Lewis Handicaps MIGS Market & Explains Glaucoma’s Emergence

[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 077″]

Glaucoma specialist Dr. Richard Lewis says glaucoma was once the “boring step sister” of the ophthalmology world. But now the chief medical officer of Aerie says the rise in devices and drugs has made glaucoma one of the coolest kids in ophthalmology’s school yard.

10 Top Topics in this OIS Podcast:

1. Glaucoma is ophthalmology’s boring step sister?
2. Why is this innovation in glaucoma happening now?
3. Glaukos approval really showed the value of a “safer, gentler” glaucoma treatment.
4. Lewis on Alcon’s acquisition of Transcend.
5. Is there really a horse race between Glaukos, Aquesys, and Transcend?
6. What are you seeing in improved diagnostics?
7. Glaucoma 360 recap keynote – the good, the bad, the ugly
8. The important role of sales reps in the OR.
9. What’s next for MIGS?
10. Are younger ophthalmologists moving into glaucoma?

Podcast Guest

Transcript

Tom Salemi: Hi, everyone, welcome back to the OIS Podcast. This is Tom Salemi. Thanks for joining us. I had the opportunity recently to speak with Dr. Rick Lewis. Dr. Lewis is of course well known in glaucoma circles, having led both the Glaucoma Society and ASCRS recently. He’s also last year became Chief Medical Officer at Aerie Pharmaceuticals, which is doing so much in glaucoma. So he brings a great deal of clinical and corporate experience to the conversation, to the discussion of glaucoma, which really, let’s be honest, there’s a lot to talk about. And we did. We talked a bit about MIGS and sort of handicapped that race there, or discussed whether or not it is actually a race. We talked a bit about just the innovation in glaucoma, why is it happening now, why is there so much exciting in this sector. And then looking forward, kind of down the glaucoma line, away from developing new technologies and getting into sort of the practice of medicine and the actual surgery, Dr. Lewis and I talked a bit about the important role of sales reps in the OR and about whether or not there’s new blood coming into the glaucoma specialty. So it was really a great, far-ranging conversation. I will let you enjoy it now. Welcome to the OIS Podcast, and enjoy this conversation with Dr. Rick Lewis.

Tom Salemi: Dr. Rick Lewis, welcome to the Podcast.

Rick Lewis: Thank you, Tom. It’s a pleasure to be here.

TS: So I have to ask. I’m sort of an outside to ophthalmology. Is glaucoma always been this cool? Because you guys seem to have the coolest specialty in ophthalmology.

RL: It’s an honor that you say that because for many years, glaucoma was the boring stepsister of ophthalmology, and all the excitement was in anterior segment, cataract treatment or in retinal disease. But over the past few years, probably the last five, there’s been just tremendous innovation occurring. A lot of it was there, but it was sort of below the surface. And now everyone’s getting involved because they see that we’re going to be able to be more specific in our diagnosis and offer treatments that are safer and better. And so it has become very exciting.

TS: Why is all of this happening now? Is it just a matter of time because so little had been done before, because it was so sleepy before? Or has there been some other external force that’s led to these many spotlights being shone on the glaucoma space?

RL: Well, that’s a good question and sort of a complicated answer. But there’s a number of issues there. If you look at it from the therapeutic side, we’ve had good drugs for many years that lower pressure, but we’ve have issues with any chronic disease with compliance adherence, and patients don’t take their drops. And we’ve had issues with side effects. And then on the surgical side, we really haven’t had a lot of – we had not had a lot of innovation until recently with the MIGS space. And the work in the MIGS space, which is micro incisional glaucoma procedures, has been discussed and we’ve been involved in these for at least ten years in this. But it wasn’t until Glaukos got approval in the US and we began to see the value of a safer, gentler glaucoma procedure that I think really turned it around. So Glaukos deserves a lot of credit for doing a lot of the heavy lifting in getting FDA approval, which was tough for the FDA because it was an entirely new area, but also for getting reimbursement, and then taking on the challenges of teaching the ophthalmic world, particularly the anterior segment surgeons, who weren’t glaucoma specialists, that they can do glaucoma surgery too in a safe way. That whole safety aspect is critical.

TS: And I’ve never seen a space heat up like MIGS just has. And you and I both awoke to the news this morning of this Podcast of Alcon’s acquisition of Transcend. There’s a horse race on now, isn’t there? We’ve got three big players in this space.

RL: There is. And it’s interesting. You know, it’s a horse race in some ways, and not in others. The MIGS space has always been defined by the target tissue. So for example, the eye stent has been directed at the canal space. Transcend has been directed at the suprachoroidal space, and AqueSys with the Zen procedure is in the subconjunctival space. So what that implies is that we have these safer procedures, but they’re directed at different types of glaucoma. And maybe the race will heat up when they begin to cross over and show that these different mechanisms can work in different spaces. But right now, they’re really defined by their target tissue.

TS: That’s a great distinction. I guess I’ve seen them as competitors. It’s easy to do that. They’re all – have similar products in the same area. But at this point, there really is very little cross over between the three?

RL: Well, at this point, at least by FDA labeling will indicate that the canal space is limited to open end glaucoma; the Zen perhaps may be restricted to more advanced disease. It’s just thinking by labeling. Now that of course doesn’t mean a lot when it actually gets to the market – the market the doctors will use it for whatever they indicated it for. That’s really exciting. And all three of these companies get on the market, it’ll be fascinating to see what types of diseases it will treat. Will it hopefully will treat both primary and secondary glaucomas in some of the more advanced problems. And that’s what we’re all hoping for in glaucoma, despite the labeling.

TS: How do the availability of these devices – and right now Glaukos is the only one with the product on the market, but the other two are a year or two away, I think – how does the arrival of these products change a glaucoma practice? Does it shift you away from medication, more toward procedure? Does it really upend how you practice your medicine and how you treat glaucoma, or how others would treat glaucoma?

RL: Yeah. It’s again a good question with a complex answer in that it’s opened up glaucoma surgery to the cataract surgeon. Prior to this, they really did not want to get involved with trabeculectomy, a more class approach with using mitomycin and so forth. So in some ways it’s opened up the area to a broader group of surgical specialists. And an effort now, it’s also made combination surgery which is cataract plus glaucoma procedure, whether it’s Glaukos or whatever, it’s made the combination procedure more attractive than it used to be because before, the combination procedure had a lot of complications. So that was good. On the other hand, medications haven’t been ignored. We still have a need for better, safer, more potent medications because glaucoma is a very broad disease, and surgery won’t cure it. It’s not going away because of the MIGS procedures. It’s I think we’re more aware of it, I think we’re more aggressive treating it, and perhaps we’ll get patients off some of the medications. But there’s still a broad spectrum of glaucoma patients that will need medications. So we still need better medications. We still need safer, more effective, we need better drug delivery systems and a whole slew of other options on the medication side, until we come up with a cure, and the cure is a long way off.

TS: And as I indicated in the intro to this, you work with Aerie. You’re Chief Medical Officer, sort of part time basis. What can you share about Aerie and its approach? And just perhaps speak also more broadly about what else might be coming down the pike to treat glaucoma on the medication side?

RL: Well, what we’ve always wanted in medications is drugs that are easy to comply with, that lower pressure without a lot of side effects, and perhaps could do other things to the target tissue, areas worked on a drug that – Rhopressa – that at least in animal work suggest that there may be some beneficial effects to the target tissue. The data is still not confirmed in humans. But it’s taking glaucoma treatment beyond just pressure reduction, and that’s what we’re hoping for. If we can prove that, that we can help the target tissue, which in this case would be the trabecular meshwork, that would be a fabulous thing because we’ve not been able to enhance that. And then further down the road, medications, whatever medication it may be that provides neural protection, neural regeneration would be the ultimate – that would be the ultimate goal of all, that we could actually restore some benefit to the optic nerve. And thus far, no drug has been able to prove that. Now, along the way, the drug delivery space is heating up as well, as you may have heard. Of course Allergan, Envisia, and to some extent Aerie all have drug delivery approaches here that will enhance our patients’ ability to take their medications on a more regular basis. And right now we depend on them to put the drop in, and we know they don’t do it. So a drug delivery piece where they can maybe only have drug applied every four months or every six months would eliminate the compliance part of the glaucoma puzzle, that’d be great.

TS: And you referenced this earlier, the change in diagnostics, the availability of better diagnostics. What are you seeing there and what does that mean for glaucoma patients and physicians?

RL: Well, again, there’s the big problem with glaucoma has been either the under diagnosis of so many patients who have it don’t know they have it, or the patients who have ocular hypertension but don’t really have glaucoma. And so what we’ve been always wanting is more sensitive and more specific treatments to be able to detect it at an earlier stage. So there’s a lot of work being done on IOP monitoring devices that will be more specifics, so instead of checking pressure maybe two or three times a year for a few seconds, we’ll have devices, either in contact lenses or other ways, that would provide 24 hour or longer follow up. So we could really get a sense of what patients’ pressures are during the day, while they’re sleeping, while they’re playing sports, whatever they’re doing. And that could really give us a good handle, kind of like an EKG does, a good handle on someone’s pressure. But then beyond that, the diagnostics in the optic nerve is changing, where you’re getting much more sensitivity out of OCT measurements at the level of the ganglion cell and into the optic nerve, nerve fiber layer area that will help with early detection of glaucoma. So a lot of excitement on all these levels, and all seems to be happening now. So it’s a great time to be in glaucoma.

TS: And speaking of new things, I know a couple of weeks ago you were at Glaucoma 360. You gave a talk there. What was your talk about? And share with us some of your insights, some of the takeaways from the meeting.

RL: Well, I had the honor of giving the Sutro Lecture, which is the main lecture of that meeting. And this was focused on my 30 years of consulting in glaucoma. And I pointed out the good, the bad and the ugly of some of the things that I’ve been involved with, some of which were very helpful for patients, and some of which were complete failures. And I think we have to learn from our mistakes in all aspects of this, both in drug development as well as the launching of the products. And I pointed out a number of problems and some successes in getting clinicians to change behavior and also in helping our patients. So it was a lot of fun for me to be able to put this together. I was only given 30 minutes; I probably could have spoken for two hours because there’s a lot of good, bad and ugly along the way. But all in all, it’s been very, very good, and a big honor for me to give that talk.

TS: Can you share one or two ugly developments for it? You’re right, it’s not something that we often do in this industry, look at the growing pains.

RL: Well, you know, one of the ones was a launch of a product. Well it was originally an Israeli company, Kolapinol that launched the Express. And they contracted with Ciba to launch it in the US. This was about a little over ten years ago. Ciba really didn’t have much experience in the surgical field at the time that they hired some sales reps who then had a certification program for the Express device at the American Academy meeting site. And so in about a 5 to 10-minute session, you were able to take your device, which had an injector, inject a few into a pig eye, and then they gave you a – printed out a certification. So people went home and felt they were experts in glaucoma surgery. And it resulted in a series of complications – choroidal hemorrhages and infections and bleeding – because they really didn’t spend the time to really teach the surgeon how to do it. And it led to the – they pulled the device off the market, and had to relaunch it in a different way. It took a couple years to relaunch it. Ultimately, the Express turned out to be a good device, and Alcon acquired the Express a few years ago. But it was an example of very, very nearsighted approach to launching a clinical product. The reverse of that, I think, was what Glaukos did with the iStent, with how they very carefully selected surgeons who were very, very competent. They actually sent many of them to Armenia to do additional training off site. They had their reps well trained in the OR, had them do a certain number of cases under direct supervision before they were given the green light to go. And I think that’s the two extremes of a surgical launch. And very important lesson that was learned. And then of course there’s other lessons that were learned, products that did excellent in clinical trials, and when they got in the market, production changes caused them severe complications. So again, I could have talked for hours about some of the things that happened here. And I touched on a few of the more noteworthy ones that I think hopefully won’t happen again.

TS: Well, you’ve got an open forum here, always an invitation to come and share more. Just a question about surgery. In other specialties, orthopedics in particular, the sales rep is a critical part of that whole procedure. Is that the case in ophthalmology as well? Is there always a representative from the company as part of the surgery? Or is that a new development?

RL: You know, it’s an important part of it. And the surgical teaching is so critical. But there’s more barriers now to getting companies have reps in. The government and FDA have put a lot of restrictions on having reps in the OR. And that’s a big change and a very negative change because a lot of technology in ophthalmology is – well, let me back up. Ophthalmology is very innovative, and there’s a lot of new things constantly going on. And so it’s very hard to get adequate trainers out. And it sort of violates some of the principles that – in the new FDA guidelines and CMS. So it’s really complicated having reps in the OR. Alcon is struggling with this as one of the bigger surgical distributors. It’s so important, and I think we’re going to pay a price for it in getting adequate training. So I hope we don’t lose it entirely.

TS: I don’t think people appreciate the role that they play in these procedures. I know I didn’t until I started covering this industry. It’s fascinating.

RL: Yeah, yeah.

TS: What were some of the other takeaways of things you saw at Glaucoma 360? That – new technologies perhaps that you’re excited about, or just developments that you were happy to see?

RL: I mentioned the drug delivery space –

TS: Yeah.

RL: – is really heating up, that they’re – and I’m a consultant to a couple of these companies, Allergan and in the past I was with Envisia. They both have drug delivery inserts that go into the eye. The Allergan device is based on their Ozurdex platform, which is already approved for delivery of steroids in the posterior segment, and they’ve modified it to deliver bimatoprost, which is Lumigan, in the anterior segment, in the anterior chamber. I’ve been involved in their trial, and they’re fairly far along with this process. They have – it’s safe, it delivers drug for 4 to 6 months, and it seems to be free of side effects. The question in some of these anterior segment delivery segments is whether clinicians and patients will be willing to go along with the slight risk of an anterior segment ejection, given the eventual freedom of having to put drops in for 4 to 6 months. It’s a little bit of a mind shift for both doctors and patients. It’ll take some time to, I think, show that this is safe enough to allow widespread use. So it won’t be going – neither of these products will be going to the FDA for a couple years, but it’ll take some time for, I think, all of us in ophthalmology to accept that, on the one hand. On the other hand, we know that these harsh, plain injections for treating macular degeneration is so widespread that I think the younger ophthalmologists will be probably more accepting of this new changed technology than the older ophthalmologists. But I think ultimately that’s the direction that therapy is going to be going in the drug delivery. So that’s exciting. And there’s a whole slew of other items along the way of drug delivery, both in contact lenses, gels that are placed inside the cul-de-sac of the eye, there’s rings. There’s a lot of drug delivery work going on that’s very interesting and that would change the compliance-adherence problem we have. So there’s that aspect. And of course we’ve talked about the surgical side of this. MIGS has really transformed the surgical side. And I think what we’re going to ultimately see will be a merger of the drug delivery and the MIGS space, so that perhaps we’ll come up with drugs that can enhance or provide neural protection and perhaps could be delivered using a MIGS device that would both lower intraocular pressure and perhaps, when a drug is discovered that is neural protective, that could be a way of delivering it. Because getting drug to the posterior segment is very hard, and it probably will require some type of drug delivery system to get it back there. So we’re getting closer on the delivery side; now, we just need to find the drug that can provide the neural protection.

TS: You mentioned younger ophthalmologists. Is the cool factor of glaucoma – because of that, are you drawing more people to the space? Has there ever been a shortage of people, of specialists in glaucoma? And has that changed in recent years?

RL: You know, it’s a good point, and it has really has really changed. There wasn’t a – ten, fifteen years ago there wasn’t as much new happening in glaucoma, and the number of residents applying for glaucoma fellowships had really dwindled. And now the reverse is true. A glaucoma fellowship is highly sought after because you have that marriage of surgery and medical treatment that is kind of unique. And so glaucoma fellowships are highly sought after now. It’s one of the more highly sought after fellowships in all of ophthalmology because of all of this new technology happening. It’s a great time to be in it. And you’re seeing then I think it’s bringing a lot of young, new ideas to the space, which is all good.

TS: Terrific. And we’ll finish up with kind of what we started with, the acquisition of Transcend Medical by Alcon. You mentioned prior to this phone call that you were getting a lot of texts from colleagues about this. What’s the general feeling of the deal? Is it a surprise? And what’s your feeling? Were you surprised to see it happen? And if so, why?

RL: Well, I was a little surprised because as we all know, there’s been a bit of a shakeup at Alcon, and no one knew what direction it was going to take. So I think it’s fabulous that they are pursuing products and going to innovate their surgical space. And I’m particularly excited because as a glaucoma specialist, I’m really happy because I think it justifies the MIGS space even more. You know, we’ve had lots of action on the MIGS space, where we had, you know, Glaukos went public over a year ago. We have Allergan purchasing AqueSys and the Zen, and now we’ve got Alcon purchasing Transcend. So I think it justifies the space. I think that will help on the regulatory side because I think we’ll get more support from the big boys in getting regulatory approval on a perhaps faster basis. I think it’ll justify on the reimbursement piece; it’ll make that side of it easier because now you’ve got the bigger company’s support behind it. And most importantly, I think it’ll bring a lot of attention to the broad diversity of surgical options in glaucoma. I think this is great. About ten years ago, Ike Ahmed and I had a course called The Cutting Edge, where we were talking about this new area called MIGS, and no one really understood it. We had all the beginning companies and no one had a lot of clinical data yet. And now fast forward, and we’re seeing them acquired by the big principles. It’s very reassuring and I think it’s great for ophthalmology.

TS: Terrific. Well, enjoy this time. This is your time, glaucoma specialists.

RL: Right. Thanks a lot. Thanks for the interview. This is wonderful.

TS: Excellent. Have a great day. Thank you.

RL: OK, you too. Bye-bye now.

TS: Dr. Lewis, thank you for joining us on the OIS Podcast. I really enjoyed our conversation and I’m glad glaucoma’s time has certainly come. And to all of our listeners, thank you of course for joining us again today, and we very much want to see you at the next OIS. So go to ois.net, register to attend OIS@ASCRS on May 5 and we will see you in New Orleans.