[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 102″]
Copenhagen was the epicenter of the ophthalmology last week as several clinical meetings including ESCRS, EuRetina, and EuCornea convened in the city. OIS Podcast reports from the hallways, meeting spaces, and exhibition floor.
Tom Salemi: Hey, everybody, this is Tom Salemi. Welcome back to the OIS Podcast. We took a little bit of a field trip last week. We went to Copenhagen and had a terrific time. Copenhagen seemed to be the center of the ophthalmology universe last week. Had a convergence of several clinical meetings, including ESCRS and EuRetina and EuCornea. And OIS of course had to be there. So I was armed with my handy dandy microphone. I stormed the Bella Center in Copenhagen, and found some interesting stories to share with you. This is a very exhaustive project. Kudos to our producer, Mario Schemia for weaving all of this together. I hope you find this visit to the floor, the exhibition floor at ESCRS, EuRetina and EuCornea enjoyable. And we certainly enjoyed our time in Copenhagen. Very grateful to see a lot of our OIS friends there. And again, hope you enjoy this project of passion that we put together for the Podcast. And also I just want to remind you we have our very own conference coming up, OIS@AAO. It is happening less than a month away, wow. It’s October 13th, it’s in Chicago. If you haven’t registered yet, please do. Go to OIS.net. We had a blowout affair last year in Vegas; we’re going to do it again in Chicago. So we hope you’ll be part of that. Again, go to OIS.net to register for OIS@AAO in Chicago. And now sit back and enjoy this visit to the exhibition floor at the Bella Center in Copenhagen last week.
TS: Now I’m walking up to the booth at C215. It’s the AcuFocus booth, and I’m going to have a conversation with Al Waterhouse, see if I can sit down with him, talk about the new $66 million financing led by KKR. And AcuFocus also released a new lens, announced it this week. The IC-8 will be released in Europe, so we’ll get the update on that as well.
TS: I’m here with Al Waterhouse, President and COO of AcuFocus. Al, thanks for joining us.
Al Waterhouse: Thanks. You’re welcome, Tom.
TS: So you’ve made a lot of news lately. You rolled out IC-8, and we’ll hit upon that in a moment. But first this new financing is extraordinary. $66 million, led by KKR. Have you done your due diligence on KKR? You sure they have the funding you – the money behind them to really support AcuFocus?
AW: Yeah, we are thrilled to have KKR, and for several reasons. One, this is good news for ophthalmology as an industry to have the sophistication of KKR in our space again, because they’ve been out of the space for a while. I think it’s exciting for everyone. We’re particularly thrilled that, as they’ve been looking to enter ophthalmology for some period of time, that they chose us because I think it’s a real vote of confidence with the small aperture technology. They’re excited about IC-8, they’re excited about the inlay business, and in general small aperture because we think it could be disruptive in our space. And that amount of money with the means of this company allows us to accelerate our growth that’s happening in the US. It allows us to continue to do R&D work because we have other applications we think we would – that pertain to this technology, and of course launch IC-8 here in Europe. And that’s what we’re spending a lot of our time with here at the show is we’re just now in a position where we’re actually producing our first production lots as we’re standing here. So coming out of this show, we’re going to make a meaningful launch in Europe.
TS: Great. And we’ll get into IC-8 in a moment, but were you looking for this level of financing before? And what does having this much money behind you – it much make your job so much easier not having to worry about that for a while.
AW: Yeah Yeah. Well, it makes it easier. We were looking for that amount of money, and the reason is anyone that’s been familiar with it, if your time horizons are short in raising money, you have your senior leadership spending a disproportionate amount of its time raising money. And this was all about raising enough money to build a focus on truly working on the products, serving our customers, meaning both surgeons and our patients, and spending our time doing what we do best, and that’s frankly not raising money. It’s developing these products and producing these products.
TS: I’d also say you’re pretty good at raising money. So how does IC-8 fit into Kamra? Into the whole strategy?
AW: Yeah Yeah. Obviously they’re two totally different products serving a different population. The only thing that’s in common is its method of action. I think the beauty of our technology is that it’s passive and it’s simple. You have a pinhole technology. The only way that it doesn’t work is if you haven’t done the procedure right, because for it not to work any other way, you’d have to violate the laws of physics. So that’s what we really like about the technology. IC-8 will be intraocular lens, obviously, so it’s fitting in the cataract space. When you look at what’s unique about it, what makes it a very unique lens – and I’ve been part of teams that have brought out the products, you know, Nick Tarantino and I worked at AMO for years together. We helped bring out the Technis products and now the Symphony product that’s out now. What makes this product unique is how many different categories it crosses. It can handle a toric patient up to 1 and a half cylinder. It’s going to fit in the EDOF category. It’s going to aid surgeons who have been uncomfortable being in the multifocal space because they felt like well, maybe we couldn’t handle or are comfortable to hit the refractive target, and we don’t like all the bad symptoms that come from that. It’s a very easy to use lens. It’s a very forgiving lens. For the patients that are about to hit our marketplace that are post Lasik, this is going to be the perfect lens again because it’s very forgiving for miss and refractive error. And it’s hard to calculate refractive error for a post Lasik patient. So we’re really excited about IC-8. I think it’s a real winner in the marketplace. We’re going to let the data speak for itself. You’re going to see some of the papers presented here. They’ve already been presented. We’re going to be working on doing more studies. That’s the other thing that this money allows us to do is do more studies to really understand the benefits of this technology as it relates to the cataract marketplace.
TS: So you’ve got a really solid pipeline, you’ve got capital behind you. What are the challenges of taking over a company like AcuFocus?
AW: Yeah Well, the challenge is with a small company. And we’re blessed with a really senior team. That’s one challenge I don’t have, and credit goes to Jim Mazzo, my predecessor. He brought in a lot of experienced folks. But any time you’re a small company, you typically have a single product. We’re lucky; we have two products, but we have a single product in the cataract marketplace. The other challenge is what’s different about our product is it’s a single lens solution. Now the beauty about that is when we’re fixing presbyopia, we’re doing it with a single lens solution. We don’t compromise distance vision. So it’s not monovision. The good news is it’s not monovision, but it’s a single lens solution. Surgeons aren’t typically used to putting in different lenses. So there’s going to be an education component to this challenge in the marketplace. But I think it’s one that I think folks are getting more and more comfortable with because they’re learning about it when they come to conferences like this. So one of the challenges is customer – and the other challenge with a small company is consumer awareness on the inlay side. Right. We don’t have the dollars, and we won’t have the dollars even with KKR to do direct to consumer advertising. Only the large strategic players can do that. But aside from that, I mean there’s so many positives about being part of a small company. We’re very nimble, we can move very quickly, we make decisions quickly, it’s a great culture. You know some of the players. You know, Nick’s been in the industry forever. And so you have those plusses and minuses. But for those of us that have worked in both environments, there’s an awful lot of positives about being part of a small company.
TS: Does the direct to consumer advertising by the larger players, does that kind of create a draft for smaller companies to kind of push into and get pulled along by?
AW: Yeah I think it can. It can. And there’s opportunities to do some direct to consumer work, I think, on the inlay side. We’re actually trialing some direct to consumer stuff in some major markets in a pretty small scale just to see what kind of uptick we have. But I know in the past when the AMO’s of the world have done some direct to consumer work on the refractive side, on the Lasik side, it’s been beneficial I think to the overall market.
TS: And just final question: what does AcuFocus become? Where do you go from here with this? You’ve got this capital behind you. You’ll probably need more at some point, but do you continue to turn out more lenses like these? Do you go into other directions? What’s the long term plan?
AW: Yeah Well, I think the immediate concern for us is making sure that we have a high quality growth on the inlay side, and that unto itself will be a lot of work. Inlays – because inlays have been around for 30 years, there’s some headwind there. There’s a perception that there’s issues with inlays. And some of that goes back to the work we had to do and all the trial and error was done here in Europe. And that’s why you see us doing so much better in the United States. The issues with inlays, because – and Nick will tell you they go back 30 years, the very first attempts – you know, we didn’t have the manufacturing capability we have today. Our inlay, when you think about this, that inlay is 6 microns thick. That’s about 70% of a red blood cell. And then we shape it, we anneal it in the same shape as the cornea. And then we place it in the eye. It’s like having nothing in the eye, almost, when you think about this width. That manufacturing capability – and given all that, as small as it is, has 8400 microperforations in it. So we didn’t have the laser capability to produce those microperforations. We certainly didn’t have the technology to make anything that thin, that reliable. And today we do. So that’s what’s made the big difference and then all of the lessons learned around the procedure, the depth it needed to be at, all the pre-operation preparation for the eye, all the things that go into having a successful surgery now were learned here. And so we want to make sure we take care of introducing it in the United States the way we should have elsewhere. And so that’s going to take time. It takes effort. When you’re creating a marketplace, it’s much different than me introducing an IOL into an existing marketplace. And that takes a lot of effort. So that’s going to take up a lot of what we do is on the inlay side. On the IOL side, it’s going to be doing additional studies to make sure we’re covering all the markets that we really need to. We will probably look at expanding our diopters because right now we’re at 15 and a half to 27 and a half. We need to get closer to the fringes there, go down to 12 and up to 30. So we’ll spend some time there. We have a larger incision size than a lot of IOLs. Now, we’re perfectly comfortable with that because again, we can handle astigmatism. So anything we might induce, and it doesn’t look like we do, but if we were to induce some, we can handle it. But we know the marketplace likes to be sub 3. So we’re going to probably spend some dollars doing that. And so we’re going to stick pretty close to our knitting early because there’s just a huge opportunity in just those 2 areas.
TS: I know I said final question, but one more. You mentioned earlier on with KKR coming in, you get a sense that there’s more dollars out there that are looking to come into the sector. Do you anticipate that? You’re closer to this than I, and talking to other CEOs and other investors, do you anticipate seeing big private equity type players coming into ophthalmology like this?
AW: Yeah You know, I would think you would because it’s a very favorable demographic. It’s a very favorable industry. I think there’s things that, from my viewpoint, having been in other industries, what I really like about ophthalmology is the tightness that exists between the user groups and industry. And credit to some of the folks like Jim Mazzo that have been in this industry forever, they’ve really developed tight relationships that help us bring products to market. And I think again, favorable demographics, particularly in the cataract space as the population ages, and the unmet needs. There’s still a lot of unmet needs. And you’re seeing that. That’s why MIGS has been so popular, right? For years we had the same products in glaucoma, and again, because of technological changes, micro – the ability to go with micro devices has really aided in less invasive procedures. And we still have unmet needs in this industry. So I think any time there’s unmet needs, a big market like this, and the ability to collaborate between industry and the physicians, I think you’re going to see investment.
TS: Thanks for taking some time today.
AW: Yeah Thank you.
TS: We’re going to take a quick break from this series of conversations to remind you to go to OIS.net. We’ve got our OIS@AAO coming. Would very much love to see you there to keep this ophthalmology conversation going. And of course we could not do it without our elite sponsors. That includes Abbott Medical Optics, Aerie Pharmaceuticals, Alcon, Bayer, and Santen. So thank you for those sponsors for stepping up and helping us make OIS@AAO happen. Now back to this series of conversations from the floor of ESCRS and EuRetina in Copenhagen.
TS: I’m standing outside Avedro’s booth. I see new CEO Reza Zadno is holding a meeting with his team. Going to see if he can take a few minutes with us to talk about his plans at Avedro, why he joined, what is up with the cross-linking technology, which of course got FDA approval early this year. But the company hasn’t shipped the medicine out, the riboflavin out that’s associated with the system. But we’ll get an update on that, and what he sees as potential for Avedro. He’s obviously had a lot of great success in ophthalmology, and must see a great opportunity here at Avedro. Let’s see if he has a few minutes to talk.
TS: So is it true you took this job just to get the free airfare to ESCRS?
Reza Zadno: No.
TS: I didn’t think so. Congratulations on the new post. What’s your first stop? And you had a great meeting there, I see. People seem really animated and engaged. So where are you leading folks?
RZ: So I was at InterWest Partners. We led the last round of financing, and during that time I got familiar with the technology. I have called a lot of physicians. We saw great potential in the technology the company had developed, and being first approved product in the US. So those were all the areas that got excited. And then PiXL, using the – because it’s a platform technology that will allow improvement in vision, correcting refractive error, whether it’s for low myopia or presbyopia. So it was very encouraging to see at lunchtime it was a standing room session, a lot of interest. So our focus initially is definitely delivery KXL. We are going to ship our first product in the next couple of weeks in the US. So that is our focus, definitely in the US and outside the US. We maintain focus on that. But also, continuing generating clinical data on the PiXL and bringing this to correcting myopia. I think that’s what everybody’s excited for a new technique that is noninvasive.
TS: I’m very excited about that, as someone with onset of presbyopia. So what is – going to the shipment you’re going to have in a couple weeks, what were the challenges in getting that out? And was there anything that had to be overcome?
RZ: No challenges. So when I – so the company is transitioning from a, I would call it, development phase to a more commercial stage. And that’s where we have made some changes and we’re bringing somebody like Raj. I mean he was one of the early adopters of the technology, he was – so we are bringing – I mean in a small company like us, we have one MD, we have 3 optometrists. So we are bringing all of those in the company. But from a manufacturing point of view, no, there wasn’t any issues. We just have to make sure that all the quality systems were in place, all the – so no issues. We’re just going to ship working with our vendors. There wasn’t any issue. It will be shipped.
TS: And I understand as a startup, you probably don’t want to make that big batch of drugs until you have that FDA approval.
RZ: No, no, absolutely. So all of that was in place. You know, the company had done a good job of putting all the systems in place. But what we are doing is we are allowing the company to grow in the sense of because KXL is in place, but to develop PXL we are putting project teams and plans, three more clinical studies, putting more science. So all of that’s what we are doing. Putting more clinical studies so that we truly understand how the product can be used for all these areas we talked about, the low myopia, presbyopia. So we are putting all those clinical plans in place.
TS: And what is the timeframe for PXL going through regulatory review? Do you have any sense of that yet?
RZ: So those are the timelines we are putting together. I don’t want to give any – I mean definitely it’s approved outside the US, but in the US we are working on that.
TS: And just final question, are you with Visiogen, you’re Chairman of Transcend, Oraya Is this company anything like any of those? I guess Oraya would probably be the closest comp to the type of company that you’re now leading?
RZ: Yes. So definitely I think this company has a huge potential if we execute well. I think this is about execution. We are – I think it has the right market, right product, being first in the US. I think this will be bigger than Visiogen, bigger than Transcend. It’s – I mean just imagine low myopic patients, no cutting the eye. The market for this is just – it’s a huge, huge market. I mean some physicians, more than 30, 40% of the patients are low myopes. So it’s a very large market. But we have to execute correctly.
TS: And just finally, how does it feel to be part of a team again in a company you’ve been investing for so long?
RZ: So you know I was in operations for many, many years. The last 4 years I spent time with the venture side. That was a very good experience for me because I could see the companies through the investor side. As you know, the company really is a combination of investors, employees, and the customer. I was an employee always, but being on the investment side, I see how investors look at it. Having somebody Raj who is a customer in the company really, now we have all three elements. Helps us grow the company. But what I was happy to come back is being back again with the physicians, being right to understand. Because physicians who know, who interact with the patient, they know what the problems are. That is what I was looking for, to be back interacting with physicians and working with a team to deliver a product and improve vision and quality life of patients. So being back and interacting with physician is something I was very excited to come back.
TS: Well, I really appreciate you taking a few minutes. I know you’re a busy man now.
RZ: Thank you.
TS: Thanks again, Reza Zadno, for being such a good sport with my dumb first question. You handled it like a pro, which means just ignore the dumb first question and wait for the serious ones. Now I’m walking up to Alcon’s booth. I can’t see what number it is unless I walk way over here. And I don’t know why you care what number it is, but hell, it’s number C307. And I’m looking at Alcon’s LX3 microscope device. And they’ve got a yellow pepper under there. And if you take a gander inside, you get a really good look at what a yellow pepper looks like up close. Pretty cool. Also begs the question is a pepper technically a fruit? But we’ll save that for another podcast. Hoping to speak with someone from Alcon about their news this week. So let’s see if we can get someone’s attention. All right, I’m here with Josh Anderson, Global Product Director, now releasing – in charge of, I guess, the commercial release of Ngenuity?
Josh Anderson: That’s correct.
TS: So can you tell us a bit about what markets you’ll be in? Tell us a bit first about Ngenuity, and then we can get into what markets you’ll be going into.
JA: Sure, yeah. Ngenuity is a very exciting, transformative technology. It’s our new 3D visualization system. So what it’s going to do is it’s going to replace the oculars on the traditional microscope, and instead put an HDR Ngenuity camera on the face of the platform, and allow customers really to see better, enhance their visualization. Really it’s aimed at improving patient outcomes.
TS: So we’re in the wet lab here at your booth in Alcon, and we can see the old microscopes, or the current microscopes, the way they’re done, compared to Ngenuity. To a lay person, the advantages look apparent. But go over in detail some of the advantages of Ngenuity.
JA: Some of the feedback we’ve heard from the doctors over the last couple years of us taking this around is that they can perform retinal surgery in lower levels of light. So that’s going to be advantageous for them, as well as being able to provide some color channel. So based on certain pathologies that they may be dealing with, their opportunity to enhance some of that visualization specifically can be advantageous so they can actually see more, see better than they can right now.
TS: And the device includes – I see a piece of technology from TrueVision. We had them at one of our conferences. You’ve got an arrangement with them. What are the details of that deal?
JA: Yeah. It’s a business partnership that we went with TrueVision on earlier this year in February. So we’ll have an exclusive arrangement over the next 3 years. We’re really excited about collaborating with them for purposes of Ngenuity.
TS: And finally, you’re here on the floor of ESCRS and EuRetina. You’re releasing in Europe and the US. Tell us a bit about your commercial release plans, and what kind of feedback are you getting from folks here?
JA: Well, feedback has been really exciting thus far. Again, we’ve had the opportunity to take this system around for the last year, year and a half, and learned a lot along the way, and continue to improve upon it. So we actually have a newer display that we’re launching again in Europe as well as the United States. Our software has been improved over previous versions as well, and our processing speed is faster than it has been in the past. So the feedback this far has been outstanding. A lot of excitement out there in the marketplace. So we just got FDA approval just a couple weeks ago, and CE Mark earlier this week. So looking forward to bringing those out to both of those markets in the United States and Europe over the next couple of weeks, as supply becomes available. And then later on this year we’ll look for other opportunities such as in Japan to launch as well.
TS: And do you have some other approvals pending? Do you see yourself going into other markets after that?
JA: Without a doubt, yeah. So this certainly will be a global launch. I think we’ll certainly be prudent and make sure that we do the right things by our customers and make sure that we internally are ready. But we have every intention of making this a global launch in the future.
TS: Hi, we’re going to take another quick break here just to again remind you to go to OIS.net to check out the agenda for OIS@AAO. It’s shaping up to be great. We’ve got a bounty of great companies that have applied to present. So it’s going to be a great year for company presentations at OIS@AAO. And of course, none of this happens without our sponsors, and I’d like to take a moment to thank your premier sponsors, Allergan and Shire, for their support of OIS@AAO. It’s great to work together with these great companies to make sure that ophthalmology innovation gets the attention it deserves. Now back to this conversation.
TS: I’m going to take a look at Oculentis’ booth. They’ve had lines going around the block all day, so they must be serving up some exciting new technology. Hi. What are the flavors?
Oculentis: Mango, licorice, chocolate, and vanilla.
TS: Chocolate, please, and a little bit of vanilla.
TS: Yes, ice cream. One of the better promo ploys of ESCRS. Let’s talk to Oculentis.
O: Actually we are manufacturer of the Lentis intraocular lenses, most famous are Lentis Comfort and Lentis Mplus Segmented lenses. And here we are mostly at every year the ESCRS, and here at the moment because it’s so warm in the exhibition halls, we have ice cream. Ice cream and coffee.
TS: Very smart.
O: Yeah, it’s working. I mean it’s a long line. I mean mature surgeons are standing in line for 20 minutes to get one little bowl of ice cream. But you know, it’s nice.
TS: You have the two hours bringing people in.
O: Yeah, it’s crazy. It’s really crazy. But we are happy, happy it’s working, happy they are forced to stay in line to see our slogan everywhere. So it’s great. Oculentis is happy so far.
TS: Great. Well, thank you for the ice cream.
O: No problem. Enjoy.
TS: Thanks to Enrico Plessow, head of marketing at Oculentis for taking a few minutes. He said that Oculentis does not have lenses available in the US, that the FDA, unfortunately, is too big a hurdle. But he went over their line of products that are available in Europe and beyond. And go to Oculentis.com and check out what they have. And if you have an opportunity to get some ice cream next year, please do it. It was delicious. One of the keynote addresses at EuRetina was given by Professor Richard. In his talk, he outlined the potential groundbreaking technologies, or the groundbreaking potential of technologies like stem cell therapy and retinal implants. So we had a chance to speak with Khalid Ishaque. He is the CEO of Pixium Vision. Pixium recently received CE Mark for its Iris II technology. And we talked to Khalid about what his plans are for the company following that approval.
TS: Quick editor’s note: I did talk with Khalid for over 40 minutes. This is going to be an edited conversation. Perhaps we’ll play the entire interview in a future OIS Podcast.
TS: Well, why don’t you give us an introduction to Iris II?
Khalid Ishaque: Iris II, right. So we are here for the first time after the European commercial approval, which came end of July for Iris II, which is a 150 electrode epiretinal device with additional feature that it’s designed to be explantable as well as you see here. The goal is very similar to epiretinal technique is to place the electrodes on the surface of the retina to stimulate the ganglion cells. But the technique, which has been developed by Pixium with the Iris technology, is to – very first step is to place the retinal tack, which is different to what has been done so far. We attach and suture the extraocular housing, insert the electrode array with 150 electrodes on top of that retinal tack, and secure it in place with this retainer ring, which is silicone. And in case we need to explant or in case new technologies come about, the goal why – how this has been designed is to remove that silicone ring, just remove the implant, but leave the tack in place. And that technique has been patented. This has been going on for design since the Iris project stated by IMI in German. And so we’ve taken from 49 electrode Iris I now to 150 electrode Iris II with CE Mark, while the clinical trial is still running to develop longer term efficacy data for this device. So I’ll show you just a little bit, quick demo. The other key difference here: we are not using a regular video camera. The goal here is to be able to capture what changes in a visual scene. So this is a bio-inspired image sensor which mimics the functioning of the human retina, in fact. Every pixel is independently looking at a scene and looking at the changes in a visual scene, whether the change is in luminosity, whether change in brightness or contrast or movement. Those are the only things the sensor is interested in, and the technology actually comes from the technology which was originally developed in Zürich for the Large Hadron Collider Project. So the researchers thought about how do we integrate that to really mimic the functioning of that. We think that one – there are two advantages of that. One, battery consumption. You don’t need to be capturing a lot of redundant information from a video camera, and then down sample in order to convert to electrical signals and then stimulate the retina. Here we are taking directly the useful information, what the patient is interested in in real time, and use that to generate the stimulation commands. And we think that might also be a language which the brain in general is interested in receiving. The brain is not interested in redundancy because it relies on memory for that. So if nothing behind my head changes, your brain is getting nothing to conserve oxygen. But if I move my hand, yes, that’s new information. So brain is – so that’s why we think bridging the eye and the brain through this integration of one more electrode to try to give higher resolution and more intelligent way to send the signals to the retina to stimulate the ganglion cells.
TS: How important was the keynote address yesterday, in which retinal implants were highlighted, along with stem cell technology? Does it help get physicians on board with this idea? Are they generally open to introducing this to their patients who, you’re right, have no other options? How important was the keynote, and what is the overall receptivity of physicians?
KI: I would say overall, there’s from a few years ago with the hype around the retinal implants, because people started seeing the very first results because the results with implant technology tend to be obviously more short term, versus gene therapy or stem cell research, which is going on. So the keynote lectures, even at ARVO this year, there was not a lot of talk in May about retinal implants because people are looking at what else is possible. They’re more looking at restorative, earlier stage interventions, whereas the retinal implants today are positioned as kind of last resort when nothing else has worked. Now you are blind; what do you do? So people often get confused. These are not competing efforts today. But from a factual point of view, today there are only 3 retinal implant companies now. That’s an approved technology. Regulatory approval in Europe for 3, one in the US. And while all the other research in stem cells or gene therapy is still in early phases of phase 1, phase 2 studies, and they still have to prove long term efficacy. And we hope it will work for patients intervening earlier. So the keynote was interesting to – we just see the newspaper this morning. Although Professor Richard’s lecture was almost half of his time was spent on retinal implants, in the actual write-up, it seems very clear two-thirds of the write-up is about gene therapy and stem cells, and there’s only a paragraph about retinal implant technology, which is interesting. Now, being human, and a lot of the journalists like yourself also, when they see the results, feel is this it? Is this all they can do? But they often forget where these patients are coming from. So and we will continue to try to improve the benefit for these patients and quality of life while the rest of the science, the biology, the biotech and the pharma industry looks for finding cures, which is the dream of everybody. One day we will find cure for blindness. But today we are just providing quality of life improvement in the lifetime of people who have nothing else. Until now, there was nothing available for them. Today you have an approved treatment now available for them. Does it provide perfect vision for them? No, not yet. So it will be interesting to see how everybody’s hoping for better results before physicians really recommend. I think the world is divided a little bit between there are people who are more in stem cells and gene therapy research, and they are of course a little bit biased towards well, this is good, but not good enough. Let’s focus – and NEI has its own audacious goals to really try to regenerate the retina. But there are other very pragmatic doctors who say, Well, what do I do with my patients who are coming to me today? So we’re glad that we are able to be of help with the technology, and we’re carefully selecting the patients who will benefit from their day to day and get more independence. And there are people who are uncertain. And retinitis pigmentosa is a rare disease, and there are different stages of the disease, and we don’t want to put people through taking risk of whatever little vision they have left. So there are very strict criteria of when people can actually have a retinal implant. So we’ll see kind of two worlds: implants, very pragmatic, what can we offer our patients today, and continued improvements; and then the gene therapy, stem cells, which are more down the stream, which will require earlier stage interventions to either slow down or recover the loss of retinal cells.
TS: And I do want to get into the CE Mark. You obtained it in July, correct, for Iris II? What does that allow you to do? What are your next steps? Are you going to need more money? Are you going to have to hire folks to sell?
KI: Yeah. So the CE Mark in Europe allows the company, having demonstrated the safety primarily of the device, which is based also on the previous version of the device, allows us now to start commercializing. It doesn’t allow necessarily immediately reimbursement for the device everywhere because we still have to negotiate that. And there are high technology special reimbursements available to start introducing the device with the criteria for long term efficacy data buildup. So there are conditional for such chronic treatments for a small company without the funding to actually do long term studies. I think that’s going to be very helpful in France, in Germany, in UK to allow us to at least start commercializing while in parallel we can do efficacy data, which will require us to have, of course, now commercial team direct in Europe to start introducing in some specialized centers where the retinal surgery wall be performed, but also the re-education capabilities because it requires quite a significant effort from the patient and the low vision specialists to teach them how to interpret on this artificial vision. The surgery itself is 2, two and a half hours, but the patient has to still learn. So this is not a surgery for every center if they don’t have a follow up support for the patients after they’ve been implanted. So this will allow us to start commercializing in Europe or anybody who follows the CE Mark regulatory approval process to be able to buy the device, if they can, or through the national health services to negotiate what and when will the reimburse. So that CE Mark allows us to now start filing for reimbursement approvals in select countries and then start supporting the implant and the beginning of commercialization at centers of excellence who have been trained to already perform. So we have – now we are across 5 European countries who have approved the device for participating in the clinical study for post-market, long term follow-up. UK, Spain, with eminent centers of excellence, four centers in Germany from Hamburg to Bonn, Freiburg, and hopefully very soon Munich. Moorfields, one of the world’s most known centers out of London has started. The Institute of Macular Ocular Specialization in Barcelona, IMO, will be participating also. So in parallel, while we’ll continue to study the device, we will also be able to offer the device at these centers for patients who are interested to participate, to have access commercially to be able to pay for the device either through private pay or through other financing while the governments go through the reimbursement processes for this system.
TS: In addition to meeting with the companies on the exhibition floor, we did get to take in some sessions. On Saturday, one of the main sessions was right up our alley, called Novelties and Late Breaking Developments in Retina Technology. Among the presenters were Mark Blumenkranz, an old friend of OIS, of course, and Pravin Dugel. He co-chaired the event and gave an update on OPT-302 that was really much anticipated by the attendees. Also found a presentation by a Doctor Claire Bailey of the UK. Interesting. She talked about macular atrophy. We’ll talk first to Pravin Dugel, and then my quick interview with Dr. Bailey.
Pravin Dugel: I think the main thing was essential to their advances that are going on in the surgical field as well as the medical field. And I think from a medical point of view, I think we’ve reached sort of the plateau of what anti-VEGFA monotherapy can do. So I think it’s quite clear that we’re about to take the next step, which is probably going to be combination therapy. And from a surgical point of view, I think what became clear was that there are surgical approaches to some what we call medical diseases, such as retinitis pigmentosa and dry macular degeneration, but also that our next surgical revolution may be better visualization, maybe digital visualization and informatics to layer on different multi-modal images so that our surgeries can be much more effective and safer, much like GPS would be, for instance. So I think those are the main things from the session.
TS: And you presented the OPT-302 data.
TS: That had some excitement. People were eager to wonder when that’s coming out.
PD: Right. Well, it’s in a phase 1 study right – oh, the phase 1 study is completed. So the phase 2a and 2b study will be ongoing. And if the data is as encouraging as the phase 1 study suggests, then I think it’ll rapidly move onto the phase 3. At this point we’re still gathering data and going through the process.
Claire Bailey: Well, in summary, what we did was we looked at how much atrophy there was in people who were given anti-VEGF treatment. It was one of two different drugs, and different regimes, continuous injections versus discontinuous injections. And what we looked at was how much atrophy was developing within the lesion, within the CNV over time. And we found that actually the amount of atrophy within the lesion did not relate to which drug was used between bevacizumab and ranibizumab. And it did not relate to the number of injections that was given, either. Which is sort of reassuring, because people were worried that lots of injections might induce more atrophic change. Now it’s still – they jury’s out yet as to quite what effect the anti-VEGF treatment has. And we have another study called IVAN II, which is collecting data with a longer follow up. So that will give some more information. But those are the sort of take-home messages. We also find that a particular type of CNV, predominately classic CNV, seem to be associated with reduced progression of atrophic change. We don’t know. It’s very intriguing thought about why that might be. We don’t know. And also that a tiny bit of subretinal fluid at the final visit seemed to be a relatively protective factor. Again, we don’t know the reasons for that, but that was within the statistical analysis.
TS: So what’s the next step for you?
CB: Next step really is we’re very interested to look at the longer term follow up data from our IVAN II study. So we will have several years of follow up on these patients, and we want to see whether the atrophic change continues to progress over time, and we’ll also look at the various factors about which drug they had, which regime they had in the first 2 years to see what effect that had. Now after the 2-year study, patients went on to normal treatment regimes, so they’re not such a pure group. But it will still be interesting to see what happens.
TS: Thanks for the time. Well, while a lot of the activity happens inside these four walls, or I don’t know how many walls there are at the Bella Center, a great deal of the talking and the deal making of course goes on outside of here. And we’re going to talk with a CEO who is not taking part in the ESCRS yet because he’s not commercial just yet, but certainly is finding valuable opportunities to further his company’s goals.
TS: This is Tom Salemi. I’m here at ESCRS, where not all of the activity is happening in the halls of the conference center. I’m here with David Bailey, CEO of Sensimed. And Sensimed got FDA approval for its contact lens sensor in March, but Sensimed is pursuing many different avenues before a commercial launch. David, let us know what is Sensimed up to since you got that FDA approval in March.
David Bailey: Well, we were delighted to get that first of a kind of approval from the FDA. We’re the first ever contact lens sensing device that’s measuring volumetric change, which we’ve shown in many peer reviewed articles is very relevant for the assisting in the diagnosis and treatment of glaucoma. Going forward, we just closed a financing round in order to enter into 2 significant clinical studies to validate and build a model around clinical utility with regards to two elements. One will take place in Japan, and will be focused on classifying NTG patients. That’s the dominant element of glaucoma in Japan. We partnered with a strategic player to help us do that and to finance that clinical study. And we have very strong support from the Japanese Glaucoma Society who are endorsing the study and will start moving that forward in November.
TS: What are the challenges in particular in diagnosing that type of glaucoma?
DB: In Japan, normal tension glaucoma, 8 out of 10 patients are diagnosed that way. The normal gold standard, which is pressure, is not elevated in those patients. So they can’t just use that biometric to categorize those patients. So they’re really looking for an additional clinical parameter to use, and we’re hoping that the volumetric change of the eye over the 24-hour period, which is what we measure with the Triggerfish device, can be a classifier. We had a couple of peer reviewed articles published which seemed to demonstrate that. This clinical trial is about validating that. The other element of clinical utility that we’re going to be focused on is using the Triggerfish profile to categorize patients as either fast or slow progressors. We had an exciting, first of a kind study that was published in Ophthalmology a little bit earlier this year that demonstrated that element of clinical utility. So based on the Triggerfish recording, that paper demonstrated that you were able to classify the patient as either a fast or a slow progressor. It’s our aim to move forward with a similar study in the US market that would lead to validation of that concept, and also reimbursement for the Triggerfish device. So in that regard, we’re actually looking for a strategic partner in the US in order to partner with us at this early stage in order to do that study and demonstrate this element of clinical utility. So exciting times for Sensimed. I get strong endorsement from the glaucoma professionals that they’re looking for an additional diagnostic tool to supplement and compliment their IOP measurement. Sensimed is not trying to replace IOP; we’re trying to add in an additional significant biomarker in order to allow them to better diagnose the patients and ultimately check on their treatments to make sure that those are effective.
TS: And you mentioned the contact lens technology could be a sort of platform. Are there other opportunities for Sensimed down the road? You’ve got a lot on your plate right now with glaucoma, but what’s the long term vision?
DB: Yeah. We’re the first company to have a contact lens with a sensor in it and a telemetry system that can record over an extended period. It’s perfectly possible and feasible for us to put other sensors into the contact lens in order to broaden the reach in other diagnostic areas. The obvious choice would be a pressure sensor to measure 24 hour IOP directly. We’ve already done that and tested a device in Asia, learned an awful lot from that. And we can put other sensors in. So it’s a platform technology. Obviously we’re very focused on this clinical utility aspect. We’re going to be driving that forward very strongly over the next 18 months to two years. But we have a nice technology that we can broaden the applications. But that’s for the future.
TS: And we hear so much about the potential for contacts, obviously Google’s famous attempt at the glucose sensing. Where that goes, no one knows. But this is clearly an area that’s ripe for opportunity for startups and larger companies alike.
DB: Yeah. I mean I joined Sensimed because of my interest in contact lens sensing. I’ve been involved in a company with a glucose sensor some time ago. And I think it’s very clear that contact lens sensing is going to evolve and be quite significant over time. So for Sensimed and for me to join and get a first of kind of approval within that 18-month period is really exciting for the company. I think it’s exciting for ophthalmology, and as we’ve just shown with this financing we did, it has the ability to pull in new players to the market. We’ve partnered in Japan with SEED, which is a significant disposable contact lens company. And I think that’s good for ophthalmology that we’re pulling in new companies who are not currently in this space. So I think the future is going to be interesting for contact lens sensing.
TS: Well, I hope you have fruitful meetings here at ESCRS. Thank you, David.
DB: Thank you so much.
TS: And finally, just prior to ESCRS, I had the opportunity to speak with Dr. Klaus Stockman. He’s the managing partner, or a managing partner at Peppermint Venture Partners. And Peppermint, of course, has a few portfolio companies in ophthalmology. I talked with Klaus about those companies, and also about what other opportunities Peppermint sees in the sector.
TS: Klaus, tell me a bit about Peppermint Ventures. How large is your fund, and how big a role does ophthalmology play in that?
Klaus Stockman: So we’re managing two different funds. The total volume is about 50 million euros, and we’re investing in medical devices and digital health. Company is based in Berlin, but we’re investing Europe-wide. And one of our main focus is ophthalmology. We have two portfolio companies in the fund. One of them is Implandata, glaucoma monitoring with the first intraocular eye pressure sensor. And another company is Caterna Vision, which has developed a software as a medical device for treating lazy eye.
TS: what is it about ophthalmology that you find most appealing? We can go over the various positive elements about it, but what is it about ophthalmology that Peppermint finds most appealing?
KS: I mean very interesting is that there is still enough unmet medical need to find solutions for. That’s also a reason why last year we sponsored an eye accelerator in Berlin. Maybe you’ve heard about that. EyeFocus. It was sponsored by Bayer, by Zeiss, and by us, creating 80 deals from all over the world to look at, so the innovation capacity in ophthalmology is something which is really intriguing for us.
TS: And I’m really impressed by the critical mass of meetings here in Copenhagen. You have ESCRS this weekend, a glaucoma one tomorrow. There’s a few others in various hotels. It’s almost becoming like a JP Morgan for ophthalmology. Is it just happened that there’s just this confluence of meetings at this time? Or is ophthalmology really gaining a lot of traction – it’s already had traction in Europe, but is it getting more traction in Europe?
KS: I think the later, I think it gets more traction. We have more and meetings in Europe, and I think this is a great venue for meeting the corporates, meeting venture capitalists. Also have to say I haven’t seen too many today, but maybe tomorrow and over the weekend you will see more. So it’s a great platform to network.
TS: What I find interesting is the regulatory matters obviously aren’t stated as much of a hurdle here. This seems to be more of we’re getting this out on the market. That’s gotta help sort of foster innovation and encourage people.
KS: Well, I mean yes. You know the regulatory environment is basically adopting, adopting mostly likely more to the US and in another direction. If you have a class 3 medical device in ophthalmology, you also have to undergo extensive clinical testing and safety in Europe, meanwhile. It’s not so easy than it was, let’s say, 2 or 3 years ago.
TS: But as someone had stated, if you don’t have a plan to get in the US, we’re probably not going to invest in your company.
KS: Oh, I see that point. Yeah, of course. As a VC, we always, as a European VC, we start investing in Europe and building the company here in Europe to get a first CE Mark, like Implandata is close to get CE Mark for their intraocular device. But at the same time, they had discussion with the FDA, and we know exactly what we have to do to bring the product in the US market.
TS: Are you looking for deals in ophthalmology? And are you looking more in Europe or the US? Will you invest in either?
KS: Well, we would invest everywhere, but to be honest, if possible we want to like to bring the technology to Europe. So also Implandata has acquired large inroads into the US with key opinion leaders, but the technology was developed in Germany, and the clinical trials were done in Germany. But I think we will soon start also clinical trials in the US.
TS: And going back to the accelerator for a moment, we’re seeing great success in the US with ForeSight. They seem to be creating a lot of success stories. What sort of production are you seeing from the Accelerator here? Obviously it’s very early; I’m not looking for exits. But do you have some stories you can tout at this point?
KS: Well, I think you should also ask the corporates who also sponsored him, but from a VC perspective, to be honest, it was fun because there were investment opportunities and projects all over the place from Africa, from Nigeria, from South Africa, from China, from Hong Kong, from the US. All the people who came to Berlin to build their ideas. What I was founding interesting is that well, a lot on blind people. So blindness for whatever reason was a major topic, which as you probably can know is a hard investment hypothesis to invest in a solution for blind people because of actually its scalability of a product. So but in essence, it was a great networking. And for Europe, or Berlin, it was great to bring in international people, bring in the corporates, and then network. I think the inventors or the entrepreneurs having been there, they profit most about the creation of network and the input on their development.
TS: Last question: what has you most excited about ophthalmology over the next 4 or 5 years? We’ll seeing a lot of traction in MIGS, some areas really starting to get hot. Do you have a sense of what other success stories we might see in the next couple of years?
KS: I have two things. I’m really a hard believer that on glaucoma you need a monitoring device to measure pressure. And that’s the reason why we like Implandata so much and we invested in it because I think this will transform glaucoma therapy. That’s the one thing. And I think other devices will come, and that will be implemented in the next 10 years as a natural thing to have a sensor measuring the eye pressure. The other things we are really hot on is the whole digital part of ophthalmology. I think digital therapies or digital solutions for diseases in the eye will come, not only companies from ours like Cartana, but you have other companies which are using stimulation therapy for AMD, for other diseases, which you think today, well, how can that work? So we’re really excited about the whole digital component when it comes down to Ophthalmology.
TS: Well, thanks for joining us today.
TS: All right, everyone. Thanks for joining us on this wild ride. This is the first time we’ve taken the Podcast out on the road. I’m actually – if you’re wondering how I’m going this, I’ve got a hand-held microphone that’s connected to a digital recorder, and I look kind of like a dork, but it works. And I got some great comments from some great folks in ophthalmology. Thanks again for everyone who took the time away from their busy, busy days – I know this is crunch time for folks in this industry – to share their thoughts. We had some interesting talks about financing, about commercial roll outs, about new research and new studies coming down the pike, and about promising new technologies that aren’t commercial yet. So much going on in ophthalmology as we know that, and you’ll find out more about it at our upcoming OIS@AAO. Yes, that’s right, we’ve got our own conference to tell you about. Go to OIS.net to register for OIS@AAO. It’s happening on October 13 in Chicago. And it would be great to see you there. Last year’s, if you remember, was a blowout affair. And we’re expecting strong members this time as well. So please join us. Go to OIS.net, register for the October 13 OIS@AAO and we will see you in Chicago.