Innovations in ophthalmology and glaucoma, plus a look at the Iantrek Inc. pipeline
In the latest episode of The Ophthalmic Project, Mark Dlugoss speaks with Sean Ianchulev, MD, MPH, of Iantrek Inc., about the company’s latest advancements in glaucoma care.
Mark Dlugoss:
Innovation in ophthalmology has generated numerous advancements over the last 25 years. These innovations not only have helped ophthalmologists preserve vision, but have helped improve the quality of life for many patients. New technologies continue to emerge, making it easier for not only for ophthalmologists, but for optometrists and eye care providers to diagnose and treat eye diseases with ease, efficacy, and with greater outcomes.
Hello, this is Mark Dlugoss, Senior Contributing Editor of Ophthalmology 360, and welcome to The Ophthalmic Project, powered by Ophthalmology 360. In today’s edition of The Ophthalmic Project, we sit down with one such innovator who has been instrumental in many ophthalmic advancements over the years, everything from the research development of Lucentis to the development of robotic surgery.
Joining the Ophthalmic Project to discuss ophthalmic innovation is Dr. Sean Ianchulev. Dr. Ianchulev, welcome to The Ophthalmic Project.
Sean Ianchulev, MD, MPH:
Thank you, Mark, glad to be here.
Mark Dlugoss:
First of all, your career over the last 20+ years has a list of achievements as an academic, a researcher, an ophthalmic surgeon, an inventor, a business executor, and then as an entrepreneur. You’ve been involved with many incredible advances in ophthalmology from the development of Lucentis to micro-interventional robotics. Can you provide some highlights about your career to this point, and what technological development has been the most rewarding for you?
Sean Ianchulev, MD, MPH:
Well, Mark, yeah, it’s kind of interesting. I guess I’m at that age now where I can look back and you can start really worrying that you’re listing too many things or too many years behind yourself, so it is great. I actually more think about the future, I never really ponder about the past and the innovations, let alone thinking about which one’s better or which one I like more. They were all, in many ways, extremely exciting. They were all driven by passion for innovation or making a difference, and many of them fortunately turned out to become actually products and solutions that myself and my colleagues actually use every day. Again, not in 100 patients or 1,000 patients, now in millions of patients.
When I go back many years, the word innovation was very rare. You either come out of medicine and you go and do the clinical practice or you come out of medicine and you become a researcher or you do a combination of both and you do research and development and clinical practice. But innovation was a very divergent word, didn’t really exist, nobody really knew what to do with it. Was it something on the industry side? Was it something on the medical side? On the academic side? I was recently at JP Morgan and there was a nice meeting with Dean Daley and Harvard Medical School and a lot of us who I call divergents, people who are physicians that have done a lot of things outside the straight path of clinical practice and academia. It was great to see how that has evolved over the years.
I think for me, looking back, all these innovations and everything has been just an expression of my own self and probably of my complete lack of ability to say no to things that come my way. Obviously going into vet and med tech is very different than going into biotech and is very different than going into academia, it’s very different than undertaking a digital health project or robotics project. I think people self-select themselves and differentiate themselves just like we have differentiated and cut the eyeball into anterior segment, posterior segment, optic nerve, retina, cornea, oculoplastics. I think that to me is a function of our need to specialize.
But at the same time, the good thing about innovation as we’re seeing develop everywhere is that it’s a little bit agnostic to specialty. You can involve yourself in a biotech project and develop a drug for the eye, or you can develop a device or intraoperative biometry or you can develop a interventional technology or you can develop a robotic or be involved in helping robotics teams to develop technology. It’s exciting.
I think for me, it’s been a nonlinear path and every time I talk to many of my colleagues medical students; we have brilliant young professionals budding from our Mount Sinai Medical School and our program, our residency program, and all these days want to be innovators and they all want to do something similar than purely practicing clinical medicine. It’s very hard because there is no textbook, there is no necessarily a program, it’s not a programmatic approach, it’s nonlinear and it does require some risk-taking along the way where you wouldn’t know the exact pathway of how you get there.
I think for me, to your question, the last 20, 30 years, it’s been very exciting and I’ve met a lot of people that I otherwise would not have interacted with. I have friends who are on all kinds of specialties, not just glaucoma or cataract or retina, they’re all around because we’ve worked together, we’ve developed innovations and we’ve developed new treatment approaches and ultimately we have been able to transcend the very clear boundaries set forth in our very specialized world, which is the fun part of intervention.
Mark Dlugoss:
You’ve been very adamant about the slow pace of product development from concept to market and medicine. Since product development’s becoming more complex, you believe that if innovation is just to succeed, more collaborative approaches are needed, especially with industry. How would you describe your approach to medical innovation and what needs to be done to improve that cycle of product development?
Sean Ianchulev, MD, MPH:
One of the many mentors that have been impactful along the way has been Bob Sinskey and he’s an innovator. I mean, at the time, one of the first phaco surgeons on the West Coast; I actually worked in his practice and interacted with Bob and he invented the Sinskey Hook or came up with the Sinskey Hook. It’s very interesting how we still use the Sinskey Hook; it’s really a common surgical instrument. He took an instrument and bent it, and there you go, that became an instrument that he immediately stuck in a patient’s eye, tried it out and started using it. There was no FDA approval, there was no quality controls, no clinical studies, it was quite experiential.
From that, from more than 40, 50 years ago, come today where everything you have to do has to go through a very, I would say inflexible, but at the same time, maybe the proper word is standardized and well-established regulated path of productization and no longer we as clinicians are the only important factor in that. The clinical part is important, but there is engineering involved, regulatory, there’s cross-functional. It’s very difficult today to do what Bob Sinskey did back in the day, bend the hook and stick it in a person’s eye and turns out it’s great.
It seems today you have to be really functioning in a team. You have to surround yourself very quickly. I think most importantly, you have to try to pressure test your ideas and very quickly eliminate the bad ones or find the path forward that makes sense. Now it’s going to change. For example, when I first started out on the journey for intraoperative biometry and we did the very first approach within biometry to derive the power of the intraocular lens, and I remember I was in residency, this was a resident project, and at the time I don’t think anybody cared that you’re one diopter off from your target refraction and you have to wear glasses. I mean, at that time, just doing cataract surgery and being able to have a best corrected visual acuity of 20/20 or 20/40 was great, who cares if it was plus two or minus two?
When we came up with a methodology to do that, and also as LASIK was becoming a lot more popular, it was a big challenge because those patients who paid for refractive surgery when they came out to have cataract surgery, they could not have great outcome. As we were solving that problem and we had a very good idea that we could solve it, most physicians did not care, in fact, a lot of people say, “Well, Sean, who needs that?” You can be within half a diopter or a diopter of cataract surgery, that’s great. Now you go forward 20 years and people care being within 0.25 diopter or being absolute amyotropia when we talk about premium cataract outcomes. Again, it’s one of these things that you really, when you start the journey, you don’t even know where you’re going to end up and you don’t even know the clinical utility of that product because even if you do market research, you’re never going to get a very validated or very valid answer.
I will give you another example. When Genentech embarked on the development of Lucentis, and of course this is an offshoot of another product from oncology, so they were very at first frustrated and surprised when they realized that when they interview retina specialists at the time, that was before intravitreal injections were common, and there were probably only 1,000 intravitreal injections in the entire country that were done for endophthalmitis and panophthalmitis. But when you go out and sample a number of retina specialists and you ask, “If you have a great therapeutic that can totally change the outcomes in macular degeneration, would you use it?” They’ll say, “Of course we will,” but when you say, “Well, you have to inject it in the eyeball intravitrally once every 2 or 3 months or every month,” and immediately everybody says, “Well, you don’t have a drug. Thank you very much.”
Again, now going forward, you realize that with millions of intravitreal injections, that’s not the case. But how do you innovate when there’s so much uncertainty? I think that’s part of the risk-taking that you have to believe yourself, you have to pressure-test it, and you have to obviously change your path, circumnavigate some of the challenges because it’s not as clear cut and as linear as training to be a great cataract surgeon, glaucoma surgeon, retina surgeon, where we have a very predictable linear approach.
Mark Dlugoss:
In terms of engineering and marketing and clinical aspects of a product, how much involvement is engineering? Let’s just use that as an example. I think engineering is very important, at least from my view. I don’t know, maybe you see it differently.
Sean Ianchulev, MD, MPH:
I think engineering is important, but I think the application and the clinical relevance of it is even more important. Just like also developing any kind of research drug or therapy in the lab, understanding where it fits and in which disease and how you can target it and at what point of the disease spectrum is also very important, right?
I keep laughing because I’ve learned to speak engineering, I’ve learned to speak some of the R&D because obviously it is a different language, but I think being able to translate it is very important. You don’t have to be an engineer, you have to understand the engineering, how engineering works. More importantly, I think you have to understand engineers and you have to be able to translate it into their terms because many, many a time they would spend so much effort to do something that they see as the next logical step, but really for them, a big part of the equation is missing, which is the clinical application and the actual clinical relevance and how to productize it.
To me, engineering is important. You need to get as good engineers as you can obviously, but it’s a talent like any other, and it’s a technical skill set that can be deployed like any other resource to solve a problem, but you need to figure out which problems to solve and which not to solve and how to apply them. I’ve been very lucky to work with great engineers, for example, brilliant people from Precise Robotics, which is a company that we ended up selling to Zeiss and they developed the kind of first clinical robotic system using clinical use. I’ve been now interacting and working with some of the team at AI Health that have one of the best technology that got FDA approval for autonomous diagnosis of diabetic retinopathy for 10 seconds. I’m working with brilliant engineers that are developing the next category of bio-interventional technology, the first biologic stent in medicine, so to speak, made of 100% percent bio-tissue biomaterial and interventional technology for cataract surgery.
Again, no matter which way you go, I think it’s great, it’s very refreshing, very youth promoting to be working alongside and solving the problems with that, but more importantly, to direct them to solve the clinically relevant problems that need to be solved and they know how to do their other stuff. I think for us as clinicians, it’s such a great escape and so to move out of the trenches in the clinics, which are great, but it’s a great diversion to then immerse yourself in working with other brilliant people, whether it’s programmers or computer scientists or mechanical engineers, bioengineers, and so forth to develop something novel.
That’s not new. I mean, research and development, a lot of physicians did that academia research and development in clinics. But I think now the application of it and the innovation factor where to me it means applying it much faster and getting it to patients much faster. You mentioned speed of innovation. I think sometimes there was one piece we had about the inpatient innovator, I think the question I have for every engineer, of course eventually they all figure it out, they all can come out with a great solution, but my question to them is like, what took so long? Why does it take so long to get there? Sometimes it’s a function of the problem, sometimes it’s a function of us not really articulating the best path forward.
One of my moments on that was when I was asked to go to Congress at the Energy and Commerce Committee that regulates the FDA to testify about innovation and the speed of innovation and whether we are over-regulating it in the US. That was one of the moments when I remember it was grueling heat, 100+ degrees in Washington DC, and you’re being grilled by all these congressmen that are trying to understand if America is setting the right tone and the right balance between innovation and regulation. One of the interesting thing is that as we spoke about that with the regulators and also with the congressmen is there are situations where we can move fast.
For example, intraocular lenses, there are a lot of intraocular lenses that are not available in the US and there are a lot of intraocular lenses that are all over the world. Now in order to get in the US, you have to do a clinical trial which sometimes involves 100, 200, 300 patients. Well, to me it’s kind of ironic because by that time in some countries there’s already experienced with 60,000 patients who have received the lens. I mean, the amount of data that we have, do we have to really do that in such a sequential way? Do we have a better way to do it?
Hopefully, artificial intelligence may be a smarter approach to innovation and regulation, will bring a more direct path forward. Because one of the things that’s exhausting and one of the things that really I think is really impeding bringing great therapies to patients and it’s exhausting the innovators is sometimes the overly burdensome regulatory environment that we have and the complexity and bureaucracy of bringing those drugs and devices to patients. There has to be a nice balance for sure; we want the public and the patients to be safe, but it’s very hard to sometimes know whether you’re going too far one way or another.
Mark Dlugoss:
You touched base on my next question pretty much, I was going to ask you about your talks before Congress. I guess another concluding question I have to that would be did you find any positive conclusions? Were you able to draw a positive conclusion from those conversations with Congress? Do you see medicine, particular ophthalmology, being more receptive with the new administration in 2025?
Sean Ianchulev, MD, MPH:
Well, I think the new administration in 2025, we have yet to see, right? I think that with everything, words are a good start, but I think that intent sometimes can get diluted by the time it becomes implemented. Let’s see where that really goes. I think a lot of things will be disrupted in the next 10 years because of deploying better tools, smarter technologies, systems, AI that can really, really improve things on both sides, on the development and industry side and also on the regulation side.
I think that when I was in Congress and we talked about that, I don’t think that was in any way a complaint to the regulators at the time, and it wasn’t because when you look at that, they themselves also want innovation to transpire. I think even the FDA wants to see, “This year we approve that many drugs, this we approve that many devices,” because that’s how they move the ball. I think that’s fine, it’s just the concept of least burdensome sometimes is a very difficult one to negotiate because Congress mandates the FDA to do that in the least burdensome way. But that’s like many other things, like reasonable or necessary or many other concepts like that is very difficult to completely distill and it’s very difficult to get a really strong position on and strike the balance.
But I think the fact is when we looked at the kind of technologies we’ve seen and products we’ve seen, it’s actually been quite amazing the last 20, 30 years or more. There’s been a lot of innovation; look at cancer, look at even in ophthalmology, we always want more and I think we always want faster and it could get faster and could get better. But at the same time, we’ve done it in a way where we haven’t repeated some of the disasters of the past like tamoxifen and some of the other issues that really caused pain. Look at what happened during COVID, how quickly we were able to turn around and get therapies and vaccines and whatever we thought was necessary, literally building out the plane in mid-flight and putting together all the pieces that was a demonstration.
We could act well and things can happen, not always to the best satisfaction, but I think that we’ve really witnessed a great pace of innovation. I just came back from CES and CES was all about healthcare this year which was great, the Consumer Electronics Show. I think we’re going to see a ton of pressure where innovation in the wellness business, so to speak, not necessarily medicine, which of course wellness and health is less regulated than medicine and medical devices, but I think that this is where all these new consumer electronics are going to be game-changing and the data they’re going to bring to bear would also be very interesting. I’m very optimistic that the next decade, we’re going to see a lot more excitement and it’ll be fun and it’ll be very dynamic for innovators.
Mark Dlugoss:
It’s good to hear that at least the Consumer Electronics meeting is generating things on healthcare. That’s great. Your latest venture is Iantrek, which is a medical device company that focuses on the development of advanced micro-interventional surgical technologies. As an entrepreneur and innovator, what is different about Iantrek compared to other companies and ventures you’ve been with?
Sean Ianchulev, MD, MPH:
Well, I’ve been kind of in some ways, the innovations we’ve always undertaken have been on the more challenging side. I call them sometimes categorical innovations. You’re not just improving an existing product, but you kind of working toward a new category. For example, when we did intraoperative operometry, there was nothing that was really in the operating room when you have digital technology and diagnostic imaging technology. We stuck an infrared laser to do intraoperative operometry. Then also that was one of the first devices actually that beamed that data to the cloud and that’s why we could do a lot of outcomes measurements because we had the analytics and all the data in the cloud. That was 20, 25 years ago, that was very, very unheard of.
When I look at Iantrek today, this is very exciting because we are opening a whole new category. You mentioned micro-interventional glaucoma surgery, which is MIGS. It’s a great paradigm. We actually call this new category BIGS. Why? Because it’s bio-interventional glaucoma surgery. We’re creating new stents, new scaffolds, new implants that have nothing to do with the traditional hardware devices where you have implantable hardware, whether it’s plastic, metal, that’s inorganic hardware that most implants are made of. What we’re doing with Iantrek, we’re actually creating bio-interventional implants so we’re merging biology and bio-tissue with interventional technology so that we can create a bio-interventional solution for problems like glaucoma, and now we can use this bio-tissue and those implants that are made of 100% biologic and biomaterial, not a micron of hardware, metal or plastic. We know today people are really concerned about having plastic and microplastics and all that.
This is all 100% biologic and we’re able to go in and really improve the structure and function inside the eye in order to lower the intraocular pressure. We’re able to stand open the uveoscleral space. We’re now creating things in the canal, bio-interventional approaches, and all of it is really using bio-tissue, which is very, very groundbreaking when it comes to stenting approaches. There is no 100% biologic stent in medicine, I think what we’re doing is probably the first one. The beautiful part is that you are receiving what we call a homologous bio-tissue enhancement of your anatomy and function. That is because this tissue is really as nature intended, it’s allograft tissue that has been processed, it’s acellular, and it is way better when it comes to implanting in the eye because it’s designed to be there and it’s designed to elicit the lowest possible foreign body response.
I’m very excited that through Iantrek, we’re creating not only a new product for something which is very unique in glaucoma, we currently have no ability surgically to enhance uveoscleral outflow, and we know that’s the main outflow in the eye. All the drugs that are most efficacious prostaglandins, they work through the uveoscleral outflow, but surgically, we have no pathway to the uveoscleral outflow today. By what we’ve developed in Iantrek, we are now able to enhance the uveoscleral outflow, which is a game-changing approach, but more importantly, we can enhance it using bio-interventional technology, which is also a categorically different innovation. Now we are able to apply that in the canal with the canal scaffolding technology.
We have some other things that we’ve really invented that are very exciting. They’re exciting because we’ve put together engineers, we’ve put together developers, clinical people, commercial people from the 2 companies that have actually done it before and have taken technology through the ringer into FDA approval into patients between medical and Iantrek, so we have people from both, I call them the tribe is from those 2. It is great to see everybody really being super energized because they see how much we’re changing. In this company we have 3 technologies, almost 3 companies into 1 because they’re 3 distinct, highly differentiated, best-in-class technologies tackling glaucoma. We could go in and tackle other things because bio-interventional does not have to stop with glaucoma.
But that’s kind of the exciting part is we’re creating a new category filling white spaces, new solutions that currently don’t exist, never been done. We like doing that because this is the excitement of really innovating something that’s not just incremental, but quite different.
Mark Dlugoss:
How do you perceive the future of what you call bio-interventional surgery techniques and technologies? How do you see that merging in ophthalmology and maybe other forms of medicine?
Sean Ianchulev, MD, MPH:
Oh, I think that if you look at it, somebody tells you what do you think is the best implant for certain area in the body, you will find out that the best implant is biologic that utilizes homologous, implantable technology homologous to the tissue where it’s going. I think a lot of people have done research in implantology and implants, and you find out that when you put an implant, the body obviously mounts a foreign body reaction or response which results in fibrosis, and that is really minimized if your implant is homologous or more homologous to the surrounding tissue where it’s going. Matching biology and doing bio-tissue that belongs there, you’re putting scleral allograft next to native sclera. You’re putting the mineralized bone next to bone where you go to the spine surgery. Matching that is really highly advantageous because that’s homologous material and it’s biologic.
The future I think is very exciting. We’re just starting, scratching the surface. We’re starting with really microtrefining and modifying homologous allograft materials. But think about the future, the future could be cellular therapies where you’re growing things in tissues that are tissue engineering or 3D printing, 3D printing biologic matrices. I think that a lot of this will start changing to the point where we are going to start using more and more, I think, biologic and biomaterials in human biology because they are better and they will be better and will be designed better than some of the artificial inorganic hardware materials that we currently use.
Mark Dlugoss:
Iantrek has launched 3 new products into this bio-interventional surgery new development, I guess if you want to call it, technologies. Let’s talk about the Cyclopen system, the AlloFlo, and the C-Rex. Can you break that all down for us and what’s the purpose of these 3 systems, the products rather, and where do you plan to take it all?
Sean Ianchulev, MD, MPH:
Right, so I think again, you’re right, we have at least a couple 3 that we’ve really disclosed and launched of recent. I think Iantrek came out of stealth at the time of the ASCRS last year in 2024. A lot of it was done, we just kept our noses to the grinder and wanted to develop the technologies, validate it, do the clinical trials. It was a bit of a surprise when it came out because most people usually see technologies for a long time at different venues, and we really decided to focus on execution and productization and talk less about it until we’re getting to the point where the technology is ready for prime time.
We do have first one thing that we’ve really reimagined, we’ve reimagined the renaissance of cyclodialysis, one of the very first glaucoma procedure starting in 1905, 120 years ago, which was used for almost 3, 4 decades almost completely as the most prevalent glaucoma procedure was cyclodialysis, and it went from Ab externo and then went to Ab interno. It was probably one of the first Ab interno procedures back in the days. Recently we did a review, I worked with Bob Stamper on a meta-analysis on cyclodialysis the years, there’s more than 40+ publications on cyclodialysis. But cyclodialysis got displaced by trabeculectomy. Of course, they were very severe eyes, and then we kind of forgot about it, and we did not really innovate much around that.
We see other technologies like for example goniotomy was forgotten or very niched out, and 10 years ago, goniotomy became a lot more used and people found better applications because there were better technologies. I think that’s very similar. We’ve come up with the Cyclopen system that is able to create a very controlled, minimally invasive interventional cyclodialysis. That is really a reinvention of the cyclodialysis surgery.
Then another technology and another invention is really the bio-interventional approach, which includes an interventional approach to the tissue. We’ve used scleral allograft for many years, and we’ve used it in a very limited way, for example, covering tubes or trabs, and we’ve never really thought about how that can be extended because scleral tissues is great. It’s 90% collagen, it’s permanent, durable, acellular, porous hydrophilic, and has great structural stability, and we’ve never really used it. Well, when you apply interventional technology to it, you can now microtrefine it and modulate it to make it whatever you want. In our case, we’ve been able to make it into a micro-interventional spacer by scaffold that can reinforce the scleral wall, that can reinforce the uveoscleral outflow pathway that can reinforce a cyclodialysis and that can reinforce other structures in the eye, subretino optic disc pits and so forth. All of that can be done in a very elegant approach using interventional instrumentation. That’s our interventional aspect.
Off of that, I think you’re going to see Iantrek bring a lot of surgical innovation. It’s not going to be just uveoscleral, it’s not going to be only trabecular, it’s going to go in many other places because we’re opening a platform approach to bio-intervention. That being said, the third technology, which is the C-Rex, C-Rex stands for canalorhexis. Basically it’s a different approach to canal that we haven’t done before. I think almost everybody now is trying to look at the canal, and there’s a lot of technologies kind of doing the same thing going in a sector or a segment of the canal, 60 to 90 degrees. They’re limited to their intervention because they don’t use flexible interventional technology. There are some catheters that have been adapted to go 360, but they’re not designed to do canal intervention in a way that it removes excisionally the sebecular meshway.
Based on my experience from Iantrek, which is a nitinol based technology that we created for cataract surgery, we actually are able to laser cut a nitinol filament, which is a super elastic memory shaped filament technology that can now go from zero to 360 degrees circumferentially and address the entire canal in an excisional way, both inner and outer wall. We’ve never done anything to the outer wall, we don’t have outer wall technology. The C-Rex can do because it’s fairly firm, it uses nitinol technology, it’s able to address both the inner and outer wall, it’s able to dilate the canal and it’s able to excisionally address the anatomy.
This is great because we’re doing things that have never been done and are a comprehensive solution to the canal. This is micro-interventional because this does not leave an implant. This does not leave bio-tissue or anything else, but we came up with this from an engineering perspective and we’re very happy because I think this would allow surgeons to address and do a non-implantable canal intervention in ways they haven’t done before.
Then we have other bio-interventional canal technology we haven’t revealed that may be coming in the next 12 months, but again, sometimes you have to as we come out, we do technology. We need to focus now to rolling and getting those two technologies out, but we’re probably, Iantrek is one of the companies with the richest and most comprehensive pipeline of glaucoma interventional technologies. It’s not just 1 company, it’s actually 3 companies in one.
Mark Dlugoss:
You just recently introduced these products into the ophthalmic arena, haven’t you?
Sean Ianchulev, MD, MPH:
Right. We started out in June, July, we completed the clinical studies. We’re rolling out 5, there are 5 presentations at AGS, so this will be a meeting rich of presentations. We had quite a few at AAO and ASCRS. We had publications that came out in 2024, 3 publications of the technology. We’re very, very excited. Surgeons are embracing it. We are not available to everybody quite yet, we’re doing a very methodical rollout with 2024/2025. We’ll be just focusing on centers of excellence and really partnering with key surgeons because it’s a categorically different technology. Again, we’re a small company, we’re not going to go out with 100 reps going out at this, we want to do it slowly, methodically, we want to be careful as we roll that out because this technology can have a disruptive impact. It can address the spectrum of glaucoma way beyond where we currently have technologies reside.
Mark Dlugoss:
What kind of outcomes are you receiving with the whole system?
Sean Ianchulev, MD, MPH:
I think in terms of the uveoscleral outflow, bio-interventional technology, the AlloFlo, with the Cyclopen, we’re seeing exactly what we expected to see. Uveoscleral outflow is the most efficacious therapeutic target, has the highest therapeutic index. We see that in glaucoma medications. In terms of efficacy, the best ones are prostaglandin analogs. They are only working through the uveoscleral outflow. There is a reason for that because uveoscleral outflow has a huge absorptive capacity, and we’re working with tremendous people in the space with Dr. Weiner, Ike Ahmed, with Dr. Ray Leon, people that are not just about addressing the mild, but they want to really impact the disease across the spectrum.
We’re seeing that technology be very, very, I would say, versatile. It’s not just for the mild cases. In fact, when we see how surgeons are using it now, almost half of our cases are in standalone glaucoma. That’s a very, very big testament to the technology because standalone glaucoma, you have to take a patient to do a glaucoma surgery for only one reason to improve their glaucoma. You’re not taking them to cataract surgery where, by the way, let me also treat you for a glaucoma, and if we hit it, great, if we don’t hit it, no big deal, we’re trying to piggyback another procedure.
Usually the patients, surgeons take for standalone glaucoma are moderate to moderate-plus. We have half of our cases in mild to moderate just like everybody else, but half of them, more than half, are in the moderate plus category. Other technologies that are mixed, that percentage is not 50%, it’s like 5-10%. So we’re about orders of magnitude where surgeons are using that for real glaucoma. When we publish the results, we’re seeing a safety profile that’s very much in line with all the mix that we have, and we’re seeing a very compelling efficacy profile.
It’s really consistent with the fact that we’re intervening in the space in the physiologic space, which has the highest therapeutic index, which is the uveoscleral space.
Our gonio-interventional technology with the C-Rex, I think it just allows you to do much bigger interventional purchase on your surgery on the canal, where you can do not 60 degrees or 90 degrees, you can do 180 or 360, so you’re not limited by the inadequacy of our instrumentation. Then we were able to also impact the outer wall. We haven’t introduced the outer wall technology quite yet clinically, but we’ve done studies with Carol Torres in outflow that show that when you remove the inner and outer wall, you’re getting about 30% higher outflow. We’re very excited about that as well. Again, we’ll introduce the C-Rex outer wall probably in 2026.
Mark Dlugoss:
That’s the C-Rex Duo, right?
Sean Ianchulev, MD, MPH:
C-Rex Duo, yes.
Mark Dlugoss:
Yeah, you mentioned that one and the AlloFlo device.
Sean Ianchulev, MD, MPH:
AlloFlo, yeah.
Mark Dlugoss:
Well, obviously the C-Rex dual is going to come out in 2026, but where are we standing with the AlloFlo?
Sean Ianchulev, MD, MPH:
Again, this is still in our development pipeline, and again, the technology will probably be something we’re going to introduce sometime in 2026. I think that as a small company with already 2 products that are coming out and they’re all breakthrough kind of interventions, we have a lot to do in the field and we don’t want to overload doctors. They’re also practicing and they cannot learn necessarily too many things at the same time, we don’t want to overdo it. Again, we need to temper our enthusiasm for innovation and bringing something new. Let’s first mature the current pipeline and then we can introduce the new, but it’s so good to see what we’ve done and what’s to come, even if it’s not going to come out, we’re going to put it right on display this year or in the next 12 months, but we know what’s coming and it’s very, very exciting to see the innovation and the whole new category of bio-interventional technology come together.
Mark Dlugoss:
We’ve covered a lot of ground today covering innovation in ophthalmology innovative technologies for glaucoma and, of course, your new venture in Iantrek. Are there any points of discussion we may have overlooked or is there anything you would like to add regarding the company and the state of innovation in ophthalmology?
Sean Ianchulev, MD, MPH:
Well, I mean before you and I started this, I told you you have to compress those things into 6-minute TikTok videos, right? Because the day and age of attention span for people. I think we’ve talked plenty. Of course, I’m involved in a number of other projects and I think it’s very exciting to see technologies being able to now impact our field. But yeah, there is hopefully more to come. I think Iantrek is going to be really interesting and impacting a lot of us practicing glaucoma in many ways, more than one for sure. I think there’s hopefully going to be some of the other innovations I’m involved in, digital health and oculus surface and so forth. There’s some interesting technologies that may also come over the next 12 months.
Mark Dlugoss:
Great. Hopefully we can bring you back for another edition of The Ophthalmic Project, and we’ll be able to discuss some of these other new technologies you’re working on.
Sean Ianchulev, MD, MPH:
Thank you. Look forward to this.
Mark Dlugoss:
Well, that concludes today’s Ophthalmic Project podcast. I want to thank Dr. Sean Ianchulev for sharing his thoughts about ophthalmic innovation and his latest venture Iantrek. As of always, I want to thank you, the viewers, for watching, and I hope you’ll join us for the next edition of The Ophthalmic Project. Thank you and have a great day.
