MIGS: Micro-Invasive Glaucoma Surgery – Challenges & Opportunities

Bringing together a diverse range of experts for the panel discussion on MIGS at the 2nd Annual Ophthalmology Innovation Summit, co-moderators Tom Samuelson of Minnesota Eye Consultants and Kerry Solomon of Carolina Eyecare Research Institute, lead panelists Tom Burns of Glaukos Corporation, Ron Bache of AqueSys, Inc, David Van Meter of Ivantis, Brian Walsh of Transcend Medical, Richard Lewis of Surgical Eye Specialists and Ike Ahmed of the University of Toronto through a conversation surrounding the present challenges and future opportunities emerging in the rapidly growing market surrounding MIGS.

Duration: 34:14

 

Speaker(s):

Tom Samuelson

Tom Samuelson
Founding Partner and Attending Surgeon
Minnesota Eye Consultants

Thomas W. Samuelson, a founding partner and attending surgeon of Minnesota Eye Consultants, is a board-certified ophthalmologist who specializes in the treatment of glaucoma, cataract, and refractive surgery. Dr. Samuelson completed his medical degree at the University of Minnesota and his residency training at the University of South Florida where he served as chief resident. He received his sub-specialty training at the Wills Eye Hospital in Philadelphia.

Kerry Solomon

Kerry Solomon
Carolina Eyecare Research Institute

Dr. Solomon has been a leader in the field of LASIK vision correction since 1996, when he performed the first LASIK procedure in South Carolina. He also performed the first PRK and iLASIK procedures in the state.

Tom Burns

Tom Burns
President and CEO, Director
Glaukos Corporation

Mr. Burns has provided the leadership for Glaukos since its founding in 2001 to create the premier device franchise in glaucoma treatment– a business that was recently ranked #19 by the Wall Street Journal in a review of over 5000 venture-backed companies. He has built substantial value, delivered rapid growth and created entirely new commercial product classes and global markets in senior leadership roles at three major, successful start-up companies.

Ron Bache

Ron Bache
President & CEO
AqueSys, Inc.

Ron Bache is President and CEO of AqueSys, Inc. AqueSys is a venture capital backed medical device company focused on the development, and commercialization of innovative, safe, and effective implantable devices for the treatment of glaucoma. Glaucoma is the world’s #2 cause of blindness, and affects tens of millions of patients globally. It is estimated that $4 billion per year is spent on glaucoma treatment. Bache has 18 years of experience in the pharmaceutical and medical device industry. He joined AqueSys in January 2009.

David Van Meter

David Van Meter
President & CEO
Ivantis

Dave joined Ivantis as President and CEO in January 2008. Prior to joining Ivantis, Dave held various positions of increasing responsibility in Marketing and General Management throughout his career, most recently at Abbott Vascular, where he began in August 2001.

Brian Walsh

Brian Walsh
President & CEO
Transcend Medical

Mr. Walsh is the President and CEO of Transcend Medical, which is currently conducting multiple international studies including a U.S. pivotal trial, for a micro-stent ocular implant designed to halt the progression of glaucoma, the leading cause of irreversible blindness in adults.

Richard Lewis, MD

Richard Lewis, MD
Surgical Eye Specialists

Richard A. Lewis, M.D. is the former director of glaucoma at the University of California, Davis. In addition to his busy clinical practice located in Sacramento, California, Dr. Lewis is actively involved in clinical research in national and international trials in glaucoma therapy.

Ike Ahmed

Ike Ahmed
Assistant Professor
University of Toronto

Ike K. Ahmed, MD is a fellowship-trained glaucoma, cataract, and anterior segment surgeon with a practice focus on the surgical management of glaucoma, complex cataract and intraocular lens complications.

Video Transcript

Tom: Good afternoon everyone. The format here is going to be each of the CEOs from the companies will give a brief update on where they’re at and we’ll just go in the order that they’re listed in the program here. They’ve been instructed to talk for a few minutes, show a few slides that they like, they don’t have to. I think most in the audience have seen at least introductory comments on each of the technologies and Ike gave a great overview. Tom Burns, you’re first listed here, why don’t you give us an update on what’s happening with Glaukos. They’re all miked up I think.

Tom Burns: Good afternoon. Thank you for having me here today. I’m going to, in a few minutes time, describe our current portfolio of MIGS devices and how we’re trying to create this marketplace. One of the things we’ve tried to do since our inception is to create a full portfolio of micro stent devices that would serve open-angle glaucoma from the earliest stage of disease to refractory or late stage disease. In doing so we’ve created two species of stents: trabecular bypass stents, which re-establish physiologic outflow through the normal conventional outflow pathway to reduce IOP, and we’ve created a suprachoroidal stent, which is in our pipeline, which uses this this uveoscleral tract and pathway to reduce IOP.
Let’s take a look at the first generation product. You’ve seen this before, you all got to the slide before I could. This is a look at scale here. We see our current stent on a Baerveldt shunt. This Baerveldt shunt is used now in late state refractory disease when all other pharmaceutical products and lasers and trabeculectomy have failed, but you get an idea of the size and scale. This product, our current stent, is .005(one five thousandth) the cubic volume of an aqueous shunt. It is the smallest implant that has ever been placed in the human body. It’s 1mm in length, it’s heparin coated, it’s made of implantable grade titanium, and it’s exquisitely important to reestablish physiologic outflow pressure in mild to moderate open angle glaucoma patients.

Here’s a further look at the product itself. It’s really exquisitely designed. There’s a trephinating tip that you can see at it’s distal end, this helps the product carve through the trabecular meshwork and be placed in the Schlemm’s canal. It has an underbelly and trough which protects collector channels and strata which are on the base membrane of Schlemm’s canal itself, which feed episcleral venous fistula and allow the fluid to flow into the body. The lumen itself that creates this patan channel is just a little bit larger than a human hair. It’s about 120 microns. This is
the product that, now, we have received FDA approval for. We’ve launched the product as of June of last year and we’re doing very well. We hope to bring you up to speed on that commercial launch during the discussion.

Our second generation product is called the iStent Inject. This product was based on our conviction that if we place more than one stent in the eye we can titrate circumferential flow within Sclemm’s canal, we could get more turbo charge power, we could get more aqueous humor out through the episcleral venous system, we could increase facility of outflow, and we could further lower IOP. Our challenge was that we wanted to do this in the most minimally invasive way. We wanted to make this into a pure injection therapy where we could make these stents small enough to fit inside a 26 gauge needle. So you see the axisymmetric design here. It’s got a mushroom head, where this head fits inside Schlemm’s canal and provides fluid flow. This stent is six times smaller that the first generation design, and it’s made in such a way where we can pack two stents in each of our 26 gauge needles. We call this project Pez. The surgeon will take this product and will enter with a small paracentesis from the temporal side across the optical axis, he just applinates the trabecular meshwork, he pushes a button on the applicator from outside the eye and this will automatically and in a governed fashion fire the stent into the Schlemm’s canal at a governable, predictable rate. He then will move three clock hours over and fire the second stent. This is all done in a single pass. You can imagine if you have glaucoma and you are told a diagnosis that you could start to take drops, you have the opportunity to do that or get a single injection under topical therapy for a system and for a technology that may give you relief from glaucoma and manage glaucoma for years to life. We think this is an extraordinary value proposition and will fully expand the MIGS
marketplace upon it’s introduction.

Our final product here is our suprachoroidal stent. This is a stent made out of poly ether sulphone, it’s 4mm long, and this ferries aqueous humor from inside the eye into the uveoscleral tract where it’s reabsorbed by the episcleral venous system after scleral diffusion. This product, we see, as a product that’s going to enhance. Once you’ve been able to mine conventional outflow use in the trabecular bypass stents you can use this product to be able to mine both physiological outflow pathways and enhance and further decrease pressure. We’re terribly enthusiastic about the use of
this product in combination with trabecular bypass stents to treat late stage glaucoma disease.

Finally, one of the things that’s important to know is that MIGS has reached outside of ophthalmology. The Wall Street Journal, in an analysis of privately held, venture capital backed companies, these are start up companies, took a look at 6,000 companies across multiple specialties. They evaluated those companies on the base of technology, on the basis of the management team, the investor group who backed the companies, and as well as the amount of capital raised. Of those 6,000 companies, Glaukos was ranked seventh in this survey. This is just a testament to the resonance of
MIGS therapy and what Glaukos and the companies here presenting today have been able to create in the marketplace. Thank you very much.

Dr. Kerry Solomon: Thank you, Tom. Next we’re going to learn and hear a little more about AqueSys. I’d like to introduce my dear friend Ron Bache.

Ron Bache: Thank you, Dr. Solomon. It’s a privilege to be with you here today and before I get started I would like to take a moment to congratulate Glaukos, Tom Burns, their management team, and their investors for a great accomplishment being the first one approved. That’s a great accomplishment in this journey. A little bit about AqueSys: Our technology is founded upon the premise that we want to utilize our technology to deliver highly effective IOP reduction. That’s why we do surgery in the first place, right? We have patients that have a blinding disease that need to get their IOP down. Our first premise in our design was highly effective IOP reduction. How do you get there? By using the gold standard mechanism of action which is subconjunctival outflow. That’s what is done around the world with trabeculectomies and tube shunts, but what we did is basically invert that. Our goal is to do it by a minimally invasive ab interno procedure utilizing a permanent gelatin implant that’s soft, non inflammatory, and tissue conforming. Also our goal, through our technology, is to be able to treat mild to moderate and refractory glaucoma. We’ve been able to demonstrate efficacy in all of those patient populations outside the United States where we’re approved.

They say a picture is worth a thousand words so I’ll use video and maybe it’s worth more than that. Today this is the gold standard in terms of IOP reduction. This is a trabeculectomy with an expressed mini shunt injection. As you can see, it’s an ab externo approach going from outside to in. Our goal with our technology, which I’ll show you on the right, is to get the same type of efficacy that you see there, but in a minimally invasive, broadly adoptable procedure. This is the Zen procedure on the right, clear corneal incision. This one is done, as Dr. Ahmed mentioned,
without a gonial lens, because we’re to trying basically miss the cornea and miss the iris. We don’t have to hit a specific structure in the angle, the surgeon is able, under a normal operating scope view, to see the inserter advance to the target location. We designed it to be very similar to an IOL injection, a simple turn of the injector, like delivering an intraocular lens to the bag, delivers the Zen implant to the desired location. What you’re seeing on the right side, by the way, is real time unedited. That’s the case. Our goal is to deliver 30%-40% IOP reduction from best medicated IOP, higher from a washout IOP, and to reduce the medication load. We’re able to accomplish that by utilizing a portfolio of permanent gelatin implants that are soft, compressible, and tissue conforming.

You can see that in the middle picture, an OCT image of our implant actually in vivo in a patient, courtesy of Dr. Ahmed. We have three implants: Zen, Zen Mini, and Zen Nano for all phases of the glaucoma. It is designed, as I said, to be very similar to delivering an intraocular lens to the bag for a cataract surgeon, but also we’re focused on the glaucoma surgeon and the glaucoma market. Not when medications are controlling pressure, but when medications are not enough to control pressure we want to be the first procedure done because it’s minimally invasive and highly effective.

Lastly, how do we work? Well, we just take the gold standard mechanism of action and do it minimally invasive-ly. Our approach bypasses all of the potential outflow obstructions. If it’s in the trabecular meshwork, the collector channels downstream, with our approach, in each patient, you bypass all of those potential outflow obstructions and yet we still spare the conjuctiva for all future procedures that can be done.

We’re very excited about the technology, we’re currently in an ID trial inside the United States for our first indication, and looking forward to doing great things outside the United States. It’s a privilege and an honor to be a part of this category. I thank you very much for your time.

Tom: Thanks, Ron. The next speaker is Dave Van Meter from Ivantis.

Dave
Van Meter: Good afternoon. First of all, it’s an honor and privilege. This is our first time at the OIS meeting so it’s really a thrill to be here. I also want to congratulate Tom and Glaukos on the tremendous work taking this category forward, it’s really exciting. It’s a privilege to be here.

We were founded in July of 2007 by two top coronary stent inventors looking to apply their fluid dynamics expertise to another area of unmet need. We’ve got 28 people in our company, 4 of those based in Europe. The company is based in Irvine, California. To date we’ve raised $63 million and we just concluded of that $27 million in January in a series B financing with a new outside lead investor. We’ve treated over 800 patients globally since December of 2008. We have our CE mark and our US pivotal trial is ongoing. As a company, one of the things we pride ourselves is what we call and our clinicians call being aggressively scientific. We invest very heavily in basic science research and we also believe in large, multi-center randomized control trial. As a company we’ve achieved all of
our goals on time and within budget for the last five years. If you could advance the slide. Dr. Ahmed showed this briefly, but this is an animated video. Could you go back one slide? If you just click on the picture there. Thank you.

This is the proximal end of the device that’s in the anterior chamber. You’ll see here the body of the device that resides for three clock hours in Schlemm’s canal, scaffolding and dilating the canal. You cansee that the device is a crescent shape to allow smooth passage through Schlemm’s canal. The outside of the device that you see here is wide open so as not to obstruct or disrupt any collector channel so that when it’s in place, you see this Schlemm’s canal on the lower left, it’s elliptically shaped, it dilates and increases the cross section of that Schlemm’s canal
by about four or five times its natural size, we hope creating access to multiple collector channels.

Very quickly, some of the basic science we’ve done. We’re very passionate about our basic science, I think this characterizes our company. In the upper left you see an image that demonstrates the scaffolding nature of our device in Schlemm’s canal. The image on the right is a collector channel study that demonstrates the number of collector channels that the Hydrus device accesses. The researchers determined, on average, that we access six collector channels. The picture on the lower left is a fluorescein dye study where the researchers were assessing the intensity of
dye in the region of the Hydrus device. You can see here, because it’s scaffolding the canal, you see so much dye in the area of outflow where the device is. In the lower right is a bio-compatibility study where the device was implanted in a synamologous monkey, explanted at three months, and what you see is healthy, porous trabecular tissue. This is a very quick dye injection that we believe demonstrates the scaffolding natures of the device. You see the device there at the top, you’ll see a quick dye injection, this is from Mike Ahmed, you can see the aqueous veins lighting
up. We believe we create immediate communication with the collector system. The proof is in the pudding though, obviously it’s all about evidence based medicine. We have four large randomized control trials ongoing. We have two studies looking at Hydrus plus phaco verses phaco alone in mild and moderate glaucoma.

The study on the left, Hydrus two, is an international study that’s fully enrolled. We have full, 6 month results and we’re now capturing 12 month results, protocol very similar to our US pivotal trial. The study on the right is our pivotal trial. It’s the largest glaucoma study sponsored to date that we’re aware of and that trial is ongoing globally. We also have a couple of comparative effectiveness studies. I think I speak for everybody in the industry on the panel. We’re very hopeful and optimistic that the Glaukos eye stent becomes the gold standard for these sorts of
patients in the coming two years. We’re looking at the Hydrus device in comparison to the Glaukos device in mild to moderate glaucoma with cataract patients. That study is about 50% enrolled now. We also have a study looking at the Hydrus compared to two Glaukos eye stents in phakic eyes so as to eliminate the pressure lowering effect that comes with cataracts surgery. We look forward to the results of these trials as we go forward. Thank you again, it’s an honor to be at this meeting.

Dr. Kerry Solomon: Our next speaker will be Brian Walsh.

Brian Walsh: Thank you very much. My name is Brian Walsh, I’d like to first thank the media organizers and also our esteemed panelists and moderators. We only have a few slides here so I’d like to focus primarily on our flagship technology which is the CyPass Micro Stent. The CyPass Micro Stent is Transcend’s eighth iteration.

It is a micro stent that’s designed specifically to take advantage of the outflow potential of the suprachoroidal space. The CyPass is placed in the supraciliary space, allowing direct flow access from the anterior chamber to the suprachoroidal space for egress of aqueous, lowering IOP. It’s delivered via guide wire controlled delivery system atraumatically through either the cataract incision wound or paracentesis. It is delivered into the ciliary body band before the scleral spur, gliding the stent in place with its guide wire controlled system. On the left is one of our
newest technologies that we’ve developed to facilitate MIGS procedures. You’ll see a CyPass being inserted, the sconeo prism floats on the cornea but also allows the surgeon to control the eye. This has been well received.

The video to the right, if we can click on that, demonstrates a gonio- free approach that has been developed by Transcend. This allows the Transcend CyPass Micro Stent to be delivered in a phako friendly or phako position without movement of the head or the scope. Lastly, Transcend has been focused on building a foundation on good clinical research. We have over 1,000 patients treated to date. The international series that we’ve presented at the last three major ophthalmics symposiums demonstrate an IOP reduction in the 35%-40% range for combo cataract and standalone 25%-30%
IOP reductions with also common reductions in medication use for both groups. I’m also proud to announce that we’ve just completed our US pivotal trial, completed the enrollment of this trial, which is 505 patients in the largest trial of it’s kind to date. Thank you very much.

Tom: Thank you, Brian. I think the congratulations to Tom Burns and Glaukos is well deserved and really I’d like to congratulate all four of these gentlemen and companies, it’s an extraordinary effort that’s underway. It’s disruptive technology and we’ve needed it for a long time. So it’s great to see these guys here. Rick Lewis; So it’s all over? Glaucoma’s cured?

Rick Lewis: I think we’re finally making some good steps forward. Not only is it a safer procedure, but we’re actually attacking the problem where the problem is, which is in the outflow system, as opposed to creating an artificial system that is in high risk for infection. It’s a very exciting time. It’s not just in the glaucoma community that you’re sensing it, but you’re sensing it in the cataract community and across ophthalmology. I think it was five, ten years ago when all of this was evolving. I was skeptical of how this was going to play itself out. I think Glaukos, getting good data, getting their reimbursement piece in place, getting it available, has really opened the doors. That’s what I think has allowed this to take off like that. I think, having been involved in canaloplasty and all of the problems we have with reimbursement, it was a challenge. With the reimbursement piece in place the clinicians can now just attack the disease. It’s an exciting time.

Dr. Kerry Solomon: I’ve got a question for some of the industry folks here. From my standpoint as a cataract guy, not a glaucoma guy, many of my colleagues want to know: Is your technology really going to be well adopted by comprehensive cataract surgeons, is this going to be within their skill set to adopt? And is this going to allow cataract surgeons to treat glaucoma at an earlier stage?

Tom Burns: I’d be happy to take it. In our US commercial lineup we now have several dozen comprehensive ophthalmologists who have done the procedure with really good facility. The nagging initial concern is gonioscopy. Most of these general opthalmologists haven’t done gonioscopy since their residency so there is some facility, some knowledge to be gained as they look at the angle and try to understand some of the markers. Once they do, this is really about a three to five procedure learning curve. It’s what we’ve found in our training, and we do exquisite and intimate training with each of the surgeons, and we’ve done it very selectively in our controlled commercial launch. There’s no question this is going to be adaptable, there’s no question it will be ubiquitous and widespread. I think it will become a standard part of every cataract surgeon’s armamentarium.

Dr. Kerry Solomon: When permitted, do you think it will allow cataract surgeons to start treating this disease in an earlier phase?

Tom Burns: I do. Right now we’re allowed to do it with mild to moderate glaucoma in combination with cataract surgery. I think the rubicon, for me, is the movement of this procedure to phakic and pseudophakic patients. When you look at the numbers up there, with 20% co-morbidity between cataract surgery and glaucoma, there’s 80% of open end glaucoma patients who aren’t undergoing cataract surgery and I think that this will migrate naturally to that phase and to the clinician, provided we get the reimbursement in place.

Dr. Kerry Solomon: So Tom, you think the biggest obstacle with your technology is gonioscopy. How about some of the rest of you? What are your thoughts? Will your technology allow people to treat it earlier and if so what are the biggest obstacles to adoption?

Brian Walsh: Kerry I’d like to mimic Tom’s thoughts. For the comprehensive ophthalmologist and cataract surgeon I think that gonioscopy will be the largest hurdle, considering that, let’s say that gonioscopy is not required in daily practice for the general ophthalmic surgeon. That’s why I think it’s quite important that we not only have good training programs to help the comprehensive ophthalmologist learn how to use gonioscopy, but also move beyond gonioscopy with improved technologies to ultimately get to the holy grail which is the insertion of these devices without the use of gonioscopy. That’s our intention, to move in that direction.

Dr. Kerry
Solomon: Now, Ron, your device doesn’t require gonioscopy.

Ron Bache: It doesn’t require gonioscopy. Surgeons that are good with a gonioscope use it, but because of the destination and the location of entry, it’s a bit more forgiving. We have a bigger area that we’re working with. In addition to that, getting back to your previous question, AqueaSys is focused on – our first step is that 80%, not the 20%. So we’re actually focusing on those patients that have a meaningful need to lower their IOP, whether they have or do not have cataract surgery, and we think cataract surgeons will adopt technologies that are safe, effective, and easy to do
and are provided reimbursement. Our focus is actually more on the 80% than the 20%.

Dr. Kerry Solomon: Great.

Dave Van Meter: Kerry I would echo also what Tom Burns said. Ike and I had an opportunity to go down to Honduras with a couple of cataract surgeons who hadn’t done really any angle work since their residency. We brought Ike along to sort of be the belt and suspenders of the whole situation. We got there and a few cases in both of these guys picked it up pretty quickly. About Ike, about halfway through the first day said, “You guys didn’t even need me here,” so we were very encouraged. I think the cataract surgeons are extremely skilled. There’s this perception that the glaucoma doctors
are the ones who know their way around the angle, and they do, but there’s a skill set with the cataract surgeon that clearly can take these technologies on.

Dr. Kerry Solomon: Ike, has that been your experience? You’ve got lots of folks I know that come watch and observe gonioscopy.

Ike: Yeah, I agree. I think that the gonioscopy piece of it, we probably underestimate that surgeons are quite comfortable moving toward that. Cataract surgeons are already, I mean yourself being one, are very comfortable working in the anterior chamber.

Dr. Kerry Solomon: Some of us are comfortable in the vitreous, but anyway.

Ike: Most of the time we’re in the anterior chamber. I think the skill set actually, in some ways, you could argue that the cataract surgeon may be more skillful at doing some of these things than traditional glaucoma surgeon who’s working outside the eye and not using the kind of dexterity requirements in the anterior chamber. I personally don’t have any issues. I train residents and fellows on the eye stent, it’s been approved in Canada. They’ll pick it up, they’ll go and use it and they’re all doing quite well with it, so I feel very comfortable with that approach. There are advantages with all of the different approaches and I think that this is an example where we have implant technology but we’re going to see further innovation in visualization and guidance and implanting. Just as we’ve seen with cataract surgery or refractive surgery. We’re going to improve the precision of these procedures, I think we’re just seeing it start now.

Tom: Ike and Rick, and for the audience in general, you can easily categorize these procedures by where the fluid goes. Ike showed the slide of where the reservoir for outflow is for each of these procedures. It’s a really critical point. An oculophysiologist could say pros and cons of each of these. Ike and Rick, Ike you first, what’s the single most appealing thing about the canal as a reservoir, the suprachoroidal space as a reservoir, and the subconjunctival space and what’s the most concerning thing about each of those as well? Just one thing on each side of the equation.

Ike: Good question Tom. We’ve had a lot of experience with all of these devices and they all have theoretical value and concerns and they all have practical results. When you look at these, and I had a slide on that that kind of compares the different devices, as we have more data coming out I think it will be helpful to do those comparisons. As I said before, the canal is a physiologic target. It’s a target I think is very safe, the safety of the procedure, I think, is unparalleled. I really value the safety being in the canal and I really enjoy being there because that is truly a physiologic outflow. At the same time, it’s probably technically the more challenging one we’ve talked about, in terms of getting the devices in place, and I think, training, that’s where further device technology is going to allow an easier implantation technique that will help. Most people’s hands though, I’ve seen, with training, they get around that. And of course we also have a bit of a floor. We have the episcleral floor, which is actually protecting us from hypotony, which is a big concern with traditional surgeries, but also limits the effectiveness in
terms of “How low can we go?” But again, for the patients we’re talking about, these targets I think are quite good.

Suprachoroidal has a vast resorp [sounds like 26:37] to potential and the suprachoroidal space is fairly easy to use, it can be gonial free as well. So I think it has a lot of value from that perspective, and it’s a very straight forward procedure. The suprachoroidal space is one of those unknowns. It keeps aqueous internally as well. We don’t know a lot about uveoscleral outflow, as much as we’d like to. We don’t know how things behave in areas in those spaces and that is why I think this is the unknown, but so far what we’ve seen has been very promising. And the subconjuctival, last, clearly very potent. I think approaching it from an ab interno way enhances the safety and the characteristics of the procedure. Potency I think is positive. I think we also have to think about
how things happen outside the eye or around the eye in terms of the differences. They all have pros and cons. I look at these as perhaps something that, for a lifetime of a patient, we may be using one MIGS device and then later on maybe another MIGS device to add to it. The beauty of all of these is that they don’t, like other procedures, effect the result of what the next set will be, which I think is a real valuable mix.

Rick Lewis: Was that just one answer you were supposed to give or is that multiple?

Ike: I should have had Rick first.

Rick Lewis: I think Ike is always a tough act to follow, but I think that the one piece that wasn’t discussed is the fact that when we’re talking about glaucoma, we’re not just talking about open angle glaucoma. In fact, the biggest problem in Asia, in China, is angle closure glaucoma, and that’s where these canal based procedures are not going to work because we can’t get access to the canal. I think the good thing about these is we have procedures that will work in open angle and we have the AqueSys procedure that will work in all of these procedures. There’s a variety of
different approaches now other than what we had for many years which was trabeculectomy. So we now have a spectrum of options which are great.

Dr. Kerry Solomon: It seems to me that these devices are somewhat additive? Would you agree Ike? If your patient doesn’t get a good enough result with one you could move to a different space or a different type of procedure?

Ike: I think theoretically that’s a tremendous value. To direct aqueous to different spaces where they may be in whatever order is something we haven’t fully uncovered yet, I think maybe we have potential.

Dr. Kerry Solomon: From my standpoint as a cataract surgeon, one of the things that would be a deal breaker for me is it slows me down in the operating room or as an owner of a surgery center, if it’s going to tie up a lot of time and create a lot of inefficiencies in the system. I’ve been incredibly surprised, having no experience with gonioscopy, how quickly I was able to pick it up. All of my partners and surgeons at our facility, it’s been very efficient, it’s been very effective. It seems like the rest of the devices that I saw presented, all are similar. I don’t know if Rick or Ike want to address that, I don’t know if you have more experience.

Rick Lewis: I think you hit the nail on the head. Again, assuming an open angle, I think that all of these devices have a huge role. It will be very interesting when we get comparative trials, to compare one of the devices against another one or a couple of devices verses each other. There’s so much opportunity to see what’s the maximal pressure reduction. If we could titrate pressure reduction down to a specific level, to a custom level, we’d probably be able to control this disease effectively.

Ike: There’s a tremendous amount of learning just as we’re using these devices. We’re talking about pivotal trials, being able to build on that and learn what their roles are I think is really a great interest. I think there’s vast potential here, we’re just scratching the surface. Clearly, in my practice, there’s no question on how it’s changed things. Completely different as far as what we were doing five or six years ago. I think we need to go through the right steps, the right studies, the right basic science and analytical work, but it’s very,very promising.

Tom: Ike, to that point, Ike’s practice in Canada is what ours might look like in several years because he’s got the capability of putting more than one eye stent in, he can put in a Hydrus if he wants, he can put in a suprachoroidal device if he wants. So, Ike, with all of those options available, in what circumstance are you doing a traditional trabeculectomy, for example, as your initial surgical incisional glaucoma procedure? Or does everyone get a MIGS prior to going onto a more traditional approach?

Ike: It’s like the war of 1812 all over again! Canada’s taken over again. Traditional surgery, looking through numbers over ten years, has gone down 90%. It was going down already. But in my practice it’s gone down tremendously. In fact, we have such trouble training our fellows in residence on trabeculectomy now because of these other options. It’s a real problem in training. That’s how it has affected our practice. We are a bit outliers, we’re doing our procedures in phakic eyes, with all of these devices we’re doing them in pseudophakic eyes as part of studies. We’re doing them in advanced patients as well in these categories. It has completely changed how we look at patients, and completely changed how patients look at surgery as well. It has been that exciting. In temper, of
course, obviously we need the proper data, we need long term results and everything else. Very important, in glaucoma more important than other diseases which is chronic here. It has completely turned it around in terms of how we approach surgery.

Rick Lewis: I think that Ike hit the nail on the head. It is a complete time set [sounds like 31:47] different approaches to glaucoma surgery. It’s eliminated so much of the risk factor. I think the key issue here is: When are we as clinicians here going to be comfortable with doing this instead of medications? At what point will we find that treating this and getting rid of the compliance problems and all of the inherent problems of applying eye drops, as Gill mentioned, these arthritic hands trying to put drops in, at what point are we going to be able to do a mixed procedure before we do medication?

Tom: That’s an excellent question, it was on my list to ask you all. I think what needs to happen first, and Tom Burns alluded to this, is that this next agenda is to try and get approval for phakic eyes or for multiple stents. So Tom, can you give us a prediction of when we might be able to use these technologies that maybe are not on the current label?

Tom Burns: What I would say to that is we’re currently looking and we’ll need to discuss with the FDA approaches to the use of these MIG devices and phakic and pseudophakic eyes. Independent of that, we’re currently doing 18 clinical studies. We have over 4,000 patients enrolled in pan-european studies, studies in Armenia and in the States, to hopefully show and evaluate the safety and efficacy of these MIGS devices across the whole span of patients, phakic and pseudophakic. When we have that data, and it’s presented in a form of peer reviewed studies, those studies will be made available to payers. Once they have those studies in place and medical necessities established we’ll provide the discretion to be able to cover for these types of procedures. And you know as well as I do, Tom, that once the coverage is in place and the performance has been validated through long term clinical studies, these procedures will migrate to the phakic and pseudophakic patients independent of any approval process.

Dr. Kerry Solomon: Well, Tom, as a cataract guy, we really do want to thank you for establishing the space, and for all our industry folks: Keep working hard. It’s important and we need better tools. On a personal level I want to thank Ike and Rick and Tom because you guys are teaching us really important things that we need to provide the tools that we can to our patients. Thank you.

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