The Exciting Evolution of MIGS Procedures

Gary Wörtz, MD, asks Ike Ahmed, MD, to share his thoughts on technologies in the pipeline for microinvasive glaucoma surgery (MIGS). Dr. Ahmed provides an overview of surgical techniques and procedures to help alleviate potential uncertainty with these new devices. John Berdahl, MD, also shares his perspective on the exciting state of MIGS innovations.

Gary Wörtz, MD: Open. Outspoken. It's Ophthalmology off the Grid, an honest look at controversial topics in the field. I'm Gary Wörtz.

MIGS—microinvasive glaucoma surgery. It's really sparked a revolution in the glaucoma space, and it continues to evolve and disrupt the ways in which the condition is treated. So, there's no better place to begin a discussion on this approach than with Dr. Ike Ahmed, a pioneer in the MIGS movement.

Ike Ahmed, MD: We've been working on MIGS for over 10 years, and we've come to the point now where we actually, I think, have had a lot of success on the ground now thanks to availability of devices like the iStent and newer devices.

Gary: Later, I'll speak to another MIGS leader, Dr. John Berdahl, about his involvement in the evolution of this category.

John Berdahl, MD: It's made a real difference in how we take care of patients. For me, the thing that I am most excited about that's happened over the last 5 years or since I've been in my career.

Gary: Listen in, it's going to be a great episode.

Speaker 4: Ophthalmology off the Grid is supported by Ilevro from Alcon.

Gary: Today I have Ike Ahmed with me, and it's kind of like talking to a legend. The man, the myth, the legend: Ike Ahmed. He wouldn't say that about himself, obviously. He's such a humble guy, but everyone who knows Ike or has heard him speak or has got a chance to watch him operate would say this guy is just on the next level. Ike, with that being said, thank you so much for taking a small slice of your evening and talking to me about where MIGS ... where we find ourselves with MIGS, where it's at, where it's going, and maybe where we fit the different tools that are coming out in to our tool bag. Thanks so much for taking a little bit of time to talk to us tonight.

Ike: No, thank you Gary. It's great to be here, and thank you for putting together the series. One of the great things we do in our professional life is work with great people and be able to put our minds together and think about new plans for our patients, innovate ... I mean this is what it's about. Working together with you and others has been a great experience. If I can share something to the group and the audience I am happy to do that, so thanks for having me here, Gary.

Gary: Yeah, absolutely. The iStent is now a device that really has found its place in the marketplace with comprehensive ophthalmologists and cataract surgeons embracing it. Patients seem to be getting good results, maybe even results that are better than what we initially thought in the FDA trial. At least that's what I am kind of hearing, word on the street. As iStent came in the door and opened up this channel, where do you see the current state of things with iStent? Then walk me through your thoughts on some of the other devices that are going to be coming out hopefully in the near future, such as the CyPass, which will be now developed through Alcon, and then the Xen, which is an Allergan acquisition.

Ike: It's been an amazing transition as we move toward interventional glaucoma, and this is kind of where MIGS and iStent and these other devices fit really well in that. I think we're still kind of going through that period of learning as far as understanding what roles these have. We've been working on MIGS for over 10 years, and we're cut to the point now where we actually have had a lot of success on the ground now, thanks to availability of devices like the iStent and newer devices. It's also created a bit of a crowded market now where we see a lot of new devices coming on the horizon, or that are here, and certainly it does give us excitement, but it also adds some element on uncertainty as far as where they fit.

A couple things on MIGS that we realize is that we've taken glaucoma surgery, which has traditionally been a last resort and a high-risk procedure, although albeit pretty profound with pressure lowering, and moved it in to a procedure that is very safe and that can be done with cataract surgery. The recovery and the safety approach is that of the cataract surgery level. So it has really allowed us to really open the door to a whole generation of patients that otherwise wouldn't be candidates for intervention. I think that is probably the biggest thing that we've seen, is the indications have changed as far as moving into the surgical space in glaucoma.

And iStent certainly led the way with the first MIGS device being approved in the US and is a device which has the ultimate safety value of being in the canal. When we look at the canal, I like to kind of look at things both stenting, as well as cutting techniques, as well as ablative techniques. Whether trabectome with ablation or whether it's cutting techniques like goniotomy techniques. And now we see again a variety of devices like the Kahook Dual Blade from New World, like the visco with trab 360 procedures, and the ab interno GATT procedure, and the ABIC, ab interno canaloplasty procedures. All these procedures are essentially enhancing flow through the natural drainage system. I think they all have a great value of safety, and I think there are going to be some differences we start seeing with efficacy and perhaps some of the safety parts and other things, but I think it's still early to know those differences. I think the results can be seen with the numbers, and the numbers speak for themselves. I think that when surgeons see a patient going to cataract surgery that has glaucoma or has glaucoma medications that we take the opportunity to, why not, treat with a procedure like MIGS that can get them on less medications or off medications at a higher propensity than doing cataract surgery alone.

So that is the first thing I think would maybe exist. I think that surgeons are becoming comfortable and understanding the role of MIGS, specifically with the cataract patient. We will talk later, perhaps, but that certainly is not the end of MIGS. I mean, MIGS is certainly much bigger than that, but I think that's where we are excited to see where the market goes with other devices and also stand alone devices as well. I think that is what I would say as far as MIGS and iStent. You mentioned some other procedures. I'm happy to maybe talk about where we are going with other procedures if you would like me to move in to that.

Gary: Well, let's stay where we're at right now because you brought up some interesting points. It seems like the older surgeries we had a procedure that was highly efficacious and, in many times, overly efficacious. You really dropped the pressure maybe even beyond where you needed it, but the safety profile was really not what we wanted. That's why, as a cataract guy, I was really happy to always just anyone I felt needed a trab or a tube, some higher level intervention, I was happy to send those patients on to my favorite glaucoma specialist. Now it seems like maybe what we are trying to do is change the balance point a little bit. We're increasing safety. In some ways I think you can make the argument that the efficacy of these procedures obviously is not quite as good as a shunt, but the people that we're treating with these don't necessarily need that pressure reduction all the way down to what a trab or a tube would provide. In those cases, I think we're trying to match the patient population to the efficacy of the procedure while maintaining a high level of safety. Does that resonate?

Ike: Yeah, I think you said it very well, Gary. I think the mistake we sometimes make, and I know in our glaucoma circles sometimes we have these debates, is trying to compare these procedures to the "gold standard," which is trabeculectomy. Like you said, this is a different patient population we're trying to treat here. I think that's important to differentiate when we talk about procedures we look at the risk, the reward, and the effort. These procedures truly fit a different level. I think one of the weaknesses of these procedures, as you mentioned, has been questions of efficacy. The FDA trial, for example, with the iStent was not a very significant, big difference. It was significant statistically, but it was not as much as we were expecting to get compared to phaco alone, which of course does lower pressure.

I think one thing we've realized as we've gotten better and more proficient with the procedure, for example tapping in to the right episcleral veins, targeting procedures to the right place, putting in more than one particularly outside the US, for example, I think we're seeing that we're getting more efficacy. I think, just like we've seen with the procedures ... even phaco and VR surgery and refractive surgery. If we hung our hat on the first experience that people had with these procedures, we wouldn't be where we're at today. It's really thanks to the many surgeons that are evolving with the procedure, that are learning to maximize efficacy, picking the right patients are important, that we're really finding a sweet spot. I think we're finding a really good sweet spot because of the safety value. I am very convinced looking at our data and others’ data that these procedures do work, they do lower pressure. But they're not just simply go, point, shoot randomly at anybody and expect them to work as well as planning carefully and the art of the surgery that's important in that. That's the message I'd also like to add to that. Again, understand that there's a different need, it’s a different patient population that we're looking at. Like you said, Gary, these are patients that don't need low targets, the patients that we're looking at getting off medications. Medications and compliance is a big issue that we don't really understand well. We don't really recognize it enough and yet it has a bearing on progression as we've seen in some recent studies. That's the kind of target we're looking at. Again, it is really a patient population that is well suited among comprehensive cataract surgeons. I'm really happy that I think glaucoma truly is something that is part of most comprehensive ophthalmologists’ practices. Right?

Gary: Right.

Ike: Folks out there that do comprehensive ophthalmology up to 34% of their patients that walk in have glaucoma. So there is no better person to treat those patients than their treating ophthalmologist. Now there are tools that allow them to do that. And believe me, there will still be enough business for the glaucoma guys because we still need patients who need low targets, who are going to need to have surgery, and need extra care.

Gary: With that being said, that's a perfect segue in to the next level of MIGS. As we've stated, the goal of putting in an iStent is not necessarily as a procedure to take the place of a trab. As we've said, this is really for those mild to moderate patients who are trying to get off maybe a med, maybe another med, or just increase their compliance overall with an overall lower pressure.

Walk me through the devices that you see on the horizon that may have the chance of actually supplanting trab or tube for those patients who are past the mild stage, maybe more in the moderate phase, maybe in the severe phase or patients who simply are just very noncompliant and you see progression and you're worried about them. Those are the patients who, maybe they're not all the way cupped out, but you see patients progressing and they're not taking their meds—those are patients I worry about. So walk me through the next level of treatment or level of care, which in my mind would be going to the suprachoroidal space and looking at the CyPass or maybe even with the procedure that Allergan is developing with the Xen. Walk me through where you feel like those might fit and sort of the pluses and minuses of those techniques.

Ike: I think there's a lot of excitement now, particularly with the couple of strategics, Alcon and Allergan, now getting in to this space because that really exponentially increases the size of the interest. A couple things on this point here. I like talking about MIGS as these procedures that are safe, they're ab interno delivered typically, and they're quite efficient procedures to do. Internal MIGS, meaning internal drainage procedures that are like iStent, which are canal-based, and now CyPass, which is suprachoroidal-based, are internal drainage procures. So I call them internal MIGS. Procedures like the Xen, which I still consider MIGS because it's ab interno, it has some safety value compared to other procedures, but it is external drainage, that's kind of sort of a MIGS plus, as I call it, where you get plus ... you get additional IOP lowering but it does come at some cost in terms of creating a bleb, and some extra maintenance required postoperatively, and some additional risk you take by creating an external bleb. This does, again, maybe complicate things a little bit, but it does help me to kind of differentiate the internal MIGS devices from MIGS plus.

Internal MIGS—suprachoroidal devices—is the new kid on the block. The FDA studies are being submitted and reviewed. This procedure takes potential advantage of the suprachoroidal space. So far the work that has been done with the CyPass has been predominately done with phaco, and when we look at the data that has come out—from, for example, the Compass trial which was presented recently at ASCRS and has been submitted for publication, a big 500 patient study, watching all patients before treatment and after treatment as well—did find a pretty good delta between those that had phaco plus CyPass versus phaco alone. Now, still not to the level of a trabeculectomy or a bleb forming procedure externally, so I will caution those on that point. But it does seem to have good safety like MIGS procedures do, and we will have to see again where it fits in versus the iStent and versus canal-based procedures. I think we still don't know. We don't have any good head test studies to compare.

My feeling is we're probably going to find that the suprachoroidal space will have a need for certain patients and the canal will have a certain need for other patients. That may be differentiated based on safety, based on technical ease of delivery, based on number of devices that may have to be used, and efficacy, of course. I think we're still not quite there to know it, but I will say I think with CyPass, I think we're not necessarily going to get to the level of a trab. Now, that being said, we are doing some exciting work looking at augmenting suprachoroidal procedures with, for example, visco expansion. We're injecting viscoelastic in the suprachoroidal space to enhance the space around the implant at least for the first few weeks of the important postoperative healing period. That seems to create a bigger lake in the suprachoroidal space long term, which may actually further drive pressures lower to hit targets that are more in the trab population. We are pretty excited about that.

Gary: Wow.

Ike: It's still early on that. I am actively involved in that, but that may actually help us to push these pressures lower. Lets not forget about trabs. If we didn't have mitomycin and we didn't have 5-FU, we would not be able to hit pressures of 8 to 10 consistently. Right?

Gary: Right.

Ike: We would be getting pressures in the mid teens to high teens, which is what we're getting actually with MIGS. Trabs do have an advantage, and we have the antimetabolite. For these MIGS procedures, we don't have the antimetabolite. We're not comfortable using mitomycin in the eye. I think time will tell. We are going to hopefully be able to use adjunctive wound healing modulation to help us drive pressures lower. We're not there yet. Visco expansion may help us with that. For now at least, if we want to get to trab levels of pressure lowering for certain patients that need them, then we're going subconj, and that means the Xen delivered ab interno allows us to create a bleb, puts pressures and reductions which are getting close to trabs, we need more data on this one. I think that's where we have that niche that's basically been developed for that patient population. We're also finding that because of the ease of delivery and the safety, that surgeons are willing to use Xen earlier too, mind you. This is going to be an interesting discussion about where Xen fits compared to some of the other options because Xen may be able to be used earlier because we are happier with the safety profile. That's still to be determined. For all intents and purposes, for now at least, it's a procedure that is certainly in the wheelhouse of a glaucoma surgeon. There are going to be some cataract surgeons that are comfortable managing blebs and may venture into this area initially as well. Others may be more interested as time goes on and they realize and see that these blebs are easier to manage than trab blebs. That will have to be shown first and foremost.

Then the other new kid on the block is InnFocus, which is becoming perhaps the most potent pressure-lowering new glaucoma procedure that I think really has a real chance to replace trabs, but is a procedure that does require us to do an ab externo approach, meaning we open up the conj and place the device. Again, we are currently doing studies, very pleased with the results of that procedure as well in terms of pressure lowering. Again, that's in the wheelhouse of a glaucoma surgeon. Really, trab is becoming, in my opinion, less and less commonly performed in our practice because we have better options to do procedures that are post-trabs or alternatives to trabs or pre-trabs, whichever way we go.

One point I want to make is the pivot point for me is whether or not the patient is going for cataract. If we have to book for cataract surgery, then I really try to go internal, meaning canal-based or suprachoroidal procedures, as opposed to doing trabs or blebs if we can avoid it because we know that creating blebs and doing phaco sometimes work against each other. Phaco creates inflammation, sometimes blebs are harder to manage, but yet with the canal-based procedures or suprachoroidal procedures it seems to be a good synergy with phaco. Often what I will do is, if I do a patient who likely needs to have a bleb, I will still go ahead and do phaco plus MIGS, internal MIGS, and I will tell a patient, "Listen, we may have to go do a procedure that's subconj-based later on, but I will separate it up by a few months." I think if I have to go bleb, I am going to be better off waiting a few months, blood-aqueous barrier stabilizes, and then go subconj, but there's a good chance that I may not even have to go there if my phaco-MIGS works well enough and we may be okay with this.

That's kind of where I'm at now. One of the pivot points again is phaco or no. When we have to do a standalone procedure, I am usually going subconj because so far the canal procedures and the suprachoroidal procedures are not enough typically to treat a patient that's progressing, that needs a standalone procedure to get low enough.

Gary: That makes a lot of sense, Ike. You're already going to be in there, you might as well do what you can to help the patient. You're not burning the bridge of potentially doing a conjunctival-based procedure. It's really kind of a, "Hey, let's do what we can do. Let's manage this the best we can. Hopefully we can save you from having another surgery." Patients are very appreciative when you can offer something like that. A good friend of mine, John Kitchens, who you may know, is a great retina surgeon here in Lexington, Kentucky as well. He and I performed a lot of surgery in tandem, where I will do cataract surgery and then he will go ahead and do whatever vitreoretinal surgery needs to be done. Patients really are appreciative of the fact that they can have both their cataract and their retinal procedure done at the same time. I feel like that's probably a very similar situation.

Well, Ike, thank you so much. I know you're busy and you've got other things to attend to. Thank you for taking some time tonight, talking to us about MIGS, viving us a little bit of a break down of where they fit in to your practice, how you look at the landscape, and how you sort of decide and decipher which procedure might be working best for which patient population. As always, look forward to maybe seeing you at one of the next meetings.

Ike: Well, thanks Gary. I hope that was helpful. I think glaucoma is really going under a renaissance. Interventional glaucoma is how I like to say it. Whether it's MIGS devices or drug delivery, diagnostics … we're really going to be undergoing a renaissance. Again, it's a pleasure to be able to work with a team of folks, including yourself, to kind of help to understand these better. Thank you for having me here and, again, I wish everyone luck in helping our patients to get better outcomes.

Gary: Thanks a lot, Ike. Take care.

Multiple innovations have come to market, and a number continue to move through the pipeline. One of the surgeons who has contributed his ideas and insight to the process is Dr. John Berdahl. I had the chance to catch up with John and to hear a little bit more about his experience and what excites him most about these new procedures.

Today we have John Berdahl back with us for another episode of Ophthalmology off the Grid. John, I wanted to just say thank you for taking another bit of your time to give us some perspective on MIGS. This is a space that has really been exploding, at least in terms of the devices that are in development. I want to get your take on where you see MIGS right now, where you see MIGS going in the future, and which patients might benefit from which strategy or which type of technology. Maybe we will just start off by you giving us a little bit of background on your experience with iStent. I know that's something that you really were early on with. From there we will go on to some of the other things that have come out and things that are coming out in the future.

John: Yeah, you bet. Thanks, Gary. Great job with Off the Grid. I love it and I love the things that I learn from it.

MIGS, which stands for microinvasive glaucoma surgery or minimally invasive glaucoma surgery, either one, is a new category and it's made a real difference in how we take care of patients. For me, it is the thing I am most excited about that's happened over the last 5 years or since I've been in my career. It fills in a gap that nothing else really fills in that well.

Real quick, my experience with it is when the iStent was approved, we started using that right away. Previous to that, I was in the generation 2 Glaukos iStent trial, what they're calling iStent Inject, that is kind of two little rivets that get put in to the trabecular meshwork. Then I am in a suprachoroidal stent study right now. I was in AqueSys study, so I've got experience with that as well. It's exciting to see that things are going to be evolving in to potentially combined MIGS plus drug delivery.

In the meantime, with iStent kind of being the first MIGS implantable device that's out there, there is kind of some innovation on ideas that we've long thought maybe weren't going to work. Things like the Kahook Dual Blade, which is a trabecular meshwork excision. Some of the other trabecular meshwork procedures that are out there. It is really nice to not have to go from medications to trabeculectomy, and there was big space to fill and these devices fill it well.

G. Wortz, MD: Let's kind of walk stepwise through your thinking when you're seeing a cataract patient, so someone has a cataract and they're coming in. It's time for surgery and maybe they're in that mild to moderate category, maybe they're on one to two meds, maybe actually fairly well controlled, maybe they've had the SLT, and you now have the one opportunity of this patient's lifetime, perhaps, to do something even though it may be invasive, it is minimally invasive. Walk me through your conversation with someone about having not only cataract surgery but, in this case, either doing the Kahook Dual Blade technology where you're excising a strip of TM or an iStent or maybe combing those for patients who have a little, maybe they're on two or three or more meds.

John: The kind of mild to moderate plus cataract is kind of the bread and butter and more less slam-dunk patient, at least for me, in terms of thinking on what's the right thing to do. The right thing to do is to take that cataract out and do a MIGS procedure like an iStent or maybe a KDB, which stands for Kahook Dual Blade.

Let me just walk you through the conversation I have with the patient. It goes something like this: "Hey, you've got a cataract, and if we take your cataract out, we're going to make you see a lot better. You've also got glaucoma, and while we're in there doing your cataract surgery, we can put a little device in to help protect you from your glaucoma, lower your IOP hopefully, and hopefully even get you off medication. That's what I think we really should do for you, and when we do cataract surgery, you've got options for your vision after. So, if you hope to wear glasses, no problem; we will take a standard approach. If you have hopes to not wear glasses for distance much, we may have an option for that. If you're hoping to not have to wear glasses for distance and up close, we've got an option for that." Now, those last two things cost extra, and we will talk about prices. To me, if you've got mild glaucoma and you've got a cataract, for me, it is a foregone conclusion that MIGS device makes sense because they're just as safe as the cataract surgery and they're only going to really help you.

Gary: John, one of the reasons I like talking to you about this is that there are some guys who talk the talk and there are guys who walk the walk, and I put you in both of those categories. You're out there talking about a lot of devices, but you're a busy practitioner, you're a busy surgeon, you're a guy who is really doing things, and I know you wouldn't waste your time and your effort or patients' time and effort doing things that aren't going to be efficacious. When you're doing these procedures, just in your experience, what kind of results are you getting? That's the biggest question I have. Are we doing this because it's approved and it might help? Honestly, I was not overwhelmed by the data from the FDA study, but what I am hearing from a lot of people is they're actually getting way better results than they got in the FDA study. Maybe that's because people are actually getting better at placing the iStent. Walk me through what your experience has been. Real-world results. Do most patients get off at least one drop if you give an iStent?

John: Really good question, Gary. Tongue-in-cheek people would call this minimally effective glaucoma surgery, and that is really clever, but I think it's inaccurate. We've got the largest series published, and we're submitting it for publication in a peer-review journal. We published it at ASCRS. Three hundred and sixty patients with up to 2 years follow-up time, so a really large data series. In combination with cataract surgery, one stent. What we found is that the average IOP lowering was about 4 mm Hg. That's consistent with what was in other trials. Average medication reduction was roughly 50%. That's interesting and that's efficacious. People would say, "Well, maybe it's just the cataract. Cataract lowers IOP, too." We also studied it in pseudophakes. So, you had a comment earlier on that it's their one chance to get MIGS—it's actually not. I think that the companies have done themselves a disservice by saying you can't do it in pseudophakic patients. That's incorrect, because you can.

We're allowed to do things off-label; it just may or may not get reimbursed, but remember reimbursement isn't tied to labeling. Things that are unlabeled may not get reimbursement, and things that are off-label may. We've had good luck in our practice getting it reimbursed, but ultimately our job as doctors is to do what's in the best interest of the patient. Going back to the data, in our pseudophakic data, we actually showed a little more IOP drop. A little north of 4, like 4.2 or something like that, in our pseudophakic data compared to our cataract plus iStent data. Why would we see that? The answer is that the preoperative IOPs were higher in the pseudophakic group than they were the cataract group. Going to the cataract group, preoperative IOPs were 19. Postoperative IOP was 15. Fifteen is pretty healthy, a pretty nice place to be. When you broke it out based on preoperative IOP, what we found was that if people were 17 or under, we would get an average IOP drop of about 1.5 mm Hg. If they were 17 to 21, where most people were, we would get about 4 mm Hg. Twenty one to 26, we would get about 8 to 9 mm Hg. Greater than 27, we got an average IOP drop of 14 mm Hg.

Gary: Wow.

John: Right. We were surprised, too. This is really similar to Ray Brown's data. Almost identical to what Ray Brown looked at. The point there is that when you need a MIGS procedure, the more you need it, the better it works.

Gary: So, you are actually getting a graduated response, where higher pressure gives you a higher reduction.

John: That's right, and that makes sense because it is probably the resistance to outflow in that situation is probably across the trabecular meshwork.

Gary: Right.

John: So you're going to force fluid through that little hole better.

Gary: That brings up an interesting point. If that's the place where we say, that's really the bottleneck, so to speak, that actually gives me a lot of reasons to maybe try the Kahook Dual Blade. Tell me a little bit about that. Basically, you're deroofing the trabecular meshwork, is that correct?

John: Yeah, right. Malik Kahook is a friend and one of the most inventive guys that I know. You're up there, too, Gary. Malik, he has ideas and he executes on them, and he has this nifty little idea that says, "If we unroof the trabecular meshwork, maybe we can lower IOP." And one of the advantages that Malik has at the University of Colorado is that he studies that in the cadaver lab and can fashion and try some of these things. We all were taught that goniotomy was a surgery for kids.

Gary: Right. Congenital glaucoma.

John: Right. No, thank you. God bless the people that take care of that, they already have a foot in Heaven. He challenged the existing thinking in the traditional dog run. The results from the trabectome haven't been that compelling. He said, "Well, maybe it's because that's going to induce some scarring, and it's going to leave these leaflets of trabecular meshwork that could cover the ostia of the collector channels." So his design, and why it's a dual blade, is that it's got … think of it like a wedge with a blade on each side of that wedge. So it lifts the trabecular meshwork off, and instead of incising it, it excises it and allows access to the trabecular meshwork channels. I've used it, and it works. I think that it's a really nice complement to iStent or an alternative to iStent in a situation, particularly if you may be worried about a reimbursement situation in a pseudophakic state with something like an iStent. I think that it plays a meaningful role and a great tool in our tool kit to complement the other MIGS devices that are out there.

Gary: I think that, to be honest, that's one of those devices that, you kind of think, "Wow, that's so simple. Why didn't someone think of that sooner?" Those are the really good ideas. The ones that are simple, fairly easy to implement. I think about this like the old Gillette lift and cut commercial. You're basically just lifting and cutting it out and when you don't have the tissue that's there it can't fibrose and, like you said, cause some scarring or blockage of the collector channels. I think that makes all the sense in the world and I would agree with you, Malik is just one of those guys that's on the next level. Someone who is just doing a great job in all sorts of things. I think that's the technology we all need to keep our eyes on. Beyond that, it looks like there's some other really shining stars coming down the pipe. We've got the Transcend CyPass, which Alcon has recently acquired. We also have the AqueSys Xen, which Allergan has acquired. Give me a little bit of your feelings on these technologies. Are these for the average cataract patient with glaucoma or, in my mind, maybe these are for patients with more of a moderate to severe glaucoma who need a higher pressure reduction? What are your thoughts on that?

John: My first thought is that I love Yogi Berra who said, "Predicting the future is easy and being right is hard." So, I will give you my prediction, but we will see if I am right. I think that there's a lot of things here at play, and I have done a lot of suprachoroidal stents as part of studies. They're a very doable procedure, and I think that it's well within the realm of a comprehensive cataract surgeon. I think that the word suprachoroidal scares us all, because it doesn't conjure up good feelings in our heart, but it's really a straightforward procedure to do. My prediction is that folks will feel more comfortable in the trabecular meshwork than they are in the suprachoroidal space and as long as trabecular meshwork procedures like iStent KDB, iStent inject, are available and as easy to do if not easier, surgeons will probably gravitate there unless there's really superior efficacy that is shown by suprachoroidal stents. My prediction would be that the majority of first line MIGS procedures are still going to be at the trabecular meshwork and that suprachoroidal devices will be an adjunct to them. Maybe you've got more severe glaucoma so at the time of cataract surgery you're going to put in a trabecular stent and a suprachoroidal stent. Or you did a trabecular stent and cataract surgery and you didn't get what you were hoping for so you come back and put in a suprachoroidal stent.

Gary: I gotcha—almost like a secondary phase for getting your target.

John: Yeah, that's my prediction. That will be most of the market for that, but I could be wrong. It could be that people say, "No, this is easier to do." Or, "It lowers eye pressure more consistently." But my prediction is that it will be more of a step up in therapy.

Gary: Got you. Then would you say that the same thing is true with the AqueSys Xen? That that may be even the next phase beyond the suprachoroidal devices?

John: That's kind of what I think. One of the nice things about it is that you don't necessarily have to be able to do gonio to do it. You can do it without gonio. and it's probably going to get the pressures the lowest of all of them. As long as the safety is there I think that it has a real opportunity. I really do believe that tubes and trabs are dying, and I hope that they're dying.

Gary: They need to die! Please, let them die.

John: Will some company please kill them?

Gary: Yes.

John: I think that AqueSys really is the one that's going to hopefully put the ...

Gary: The nail in the coffin?

John: Yeah, and I think that it really can lower pressure very effectively. So, that is how I see that role-playing. So all these will be on a spectrum. The nice thing is they're all combinable.

Gary: Right.

John: So, if the trabecular meshwork stent didn't do it, add a suprachoroidal stent. If that still didn't do it, add a subconjunctival stent like the Xen device. We're not giving up real estate and going down a road we can't retreat from.

Gary: Right. Well, you know, this is an area that I've been considering diving into. Anytime you're in a practice with a lot of partners and a lot of other stakeholders, you kind of have to make sure that you're taking your time and not diving in too soon. This is a technology that I really feel like is something that has legs. At first I wasn't really sure. Where's this going? Is it really something that we can do but maybe is not effective? Honestly, the more I talk to guys like you and Bill Wiley and some other folks, I am really encouraged by the efficacy that these procedures are promising and what they're really delivering on.

John: Gary, I want to just challenge you and others surgeons on that just a little bit. I believe that we're called to do the right thing for the patients, provide them with their options. If you see a patient that has cataracts and is on a glaucoma medication, and you have somebody else in your practice that is your glaucoma person and you don't want to step on their shoes, I would ask you or surgeons to say, "Am I offering them to go and get the opinion about MIGS? Or am I just going to do their cataract surgery anyway and keep them on their drops?" I don't want to be soap boxy here at all, but I do think that we're doing the best thing for them by giving them those options. So, if you say, "Hey, you know what, MIGS isn't for me." That's cool, but if you're evaluating somebody that's on cataract and a medication, I would really challenge you to say, "I need to get them to somebody that will at least discuss it with them so they get their full cadre of options."

Gary: I gotcha. I think that's where things are definitely heading. We need to be the guys who are pushing these technologies forward. It's not always easy being on that cutting edge and being on the leading edge, but I feel like we're really getting to the point where this is something that really has legs and is showing that it can stand on its own two feet.

John, thank you so much for giving us your perspective. I really always love talking to you. You've given me lots of good advice on other things in the past. Thanks for taking some leadership in this area, it's really important.

John: You bet. Gary, it's always a privilege and thanks so much for your friendship and including me.

Gary: Absolutely. Take care.

So, friends and colleagues, I think this shows what can happen when we evaluate and re-evaluate our treatment approaches. Lets continue to consider new ways of helping our patients, and then, let’s talk about it.

This has been Ophthalmology off the Grid. Thanks for listening.

Speaker 4: Ophthalmology off the Grid is supported by Ilevro from Alcon.