Roundtable Discussion: The unmet need in standalone glaucoma treatment
Mehul Nagarsheth, MD:
All right. Well, thank you so much again for setting this up. This is an exciting time for us in glaucoma. I feel like the last 10 years in particular have been very exciting for us as we start getting into more items, more surgical techniques, more devices that we can use to help treat patients with glaucoma and try to prevent blindness, and earlier stage. Back before 2012, 2013, our only devices really was trabeculectomy and tube shunts. And then since 2012, we’ve had a burst in the MIGS space, this minimally invasive glaucoma surgery. More and more devices started coming down the pipeline. And finally, in 2022, last year in the fall, FDA approved the use of a standalone stent, the Glaukos iStent Infinite, which has really helped to innovate our whole field of surgical glaucoma. So I’m very fortunate today to be able to speak with some of my colleagues also who I understand are doing a fair amount of glaucoma surgeries in their practice. So we have Alex Gerber over here from Rhode Island. Alex, would you mind talking to us and telling us a little bit about yourself and your practice?
Alex Gerber, DO:
Sure. I practice at Koch Eye Associates in Rhode Island. There are a few offices spread throughout the state actually. I did my fellowship in cataract and LASIK mostly about going on 14 years now. And actually, sadly, due to the shortage of glaucoma surgeons, I had to get into the MIGS space along with cataract surgery just because we were in need and we really couldn’t get anybody. So I’ve been kind of learning and I’m doing all that myself as well.
Mehul Nagarsheth, MD:
Perfect. Yeah, that’s great. And then we also have Valerie Trubnik over here from New York. Valerie, would you mind telling us about yourself and what sort of practice do you have?
Valerie Trubnik, MD:
Sure. So I work for OCLI, so I work as a glaucoma specialist. I do some comprehensive, but mostly glaucoma. And we’re across the state, but multi-state now. We are a PE-backed ophthalmology practice, so we’ve kind of sprawled across multiple states now. And I do a lot of MIGS. I do obviously bread and butter glaucoma surgery as well, but it’s nice to have MIGS as an option of course.
Mehul Nagarsheth, MD:
Yeah, absolutely. I feel like we’re all huge fans of MIGS and it’s nice just having multiple different options. I feel like the glaucoma paradigm for surgery, traditionally it’s always been just two things that we really had, trabeculectomy and tube shunts, and of course the results are so all over the place with these traditional surgeries, I feel like I can do 10 different trabs on 10 different patients and have varying results for everybody in the early or the late post-operative stages. So it’s nice to have different things that are more standardized for patients.
So today we’re going to talk a little bit about standalone MIGS and glaucoma procedures. One of the things that has popped up is Nathan Radcliffe, of course, somebody that we all are familiar with. He recently published an article in Current Opinion of Ophthalmology, which supported the use of standalone procedures. In that, Radcliffe reviewed the limitations of today’s glaucoma treatment paradigm and outlined the case for how standalone MIGS is a better option for the future of glaucoma management.
So thinking about what our current paradigm is for treating glaucoma the traditional way is you would start them, if you see a patient is progressing, usually we start with topical medications. This is then if they’re getting worse and we start thinking about laser trabeculoplasty. And then last resort is always surgery. Now I guess things may be changing the tide. So Valerie, we’ll start with you. What do you think about how the traditional clinical protocol is? How do you feel like that’s worked in your practice with starting with drops then laser and then surgery?
Valerie Trubnik, MD:
I think there’s always a role for that. I think patients find it incredibly comforting, as I’m sure you guys all know. So when they hear that they’re going to use drops for glaucoma, they just feel so much better. They feel like there’s such a huge weight lifted off their shoulders. So there’s always going to be a role for that in any stage of glaucoma.
But I think we’re now realizing that the drops are not as great as we think they are. So obviously there’s a lot of non-compliance, there’s tons of studies showing that, and I’m sure we all see it in our own practices, especially after COVID. I see so many patients coming back years after just not following up, not taking their drops, terrible glaucoma progressions. We know that drops can cause all kinds of side effects, the list goes on and on, [inaudible 00:05:46], dry eye, Meibomian gland dysfunction and ocular toxicity. So we really want to look for something better, something that would control the pressure, would have minimal side effects that we’re not afraid to take them to surgery and really reduce glaucoma progression and catch these patients early, which is what this whole kind of wave of interventional glaucoma is all about.
Mehul Nagarsheth, MD:
Absolutely, totally agree. The compliance issues, the side effects and then patients that are… they may not respond to certain eye drops, so you get into this cycle where you try different medicines just to see what works for the patient. And I totally agree, it’s always nice having medicines as an option for us. Alex, what do you feel about this current paradigm? Do you feel like we’re at a stage where things need to be shifted or that we can kind of modify our paradigm a little bit?
Alex Gerber, DO:
Yeah, I think we’re kind of past that stage. I think we should have shifted a while ago just because I think people are realizing that eye drops, especially generic eye drops, they just don’t work. In fact, I think I’d like to propose the fact a lot of those people that we think are non-compliant just because the eye drops just don’t get where they need to be. And I think we’re seeing that shift in the paradigm with MIGS coming along that we’ve been using earlier, and also with medicines such as Durysta that can be implanted now and working from the inside, which as I’m sure you guys know, works so much better. I think drops definitely have a role, absolutely. For those that can’t tolerate a surgery or any kind of procedure or a bit scared of a procedure, drops will have to do, they just don’t work that great.
Mehul Nagarsheth, MD:
Yeah, prior to… I guess thinking back of my practice, I’ve been now in practice for over 10 years and back in 2010 to 2012, all we really had just thinking about it were drops and then invasive surgeries. So I feel like when I was just starting off in practice, I would always be across the gland in first line. If that didn’t work, then you… Or if you get minimal results, you add another medicine or you do an SLT.
I feel like my way of trying to approach these patients has really changed now because I feel like it’s rare… not rare, but I feel like it’s just much less common now compared to before where I don’t have patients on that many medications. And I have to thank that to us being able to do MIGS, us being able to do laser treatments and try to avoid some of the burdens of some of these topical medicines and still stabilize their disease over time, which really speaks volumes, I feel. Patients that are in general on less than… I’m thinking a combination drop and prostaglandin after. If they’re on more than that, then I feel like I’m leading towards surgery of some sort.
So Valerie, when you think about the standalone MIGS trying to meet another population of patients, what population do you think that that would work for? If you’re doing a standalone MIGS, a standalone stent of some sort, which patients do you feel like are going to benefit the most from that?
Valerie Trubnik, MD:
I think there are actually a lot of groups of patients that would benefit from standalone MIGS, especially the standalone iStent for instance. But we’ve been kind of limited, at least where I am in terms of reimbursements and insurance coverages as to what we can use. But standalone MIGS, we can use it in pseudophakias and we can use it in patients who, I have tons of young patients who don’t really have cataracts yet and I don’t need to do cataract surgery on them. I could just do a standalone MIGS.
And then obviously based on the new study, not something that I would’ve originally thought of using these standalone MIGS on, but using it on patients with refractory glaucoma, which I know I’m jumping a little bit ahead, which I think is really refreshing to see that because I’ve always thought of MIGS as something that could only be applied to mild and moderate glaucoma, maybe one to three meds, would never have thought to use it on someone on four to six meds. I just kind of would’ve thought, let’s do another tube, let’s do a cycloblative procedure, or whatever it is. So I think there’s so many groups that we could use it on. I just think we need better coverage.
Mehul Nagarsheth, MD:
Yeah, you guys both bring up excellent patient demographics. I feel like standalone MIGS, it can help with any age range, whether you’re phakia or pseudophakia, just like how Valerie was mentioning, folks that have trouble with multiple different medications if they’re on different sorts of eye drops and over time they just don’t tolerate, their ocular surface gives out, those are excellent candidates.
And going back, Valerie was hinting at the article that came out with iComet, how it was used to treat refractory glaucoma, not only refractory glaucoma, but also patients that were on maximal tolerated medical therapy. And in that study they had 72 eyes of 72 patients, 61 of those had failed prior filters or tubes or endoscopic cyclophotocoagulation. And 11 of those patients were max tolerated medical therapy without prior incisional surgery. And they found that 76% of those folks ended up achieving a 20% or greater IOP lowering compared to the baseline or lowered their medication burn. That’s a huge percentage in that population to benefit from a minimally invasive glaucoma surgery where essentially you’re not adding any extra major risk to their eye by doing these procedures.
And so it really is quite remarkable that they’ve achieved those sort of results in that sort of population. It’s not something that many people would’ve expected. This group of the max tolerated medical therapy, they’re the ones that had the greatest drop for intraocular pressure compared to those that failed prior surgery. So it always makes me think that earlier intervention, just like how Nate Radcliffe was suggesting, it is probably the way that we have to go. It’s like you optimize their pathway, their trabecular pathway, the conventional outflow pathway in some way, try to restore it as much as you can and really get those eyes functioning again. So it’s nice to know that we have more and more options that keep coming down the pipeline.
Valerie, do you you want to share any sort of results that you’ve had, I guess with standalone MIGS, whether it be Durysta, whether be iStent Infinite or goniotomies of some sort. What are some of the results that you’ve had in your patient population?
Valerie Trubnik, MD:
I’ve been doing something interesting, I started to introduce the iCare HOME tonometer. Have you guys have been giving scripts to patients about to use the tonometer at home?
Alex Gerber, DO:
I haven’t yet, no.
Mehul Nagarsheth, MD:
I have it. I don’t think that we really have it. I don’t think patients are going to, or at least my patient population, they probably won’t pay for anything like that.
Valerie Trubnik, MD:
They rent it. So I pick very specific patients, younger, more tech-savvy who are willing, and I would give them a script. I don’t think it’s particularly expensive, maybe it’s a little bit over $200 for a week. And I think that’s kind of all that you need. And so I’ve done this on patients before, let’s say SLT or Durysta just on drops before surgery and then I’ve given it to them after surgery and I’ve seen a significant difference in fluctuation of intraocular pressure. So I think this is kind of really how we need to treat our glaucoma patients because we get this false sense of security. They come in, we check their pressure, your pressure is 14, we pat them on the back and we say goodbye, but we really don’t know what goes on. And this is how we’re really going to show that MIGS and all these interventions are better than drops because they’re just not working well enough by demonstrating it with hard data. So here’s the intraocular pressure curve before and after MIGS, and why is it so much better?
So I’ve seen improvement on that and I’ve had my success stories. Glaucoma success stories are very limited. So if you take refractory glaucoma and you do iStent Infinite, that’s kind of all I was allowed to do by my practice. Just kind of follow the rules and what you’re allowed to do. So I’ve taken patients post-trab tube, a psycho ablative procedure, on Diamox, maximum medical therapy, and I said, oh, I don’t want to do another tube on these patients, so let’s try iStent Infinite. And this is kind of our win. They got them off of Diamox and lowered their intraocular pressure to an acceptable number. So let’s say if their target is in the mid to low teens, I’ve gotten them from 23 to a 14.
So for me, that’s a huge win despite the fact that they might be on still five or six drops. And the patients are very happy because they don’t get to have another tube in their eye. So I think that’s great, and I’m so grateful for that study that’s out there. And of course, cataract and iStent Infinite together, great results. I think it’s great that we have all this out there. And it doesn’t work on everyone, but the majority do pretty well.
Alex Gerber, DO:
I got to say, the idea of sending somebody home with a tonometer, brilliant. That is so cool. You’ve seen the results. And also, yeah, you’re absolutely right, how many times do we have somebody coming in? The pressures are fine. They’re ranging in mid to high teens and it seems like they’re doing okay, but we see changes in their visual field test and there are in the film, what’s going on. Until we finally catch that one time where their pressures actually spike where it’s above 20 or close to 25 or so, and then oh, that explains it. Your pressure’s just been spiking, but we haven’t caught it. Even though you’re on an eye drop and you should be nice and stable, but you’re not because it’s an eye drop. But we have this procedure that can leave you stable throughout the day, really, as you you’ve seen with sending people home with a tonometer.
Mehul Nagarsheth, MD:
Yeah, you hit the nail on the head, I feel like. These patients get so set on the pressures over anything else, so one high pressure readings, meanwhile their field is deteriorating, I feel like you’re doing a disservice not trying to do anything further if they’re kind of stuck on that one pressure reading. So yes, it’s just dealing with people. That’s just the challenges that we’re always going to have in glaucoma, I always have to equate it just like blood pressure. I feel like until they actually see. If their blood pressure is high and they’re not having any symptoms, that’s pretty common. But when they actually have their own blood pressure cuff in their house and they’re checking it, then it’ll kind of sink into them that, hey, something’s not right. Some of that is patient driven, they have to kind of accept it over time in their own way. So when we’re thinking about MIGS and everything, I feel like there’s a lot that’s being done. It just continues to expand and get more innovative.
The thing that I love about this iStent Infinite is the safety profile. I feel like these stents now, the iStent has been around since 2012, FDA approved, and we’ve seen essentially minimal risk as far as endothelium toxicity to the cornea. So you know that these stents are very safe in any sort of patient population. Anyone can have glaucoma itself, and as they start aging, of course their health can deteriorate, they can be faced with more problems. So these are folks that you don’t necessarily want to do trabs or tubes if you’re worried about their other health issues. The iStent Infinite is great because it’s quick. They’re not under too much anesthesia, so you don’t have to worry about the rest of their health. And the visual recovery is relatively fast because you’re not inducing that much inflammation inside the eye.
And so I feel like these are some things that we need and ideally it’s like we’re getting to the point where we can try to be more standardized with our results as a collective group in treating glaucoma. It’s amazing, from my standpoint, I feel like ever since we’ve been doing cataract and iStents and cataract and Hydrus, the amount of times that I’ve needed to do a trabeculectomy or a tube shunt have really declined, I feel like, since when I first started where those were our only options. So I feel like intervening earlier in this mild moderate stage, while these were FDA indicated to do cataract with stents, it’s really helped diminish some of the need for these folks to have more invasive surgery. And the studies have all shown that, fortunately, with these stents.
Alex, we’ll start with you. Where do you feel is going to be our next direction? Do you feel like it’s going to be an increased boom in standalone MIGS? Are we leaning towards that as far as more devices are going to come down the pipeline, more sort of procedures will come down our pipe pipeline for standalone procedures?
Alex Gerber, DO:
I certainly hope so. I certainly hope so. I’m sure you’ll agree, I think glaucoma is a surgical disease. We’re only going to be able to do so much with medical topical therapy. In fact, we kind of started down this trend back maybe about 15 years ago. I was in residency at SLT, was really coming on and really getting into the swing of things. In fact, there was some studies that would promote us first-line therapy for certain populations. And then it sort of trailed off, we went back to eye drops, eye drops, eye drops. But now with MIGS, yes, yes, hopefully, especially with standalone, and if they have pretty much almost no burden, surgical burden, recovery burden or eye drop burden for a patient like the iStent Infinite does, I certainly hope that’s the direction we’ll go into is that everybody will go back to thinking that glaucoma is a surgical disease and the earlier we do something procedural wise, the better for the patient.
Mehul Nagarsheth, MD:
Yeah. Valerie, do you have any thoughts on that? I feel like Alex, he was very eloquent with how he approached that question itself. It was excellent.
Valerie Trubnik, MD:
I mean, I totally agree. I definitely think most of us are moving away from… I mean, there’s always going to be room for trabs and tubes, but we do need to move into intervening earlier. I think that’s really key and really important. And yes, I think glaucoma is a surgical disease, but we’re always playing catch-up, constantly. So constantly I’m talking to patients and they’re showing me their visual fields and how they’re missing chunks of their visual field and it affects their quality of life. So I can’t reverse that now, but I want to stop that from happening.
And so I think that’s kind of what we really want to focus on, doing these things earlier on in the disease, mild glaucoma, forget the drops, let’s start with some of this first-line therapy, Durysta, primary SLT, standalone MIGS because they do have such a wonderful safety profile, we’re not afraid to take them to the OR. I mean, I never take these things lightly. Anything can happen. You operate long enough, you realize that anything can happen in the OR. But most of them do exceptionally well. And to your point, even those patients with significant comorbidities, those on anticoagulation, this is still such a great procedure. They recover so well. So we need to intervene earlier so they don’t progress. So maybe we can never eradicate it, but we can certainly reduce the burden.
Mehul Nagarsheth, MD:
I think I’ll leave it with some final thoughts. One thing that I was always thinking, I feel like every other specialty, like neurology and cardiology, they have, in a way, their own sort of set algorithm and criteria, even a potential calculate to determine who gets what treatment. If they have a stroke or if they have a heart attack, what sort of treatment would you give? And I guess my thought is that glaucoma, everyone is so varied. Now, there’s so many different options that we have. And if there’s a way that we can risk stratify patients based on their demographic, based on the nature of how much field loss they have, what their pressure is like on a diurnal curve, how many different medicines they’re on, how aggressive versus how mild the diseases may be, you plug it all up into some sort of super-duper calculator and it comes out with this is what would work the best.
Almost like for IOL measurements when we’re using these different formulas, it’s based on this database, we have a database of how to run glaucoma. It’ll end up being more standardized and hopefully better long-term outcomes for these folks if they’re expected to live another 20, 30 years. What will have the best sort of outcome for you? And I feel like in general, at least this is just anecdotal sort of evidence for me, I always feel like the ones that I’ve done the stents on are going to out-surpass even some of the folks that I’ve done bigger surgeries. Thinking about my trabs and tubes I’ve done on high myopes itself and seeing them now as they’re aging, developing hypotony or struggling with a blood leak or something like that. I feel like these standalone stents in particular are really safe and effective. So I guess that’s my thought is that maybe eventually we can get to the point where everything gets standardized. We have a set database, a set sort of risk profile for patients. And what would be the best interventions, surgical or medical, for these folks for the long term?
Valerie Trubnik, MD:
I think that’s a great idea. I like it.
Mehul Nagarsheth, MD:
Yeah, it’s great.
Alex Gerber, DO:
You touched upon a great point where I think we’re talking about the lasting effect as well, I don’t think anybody’s really gone into that in depth there. How long do you expect the trab or a tube to last? We all know it’s going to have some time they’re going to fail. It’s inevitable. And we’re putting in the implant, or three of them in the case of iStent Infinite, and I would definitely expect that to last a lot longer than something that can just close up or scar down, to be honest with you. So I think we’re probably looking at a longer lasting effect as well.
Valerie Trubnik, MD:
I think the other nice thing about the stents or whatever it is, whether it’s the iStent or the Hydrus, it still leaves the conj to, we could still manipulate the conj. It’s still leaves a good proportion of the angle open, so we could put the eye dose in there, we could put something else in there. So there’s a lot of opportunities, whereas if you stick a shunt in there, you just have three quadrants left over. So there’s not a lot of room to work. So I think it leaves a lot of opportunity open.
Mehul Nagarsheth, MD:
Yeah. Thank you guys. Thank you so much. I feel like this was an excellent discussion. I want to thank Valerie, I want to thank Alex for coming and joining this discussion. Glaucoma is a frustrating disease. It makes you humble, it makes you cry, it makes you happy with a little bit of a pressure reduction that patients aren’t noticing, but this is our challenge that we have being in this field. And it’s nice to see the innovation and the effectiveness of some of these procedures to help our patients in the long run. So I hope for just continued improvement and I think everyone wants better insurance coverage for this. So thank you guys so much. Thank you for attending.
Valerie Trubnik, MD:
Thank you for being a great moderator. We appreciate it.
Mehul Nagarsheth, MD:
Oh, God. Please.
Alex Gerber, DO:
Thank you. This was great. Thank you. Thank you.
