had the strongest effect. So 1.9 diopters less myopia progression over time as a signal. These are not randomized control trial, but it's a large sample size. So we've submitted that along with all of the clinical data to FDA with our rationale, and we meet with them on September 29th to discuss our Phase III program.

22:01The Phase III program will be a randomized control clinical trial, Well, two to one active to control group, more than 400 patients treated with the endpoints that FDA is looking for in terms of myopia progression, responder rate, and all of the things that we're going to measure. So, yeah, I think the data speaks for itself. We've also formulated now for the capsules, so no longer a tablet, but a capsule that can be opened and put on food. and it would be two capsules in the morning, two capsules in the afternoon, each dose 600 milligrams of extended release. So now we've changed the release PK.

22:45So now we have an extended release capsule versus an immediate release tablet.

22:52Thomas Ruggia: Well, this capsule, is that something that people are going to have to take forever or is it only during that stage of development while they're a child? Yeah, I think it would be at child, parent, and payer's discretion. But if we begin treatment at the age of, let's say, five or six years old, that patient should remain on therapy until their adolescent years, so once their growth has stopped. So somewhere in that 14, 15 years of age is really what we're talking about. So anywhere between five and ten years of use of 7-methylzandine. That's why I think it's critical to formulate this as an oral, to formulate this as a capsule, because children taking pills isn't the easiest thing in the world to do.

23:39So we formulated this as the most parent optimal route of administration with the best structural mechanism of action. So we believe that over time, this NB10 therapy will be the first line therapy for patients at risk.

23:58Thomas Ruggia: And is it something that will also preclude the need to wear glasses, wear contact lenses? Is that the goal, that these other sort of symptom treating will either be later, much later on, instead of so much earlier? Yeah, I don't think that's the goal. The goal for us is to keep as many patients under five diopters of myopia. So if we have a patient or a child that at four years old has a half a diopter of myopia, we want to keep that patient under five. And that's the goal. So, yes, they're going to need spectacles. They have a disease that recognized disease by the American Medical Association.

24:37They have a disease that's going to lead to significant lifelong, not just the spectacle wearing, but and the quality of life, which is really challenging for patients with thick prescriptions. But the early cataract formation can be very, very detrimental, costly. The retina detachment can happen multiple times and happen in the 40s and 30s, not in the 60s and 70s. So these risks associated, there's a normal tension glaucoma that's specific to high myopia. So these are the things that we're trying to prevent. I think where it gets super interesting is treating a pediatric patient between 5 and 15 years old stops a condition that costs payers$150 ,000 is the number that is different between a minus 5 myope and a non-minus 5 myope.

25:34So we're going to save payers$150 ,000 on average, but that's not going to come until the patient is an adult. And so, you know, I think we're going to have to do the real hard work, you know, along with industry, you know, other therapies to convince payers that it's worth the investment in pediatric years to prevent the sequelae that happened much later in life. So that's a really interesting part of this. And the first step is recognizing myopia as a disease, which recently the American Medical Association has done. That opens the door for practitioners to petition and to get payers to recognize the diagnostic techniques that are necessary and pay for those.

26:16And then eventually, the therapies that are coming to market need to be reimbursed. So what an exciting time for patients that are at risk.

26:25Thomas Ruggia: you know there is it's recognized as a disease there's a huge unmet need in the u.s and elsewhere around the world but there's still no fda approved pharmacologic therapy for pediatric myopia why do you think it's been so hard to get something across the line when really that need is acknowledged yeah isaac newton talked about inertia so many years ago right i think that's part of this You have a market today that between my site contact lenses from Cooper Vision, the Stellis lenses, spectacle lenses from Essilor and the low-dose atropine is now done in compounding pharmacies. So there's a business there with low-dose atropine.

27:08So we have a patient pain market with a number of therapies and orthokeratology too is in there. Johnson & Johnson is part of that as well. So you have a number of therapies for a group of about 3 ,000 treaters, maybe a little bit more than 3 ,000 treaters, where they have a patient pay business. And some of the diagnostics are all diagnostic tests and work is also patient pay. So you have an outside of system industry that is set up. You know, for us, it's it's jump making the jump for me. I wouldn't say us for me personally. I want to see a jump made from the the private pay market to the payer market.

27:49You know, I think because that once you do that, the access to care broadens out from the affluent to, you know, to every person in the United States. And, you know, hopefully other payers, government payers outside the U.S. follow suit on that. You know, we'll petition as many governments as we can. to recognize this therapy as lucrative. I think that we couple that with other pediatric diseases. One that comes to mind for me is keratoconus. And these are very similar conditions in the sense that keratoconus is a very, very steep cornea. And that happens because cross-linking doesn't happen. There's some similarities in the mechanism.

28:31There are some similarities in the age grouping. Keratoconus maybe manifests a few years later, maybe 10 years later, but still a pediatric beginning to that disease in many cases. And that's recognized as a disease. Now we see two very important treatments for keratoconus coming to market. Epioxa from Glaucos and Epion's EpiSmart is coming to market as well over time. And we see payers willing to pay and, you know, to treat that condition and to arrest that condition and to prevent the elongation of the cornea or steepening of the cornea, you know, payers will pay$78 ,000. We just saw that, that, you know, that happened from glaucosin and good for them.

29:19But that's a one-time treatment. So people are talking about, oh, my gosh, a one-time treatment,$78 ,000. If we think about that differently and we sort of transfix that or we move that, we amortize that dollar amount over that period, maybe five to 10 years, yes, all of a sudden it's not so much money. And so payers are preventing the sequelae that happened for a keratoconus patient later in life by the upfront investment of quote unquote$78 ,000. And I think that is what the myopia world needs to look at as a benchmark. And, you know, we're not going to say, you know, every month somebody's got to pay$78 ,000.

29:56But if I look at the treatment of a patient, what's that worth? You know,$78 ,000 investment to prevent$160 ,000 in, you know, an average sequelae. You know, that to me sounds like a good investment.

30:12Thomas Ruggia: You know, there's that old showbiz maxim of never wanting to work with children or animals. It's just hard. You're trying to develop a phase three trial here. that really is focused on children. What makes it hard to design a trial for children like that? You know, probably the dropout rate. So we're talking about dropout rates anywhere from 15 % to 25%. You know, so that's going to be a challenge. For us, it's not as bad. Some of these patients, some of these practitioners have done clinical trials with eye drops and contact lenses. That's really tough. So, you know, I give them all the credit in the world for doing those.

30:52The eye drops, the low-dose atropine, that's dosed in the evening. Maybe a little bit easier than in the morning. But still, an eye drop in a child, and it's kind of known for stinging. That's fine. It's a treatment that works. So, you know, it's worth the little bit of sting. But for a child, you know, and a parent, you know, that's not easy. So the compliance issue, you know, is tough. But here we have a, we're bringing a capsule that can be opened and put on food. It is the smallest barrier to entry that I think people have tried so far. So I think that will be welcomed by the clinical sites that we'll engage with.

31:29I think we'll likely have clinical trial sites that are familiar with the disease, familiar with the patients. So, you know, that might not be that bad. And we're looking, we've got a host of CROs that we're currently looking at their proposals now as part of the request for proposal process. And we're going to go with somebody that has experience in myopia trials, whether that be device or pharmaceuticals. So hopefully we're mitigating all of that risk that comes with doing a trial for pediatric patients. But I also, I've done trials with elderly patients too, and that has its own set of challenges.

32:07So, you know, I think just each trial is just uniquely different.

32:12Thomas Ruggia: You know, you've spent your career now working on all different parts of the ophthalmology business, financing, launches, reimbursement as well. You know, what's the hardest problem that you're facing right now with your particular asset? That's a good question. You know, this is a new, this is a virgining subsegment of our industry that I believe, and I mean the numbers support, that this will be the largest economic and number of patients market, sub-market in the ophthalmology industry over time. And I think that the challenge there is getting the therapies that work to market, convincing the industry, including investors, that what we're saying and what we're forecasting is going to become a reality.

33:11and then getting the whole universe of ophthalmic diagnostic devices, disease, I guess, like the American Academy of Ophthalmology has to recognize myopia and the steps in the care of myopia and ordain those so that practitioners can go out and do the diagnostics and bill for them and get paid. Same has to be true for the American Academy of Optometry. And they have to ordain the steps and allow for optometrists to bill and be reimbursed for the care. So the ecosystem is not quite in place yet. That's the biggest challenge for not just for Theolife, but also for the other companies in the space.

33:59And there's some companies that are going to be happy with the 3 ,000 prescribers today and the patient pay nature of the sub-industry. But I don't think that's a good long-term structure. I think it has to be widespread. Access has to be near 100%. Payers have to recognize it. And the care has to be paid for. And that's the biggest challenge. We've seen that with things like meibomian gland disease that started out as a patient pay market, small subset of practitioners that were doing device-based in-office procedures. And, you know, with the advent, with the coming to market of Meibo from Bausch & Lomb, originally a German company, that's changed the game.

34:52And that game change, getting payers to pay and having an easy route of administration with a drug allows that now to be prescribed by more than 10 ,000 prescribers annually. So to widen the hoop from 1 ,000 to 10 ,000 is what we did in my bomine gland disease. I think we want to do the same here. So we've got 3 ,000 people treating myopia today. hey, my goal, by the time I retire, I'd like to see that number somewhere in the 10 ,000 to 15 ,000 unique prescribers in the US alone. And worldwide, I mean, that number should be double. 20 ,000, 30 ,000 people should be engaging in the care of myopes.

35:33Thomas Ruggia: You know, when I get to the end of these interviews each week, I like to ask where you see yourself, where you see the company five years from now. Maybe you can tell me that, but tell me as well, What would a child who's got myopia, what's their life going to be like five years from now if you get this sort of therapy approved? Let's say we are approved today, which I wish, but it's not the case. What I'd like to see, I'd like to see the company in its rightful spot with ND10 having a wonderful commercial name that everybody can remember. you know how drugs in the U.S. go, and then, you know, have that on the tip of the tongue of every prescriber in the United States.

36:16I'd like to know that pediatricians, not eye care folks, but pediatricians are aware of the disease and are intervening early. So for children, I'd like to see, you know, four-year-olds having meaningful conversations with their parents and their pediatricians about myopia. And then for the vision screening, not just to be a last thing we do in an annual pediatric exam, but for it to be a real thing for pediatricians. Then I know that we've done our job. And then you'd like to see the underdiagnosed population go from the 95 % it is today down to 5%. We'd like to see everybody get access to care.

37:01I'd like to see payers recognize this. For the business sake, you'd like to see a fair price for the research that we've done. But as long as payers are recognizing the disease and recognizing therapies and paying for therapy so that we don't see patients around the world have to prioritize air for this for a child versus other things in their life, we don't want to see that. So if all that comes to fruition, I'd like to see Theolife and ND10 as the first-line therapy for myopia within five years of its commercialization. And I'd like to see patients highly aware of the disease and getting access to treatment as fast as possible.

37:51Thomas Ruggia: Is there anything else coming up in Theolife's pipeline for ocular disease beyond myopia? Very exciting. Yeah, this is very exciting too. And so we focus today on the biggest swing for the fences that we have at Theolife. But interestingly, 7-methyloxanthine and its effect on collagen and that crosses over to fibrotic diseases of the eye. And we're developing a biomedically engineered technology that has 7-methylxanthine as a foundation, but is not simply another indication for the oral. So we're looking at topical routes of administration and injectable routes of administration for diseases that involve fibrosis and hypoxia, like retina fibrosis.

38:43So today, wet AMD is treated by anti-VEGFs. You know, everybody that has neovascular macular degeneration, you know, goes for monthly or eight weekly or 12 weekly injections to control neovascularization. But when neovascularization happens and we see leaky blood vessels, we get a thing called a discoform scar and fibrosis in the back of the eye. So we want to try to have a, we want to see if 7-methylxanthine is effective in preventing and reversing the fibrosis that happens during AMD. You know, that's one possible indication. And then meibomian gland disease, we mentioned that earlier. Today it's being treated by Meibo, and that's for people that have meibomian gland dysfunction.

39:34But dysfunction leads to fibrosis. and fibrotic patients are out of the treatment realm. And so we would like to see if 7-methyloxanthine can reverse that fibrosis and bring patients back, those glands back, or at least have a dramatic effect in the later stage patients with mepomine gland disease. That would be a topical. And then we've just published, I'm presenting at the American Academy of Ophthalmology, we presented at Arvo on corneal fibrosis and then 7-methylxanthine on corneal fibrosis. So, you know, that's three indications that I feel, you know, can be winners. Not indications for ND10, but new technologies, unique new technologies based on antifibrosis.

40:21You know, and then we're talking about things like injectables during cataract surgery. So an intracameral injection during cataract surgery to prevent fibrosis of the capsule or posterior capsule opacification, which happens in about 30 % of all cataract cases today. So a drug like that could be game-changing for patients that get, quote-unquote, secondary cataract, which is simply a formation of cells at the back of the capsule that fibrous. And so, yeah, I think the future is bright for Theolife because we've got a novel technology that can be looked at as a new class of drug that fights fibrosis versus looking at 7-methyloxanthine as a one chemical entity fighting one disorder.

41:11We have a number of conditions that involve fibrosis today, and we're targeting those. So I think Theolife, I look at it as a clinical and commercial accelerator company, and we have a Theolife limited company in India that is a shared joint venture that is the R &D hub. And that R &D hub is a low cost sort of seed development. And then we push assets from the R &D hub into the clinical commercial accelerator. And that's the Alive Inc. And that's what we have here. So we are going to look for these, we're going to develop these unique chemical entities. We're going to shop them to investors and strategics for interest, and then we're going to bring them into Theolife Inc.

41:59appropriately based on where they are in development. I think that's a unique structure, something that's never been done before, you know, and with a few hits, like if we can hit on ND10 plus a few others in the pipeline, we can have one of the biggest, if not the biggest pharmaceutical company in eye care today.

42:18Thomas Ruggia: Where can people learn a little bit more about what you're doing? Where can they find you? well you know if you're in the eye care industry and you can't find me that's a bit odd because i think i know almost everybody around town but but please uh email me thomas.ruggia at theolife.com that'd be happy to take your email uh or you can uh visit us online at www.theolife.com or find us on LinkedIn, Theolife on LinkedIn, a nice page with a growing page. So please, or you can find me on LinkedIn as well. So many ways to catch Theolife. And we'll be at conferences. I'll personally be presenting at the Ophthalmic Futures Forum in Vienna in a few weeks.

43:05I'll be on a panel about myopia there as well. Then we'll be presenting at the Icelerator meeting at the American Academy of Ophthalmology where we'll be present there too. It will be at investor conferences this week, which may predate the publishing of this podcast. But we'll be at a couple of investment bank conferences in New York as well. So, yeah, we're everywhere. Please find us and give us a shout. We'd like to hear your questions.

43:33Thomas Ruggia: Tom, thanks for joining us today on Beyond Biotech. Thank you very much, Tom. Appreciate the time. That's it for this episode. don't forget to check out all the latest news and analysis at labiotech.eu I hope wherever you are in the world you have a great week ahead thanks for listening and I hope you'll join us again next time for another Beyond Biotech