This episode of The Ophthalmic Project spotlights a novel, non-invasive glaucoma treatment developed by ViaLase using femtosecond laser technology. Host Mark Dlugoss and ViaLase CEO Shawn O’Neil discuss the origins of the technology, its evolution from early laser research, and the development of the FLIGHT procedure, an image-guided, high-precision trabeculotomy designed to lower intraocular pressure. The conversation highlights how this incision-free approach differs from traditional treatments like topical medications, SLT, and MIGS.
Mark Dlugoss:
The landscape for the treatment of glaucoma currently consists of topical medications, filtration surgery, SLT, and MIGS. Now, there’s a novel non-invasive glaucoma procedure emerging that uses a femtosecond laser for an image-guided high-precision trabeculotomy. Hello, this is Mark Dlugoss, Senior Contributing Editor for Ophthalmology 360, and welcome to The Ophthalmic Project, powered by Ophthalmology 360. In today’s edition of The Ophthalmic Project, we will discuss this new femtosecond laser-driven glaucoma procedure with the company that will bring this technology to the ophthalmic market in the not-too-distant future. Joining The Ophthalmic Project is Shawn O’Neil, CEO of ViaLase, who will give us all the details. Shawn, welcome to The Ophthalmic Project.
Shawn O’Neil:
Thank you, Mark. Appreciate the opportunity. Great to see you and look forward to this conversation.
Mark Dlugoss:
Before we get into the details of the procedure and the technology behind it, I think it’s interesting we should discuss, I wouldn’t say the history of the company, but the prehistory of the company. The origins of ViaLase date back to the 1990s with the development of femtosecond lasers at both IntraLase and LenSX. Can you outline the early history and how the technology of femtosecond lasers evolved to a potential treatment for glaucoma?
Shawn O’Neil:
The origin story is quite interesting. It was a bit of a serendipitous coming together of 2 really innovative, intelligent people, Dr. Ron Kurtz and Dr. Tibor Juhasz, who is our founder at ViaLase. Basically, back in the 90s, the physics lab in Michigan realized the opportunity to create ultra-fast lasers. They were working on these ultra-fast lasers (ie, femtosecond lasers in their lab). Inadvertently, one of the grad students got hit in the eye with the laser beam. Where do they take them? They take him to the ophthalmology department. The resident on call at that time was Dr. Ron Kurtz. Ron, Dr. Kurtz examined the patient, examined the grad student, and was just amazed at how precise these cuts were and how there was no collateral damage to the adjacent tissue. At that moment, he felt like there was an opportunity to have application in ophthalmology.
From there, he teamed up with Dr. Tibor Juhasz, who is a laser physicist and again, the founder at ViaLase. They started to look at what applications they could have for ophthalmology. What’s really intriguing to us now that we are focusing on glaucoma is the initial treatment that they were looking for was actually a glaucoma treatment. There were some limitations to the technology at the time that didn’t allow them to access the iridocorneal angle. They focused on the cornea, and that’s what created IntraLase, and then continued focus on the cornea and then the cataract lens, they created LenSX. Now, with the advancements that have occurred, we’re refocused on glaucoma.
Mark Dlugoss:
Can you give a little bit more of a background of what Dr. Juhasz’s research was back then and what were the factors that led him to delay the laser treatment for glaucoma?
Shawn O’Neil:
As I mentioned, there were some technical limitations. What was great is they had the ultra-fast laser, so they had the benefits of precision, the benefits of the non-collateral damage to adjacent tissue that they were seeing from the very early stages. Really where the challenge came from is probably more in the imaging systems at the time and the ability to target the laser into the iridocorneal angle. The reason why the iridocorneal angle or the conventional outflow pathway for glaucoma is unique in that manner is because it’s a very tight space. You really need to be able to focus in at the micron level. To put that in context, the human hair is about 50 microns, and we’re targeting down to single-digit microns. You can just think of just one-tenth of a human hair is where we’re focusing. That’s where now we have imaging systems, both gonio imaging, high definition gonio imaging, as well as micron-level OCT imaging that allows us to focus the femtosecond laser beam on the trabecular meshwork.
Mark Dlugoss:
Building upon his experience with the femtosecond lasers at IntraLase and LenSX, Dr. Juhasz founded ViaLase in 2017. Could you provide a brief history of ViaLase and what technological advancement surfaced that opened the door for the company and Dr. Juhasz then pursue his vision for a non-invasive glaucoma treatment?
Shawn O’Neil:
The advancements were really in the proprietary imaging systems that we’ve created here at ViaLase. We have a high definition proprietary gonio camera that gets down to the micron level and be able to focus into the iridocorneal angle. Then we also have micron-level OCT, a proprietary system that is the highest resolution OCT that we’re aware of on the market. These are both so important because we’re focusing the laser beam onto the trabecular meshwork, and the trabecular meshwork is about 100 microns, 150 microns thick. Our technology is able to focus onto the trabecular meshwork and create a volumetric removal of the trabecular meshwork (ie, an aperture, which is why we’re performing a trabeculotomy, which is a much different mechanism of action of other lasers that are used in this space).
Mark Dlugoss:
The leadership of ViaLase has vast experience in developing, designing, manufacturing, commercializing femtosecond lasers for ophthalmic surgery. Let’s discuss the ViaLase leadership team and what they bring to the table for ViaLase as the company moves forward toward the commercialization of laser treatment for glaucoma.
Shawn O’Neil:
Dr. Juhasz, as the founder, has just done an amazing job of surrounding himself with talented individuals that are steeped in femtosecond laser. He’s brought over individuals that have broad experience in femtosecond lasers in ophthalmology from his IntraLase experience, from the LenSX experience, and not just designing and developing them, but manufacturing and operationalizing these systems. In addition, he complemented that leadership team with a very, very strong clinical, medical and commercialization experience. Not just with femtosecond lasers, but specifically in glaucoma devices. When you marry this strong technical leadership team with a very strong clinical regulatory commercial team, we believe that we have a best-in-class team top to bottom. Not just in leadership, but throughout the entire ViaLase organization that’s really giving us a leg up in terms of bringing this technology to market. To give you a couple of quick examples, the ViaLase ViaLuxe laser system has a smaller footprint than any of the other femtosecond lasers. That’s because of the value of the development team.
We believe that we’re going to be having a headstart from a clinical and regulatory and commercialization standpoint because of our vast relationships in ophthalmology, specifically in glaucoma, and especially now with comprehensive ophthalmologists doing MIGS and other glaucoma treatments, we’re leveraging those 30 years that we’ve been in ophthalmology to make sure that we have the marketplace primed and ready for this great technology.
Mark Dlugoss:
You mentioned the ViaLuxe laser system. This is the product that’s designed to perform the non-invasive glaucoma procedure, which you’re referring to, you call FLIGHT, which has an acronym for femtosecond laser image-guided high precision trabeculotomy. Obviously, it’s designed to lower the interocular pressure. Please provide a clinical outline of the FLIGHT procedure, how it works, what’s the overview of it, and what needs to be done for surgeons to do this surgery.
Shawn O’Neil:
The ViaLuxe laser system, in combination with our patient interface, which we refer to as the ViaLens patient interface, is what is used to perform the FLIGHT treatment. FLIGHT stands for femtosecond laser image-guided high precision trabeculotomy, and that’s an important term because there’s a lot of different ways to address the conventional outflow pathway. We do it very specifically through this femtosecond laser image-guided high precision trabeculotomy, creating an aperture in the trabecular meshwork. The way that’s done is we are able to perform an incision-free non-invasive, very precise trabeculotomy with the femtosecond laser that is guided by both high definition gonio imaging for the doctor, as well as live OCT imaging for the doctor.
The reason why the patient interface is important though, is the ViaLens patient interface, as the patient is docked to the laser in very similar fashion as any other femtosecond laser, our interface is unique and proprietary in that it not only couples the eye to the laser holding the eye still. It’s actually the last optic in the optical path of both the imaging system and the femtosecond laser, which allows for that micron level precision and the benefits of the femtosecond laser to create that 500-by-200-micron aperture in the trabecular meshwork.
Mark Dlugoss:
What advantages do you see for the surgeons in performing this? Obviously, it’s a little more precision, I would assume, but can you outline some of the advantages?
Shawn O’Neil:
We believe that this is going to be an expansion opportunity into the surgeon segment and the comprehensive ophthalmology segment because one of the challenges of any angle-based procedure in glaucoma is the imaging and the learning curve and the comfortability with intraoperative gonioscopy, which has challenges. We solve those challenges with our high definition gonio image coupled and complemented with our OCT imaging to where it’s very much within a comprehensive ophthalmologist skillset to perform the femtosecond laser procedure. The imaging allows them to really hone in on the physiological landmarks of the trabecular meshwork, which will give them high confidence that they’re placing this aperture in the same place every time. We know historically with, for example, MIGS devices, some reports show that up to half of them are misplaced. We solve that issue with our precision, as you mentioned.
On top of that, we have the safety of the femtosecond laser. Femtosecond lasers have proven to be safe and effective in ophthalmic surgeries over literally tens of millions of cases when you combine LASIK cases with IntraLase as well as the cataract cases with devices like the LenSX laser. That safety profile has continued to be present in our glaucoma procedure as well. It’s really a great combination of that precision to increase efficacy and then the safety of this great technology.
Mark Dlugoss:
Based on all that, can you provide the key differences and outcomes between the FLIGHT procedure and the current glaucoma treatments out there, most specifically SLT?
Shawn O’Neil:
When you look at the comparison between our FLIGHT treatment and then the SLT treatment, I think that the largest misperception is that they’re both lasers, so they must be doing the same thing. That is categorically not true. Our laser is creating a trabeculotomy, again, an aperture in the trabecular meshwork. Doing a volumetric removal of the trabecular meshwork through the photo disruption process of the femtosecond laser, which creates a physical connection then between the anterior chamber and Schlemm’s canal, which allows for egress of the aqueous humor, therefore lowering intraocular pressure for patients that are suffering from glaucoma.
Whereas SLT’s mechanism of action is more of a heating up of the tissue of the trabecular meshwork and creating some kind of chemical mediation, but it’s not an actual trabeculotomy. It’s not an actual physical connection. That’s where we believe we’ll have an advantage in not just the increase of outflow based on creating that physical connection, but also in the long-term potential durability and safety of the procedure because we’ve seen in some of our long-term data that these channels are remaining patent for patients that are even being monitored out to 5 years.
Mark Dlugoss:
ViaLase laser system is designed to be used with the FLIGHT procedure. Would you outline the features of the actual laser unit? What is behind the technology of laser systems so that the FLIGHT procedure is completed successfully?
Shawn O’Neil:
The main function of the ViaLuxe laser system is what houses and is part and parcel of our femtosecond laser system, our imaging system, both high definition gonio and micron-level OCT. Then what we refer to as the surgical arm, which is what allows the patient to be coupled to the ViaLuxe laser system through the ViaLens patient interface. All those things work in concert to perform, to deliver this precise femtosecond laser image-guided high precision trabeculotomy and perform the procedure to create that aperture and the physical connection between the anterior chamber and Schlemm’s canal. Alongside of that is a very streamlined graphic user interface, which is the interface that the doctor or surgeon would use to perform the procedure. Our great experience that we have within our development team has really streamlined that user interface to be very much within their skillset and a very efficient process for them to perform the procedure.
Mark Dlugoss:
Can you walk the listeners through the step-by-step details of how an ophthalmic surgeon would utilize a laser for their own purpose of increasing the aqueous flow without opening up the eye?
Shawn O’Neil:
The unique thing about the femtosecond laser is it only creates the photo disruption activity at the point that it gets focused. The femtosecond laser, just like in cornea or cataract, in glaucoma will be transferred through the clear cornea to be able to be focused into the trabecular meshwork. At that point of focus is where the photo disruption will occur. What the doctor does is use the high-definition gonio-imaging with the micron level OCT imaging to identify the front surface of the trabecular meshwork and identify that focal point. Then it’s at that focal point that they will position the laser, and then they’ll step on the foot pedal, just like any other femtosecond laser, and deliver the laser pulses exactly to that focal point, not creating any collateral damage to any adjacent tissues, because again, that’s the hallmark of the femtosecond lasers, that precision.
Then when they execute the laser procedure, that then turns the trabecular meshwork into basically bubbles of water and gas, and then those get dissipated into the normal outflow system of the patient, and then you have the flow of aqueous directly in the Schlemm’s canal.
Mark Dlugoss:
Now, we’re all familiar with the current landscape for treating glaucoma, which has many options, and most of them obviously have been around a long time except maybe MIGS. How do you see the ViaLase laser system and the FLIGHT procedure fitting into that landscape? What I mean by that is, do you see it as a complement, like it’s another piece of equipment in the armament to fight glaucoma, or do you see it as a procedure that totally disrupts that landscape, thus transforming the treatment of glaucoma?
Shawn O’Neil:
We believe that we will be redefining the glaucoma treatment landscape, and the redefinition is going to be the ability to offer a surgical-like procedure (ie, a trabeculotomy) in a non-surgical manner (ie, an incision-free, non-invasive procedure like FLIGHT). We believe that that’s going to redefine and transform the way glaucoma is treated because since it is incision-free, it also does not have to rely on the patient to have a cataract, which is what the majority of the MIGS procedures do now. We believe that we’ll be able to truly unlock what has been referred to for a long time as the standalone market.
We have the ability to really look at that marketplace and provide a procedure that will be both attractive to the doctors from a delivery standpoint, as well as attractive to the patients because of its incision-free approach. We do know that glaucoma patients live with glaucoma their entire lives. It’s an entire journey, so we do realize that there will be other procedures and/or interventions along that entire patient’s lifetime. What we’re excited about, again, is we believe we’ll be able to treat that patient earlier with a very effective and safe procedure and be able to provide them with more options than what they have today.
Mark Dlugoss:
The first in human procedures for the FLIGHT procedure were conducted in Hungary in the 2020. Could you shine some light on those early clinical trials as well as the clinical trials of ViaLase just conducted since 2020?
Shawn O’Neil:
Our first-in-human trials were done in Hungary in 2020. They were predominantly safety studies, as you could imagine, in any first-in-human effort. The patients remained on their medications. We performed a single channel of 500-by-200 microns on each of these patients, and then we followed them out in the beginning for 1 year and then for 2 years. What’s great is what we saw along every time point for those patients is there were no serious adverse events. Demonstrating our hypothesis and continuing to prove the safety of femtosecond laser in ophthalmology, even in glaucoma. We’re very excited about that. At the same time, we were tracking IOP as a data point as well. At the 2-year time point, we saw an IOP reduction of about 34% in those patients.
It’s not a big cohort and they were still on medications because again, it was predominantly a safety study, but that gave us really a lot of confidence directionally that this also had the ability to lower intraocular pressure as we would’ve assumed being a trabeculotomy because trabeculotomies have been used for decades as a very successful, proven glaucoma procedure. We’re just now doing it in an incision-free manner. There’s now some of those patients just do normal follow-up that have been followed out to 5 years post those first treatments mark. We’re still seeing that they’re having very strong safety and very stable IOP lowering, which gives us directional feedback and a lot of excitement around the durability of this procedure long-term as well.
Mark Dlugoss:
I was amazed when I was doing research on the system and your company that the patients were seeing for up to 5 years with no problems. I’m going, “Wow, that’s impressive.”
Shawn O’Neil:
For glaucoma, which as we know is a lifelong disease that’s the leading cause of irreversible blindness, if we can provide a durable treatment to patients that’s both safe and effective, we feel like we’ve really, again, had the opportunity to redefine the way glaucoma treatment is approached.
Mark Dlugoss:
The ViaLuxe laser system received the CE mark in the European Union. I think it was last year, correct?
Shawn O’Neil:
Yes, sir. December.
Mark Dlugoss:
What are the next steps for ViaLase in terms of commercialization?
Shawn O’Neil:
We’re very excited about the opportunity to bring this technology to patients in Europe where we’ve identified 4 very strong distributors and key target markets for us as we approach a controlled rollout. We believe that this technology is going to redefine the way glaucoma is treated. With that, we know we have a responsibility and we’re focused on bringing this out to the market in a very responsible manner. We’re going to do a controlled rollout in just some key target markets. Really our objective is to demonstrate the doctor acceptance, patient acceptance, and the commercial viability of this device in those markets and then take those learnings and continue to build upon them as we prepare for our US launch.
Mark Dlugoss:
Now in December, the first patient was treated with the FLIGHT procedure in the US IDE trial that will obviously lead to an FDA clearance. Can you tell us about the trial and that first procedure?
Shawn O’Neil:
I love that you say it’s going to “obviously lead to an FDA clearance,” from your mouth to the FDA’s ears, Mark. We’re excited about that trial and we’re excited about being able to start to demonstrate the value of this technology in the US population. We began the trial of the US IDE trial, which will be used in pursuit of our FDA clearance. We’ve been very, very pleased with our pace of enrollment, and we’re looking forward to continuing to scale that enrollment in 2026, and just really excited about the feedback that we’ve been getting so far just in terms of the patient enrollment and just the doctor satisfaction in performing the procedure.
Mark Dlugoss:
It sounds like the ViaLase laser system, and the FLIGHT procedure, could really revolutionize how surgeons treat glaucoma. Are there any points of discussion we may have overlooked or is there anything you would like to add about ViaLase laser system and the FLIGHT procedure before we close?
Shawn O’Neil:
When we think about the ViaLuxe laser system and the FLIGHT procedure, we’re very excited about the opportunity to bring this to glaucoma patients. We do believe that this will be an expansion opportunity by bringing an incision-free, non-invasive femtosecond laser image-guided high precision trabeculotomy to patients that’s not going to require them to have a cataract. We believe that we’ll be able to expand the patient population that can benefit from these types of treatments. We also believe that it’s a surgeon expansion because of the familiarity with femtosecond lasers, because of our advanced and unsurpassed imaging capabilities, we believe that we’re going to be able to also get over that hurdle that some doctors may have about doing interventional conventional outflow or angle-based procedures at the time of cataract surgery because of some of those other idiosyncrasies we remove.
Ultimately, we see this as a great opportunity to redefine that glaucoma treatment landscape. Mark, we appreciate the opportunity that you and your team have given us here today to share our vision, share our mission, share the passion that we have for treating glaucoma and just helping those patients that have this unfortunate vision-threatening disease.
Mark Dlugoss:
If ophthalmologists, optometrists, or even patients want to know more information about the ViaLase laser system and the FLIGHT procedure, can they go to your website and see? I know you have a video of the actual procedure on website. Could you tell them where they can go to see that?
Shawn O’Neil:
They can visit www.vialase.com and there they’ll be able to stay informed of the technology, the procedure. As you mentioned, we do have a nice animation live video of the procedure, and then also all of our press releases. As current news on our progress against both FDA and our commercialization in Europe will be there for them to be able to track our progress.
Mark Dlugoss:
That concludes today’s edition of The Ophthalmic Project. I want to thank Shawn O’Neill for outlining ViaLase, femtosecond laser-driven glaucoma procedure. Finally, I want to thank you, the listeners, for tuning in. I hope you will join us for the next edition of The Ophthalmic Project, powered by Ophthalmology 360. Until next time, have a great day.
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