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This OIS Podcast brings a bit of OIS@AAO to your laptop and smartphone. Hear from a few of the leaders in ophthalmology including executives from Allegro Ophthalmics, Avedro, LacriScience, Ocular Therapeutix, Opthea, and Sightline Surgical.
Tom Salemi: Hey, everybody, this is Tom Salemi. I hope you’re all recovering from the weekend at AAO, and I certainly hope you started it off right with us at OIS@AAO. We held our fourteenth OIS. It was at the Hyatt Regency Chicago, and it was terrific. We had over 900 people show up, and it was a great day of presentations and panel discussions, as I discussed previously with Emmett Cunningham. We mixed the agenda up just a bit, and heard a lot of rave reviews from folks. So very grateful to everyone who participated. Thank you again to all of our sponsors who helped make it possible, and of course a big congratulations to the Healthegy team and our co-chairs, Emmett Cunningham, Bill Link, and Gil Kleiman. It’s great to have such terrific leadership in putting together this type of event. And we want to bring you some content from the event. If you missed a portion of it, if for some stranger reason you just couldn’t attend, or for some legitimate reason you couldn’t attend, we’ll be delivering the content to you in your inbox. If you want to see the content as it comes out, my best suggestion is you go to OIS.net and sign up for the Eye on Innovation Newsletter. We’ll make much of the content available through those channels, and you’ll also be eligible to receive our other content-related, OIS@AAO related content as it comes out. And we’ll be churning that out in the coming weeks, including some great private interviews I had with some of ophthalmology’s leaders including Gavin Herbert, David Pyott, Ashley McEvoy, Bob Dempsey, Jim Mazzo, and Vince Anido. So it was a very, very productive day and a very enjoyable day for me. And I hope it was for you as well. To hold you over until all that great content comes down the pike, I’d like to present you with this Voices of OIS podcast. Perhaps we can call it VOIS. No, that would be stupid. Mario won’t let me keep that. So we’ll just say Voices of OIS and in addition to those interviews that I had with the folks I mentioned a bit ago, I talked to more than a dozen companies about the news that they delivered at OIS, and also just got some updates on their companies overall. So we once again will make those interviews available to you – they’re video interviews – through our email channel. So do sign up for the Eye on Innovation Newsletter. But I wanted to give you a snippet of some of those conversations in this Podcast. First, we had the opportunity to report some news at OIS. I talked to Amar Sawhney. Early in the day – Amar Sawhney, of course he’s President and CEO and Chairman of the Board of Directors for Ocular Therapeutix. Earlier in the day, Ocular Therapeutix reported a new agreement with Regeneron. We’ll talk to Amar Sawhney about that deal, and then we’ll get into a few other news breaking elements from OIS.
TS: You had some exciting news this morning. You had a release you’ve got a new arrangement with Regeneron. Can you bring us up to date?
Amar Sawhney: Yeah. Really exciting development, something that we’ve been working on for some time with Regeneron on. And what we announced today is that we are entering into a collaborative option and license agreement with Regeneron directed towards developing an extended release formulation of aflibercept or Eylea. The hope is that this collaboration will be able to advance a product which could release Eylea over 4 to 6-months duration, an extended duration, relative to the shorter duration that the injections right now have, and will enable less frequent injections, and potentially even alleviate some of the side effects that are known with frequent injections.
TS: So you said an option. An option on this particular product?
AS: Right. It is directed towards the anti-VEGF mechanism.
AS: So as you know, our technology can be applied for a range of different applications for protein based, anti-VEGF mechanisms. This collaboration is structured. For other mechanisms that are not anti-VEGF based or small molecule based, including anti-VEGF, we can develop those ourselves or with other collaborators. But Eylea, as you know, is a hard to beat drug. It’s really done an excellent job and Regeneron is an excellent collaborator. Very scientifically minded company, a good partner.
TS: Had you been working with them before?
AS: We had been working with them for about two years informally, and developed a good rapport with their team, and over time we decided that this collaboration should be taken to the next more meaningful level.
TS: Next we talked to Monty Montoya. Monty’s been a stable at OIS, of course representing SightLife, which has done a great deal of great work in corneal transplants. But Monty was there to talk about a new venture that he is involved with. He’s now CEO and President of SightLife Surgical. And Monty will give us the details right here.
Monty Montoya: We recently closed on the series A financing of SightLife Surgical. That round was done by Flying L partners, which is led by Bill Link. Many other great people in the ophthalmology industry are behind Flying L, people like Andy Corley, who’s had a great impact in our space. And so we’re excited to be here at OIS to announce the creation of SightLife Surgical, the funding of Sight Life Surgical, and now get into the work of actually growing that organization and creating benefits for surgeons, benefits for patients, and benefits for the investors.
TS: Terrific. How does SightLife Surgical fit into SightLife? Where is the connection?
MM: Yeah. And so the main process of providing corneas for transplant is the recovery, processing and distribution of those corneas. SightLife Surgical is going to take on the processing and distribution portion of providing corneas for transplant. SightLife, the nonprofit, will retain the recovery portion and the global development portion of what we’ve been doing. And in the context of providing surgeons their corneas for transplants, SightLife Surgical will become all about the cornea, beyond just the tissue for transplant. We’ll continue to grow and add new and better products for surgeons who are doing cornea transplantation, and also advancing other cornea therapies.
TS: Excellent. And how does this help you reach that 2040 goal? This just creates efficiencies, or will encourage efficiencies that will hopefully get you there?
MM: Well, the key to getting to a point where we clean up the gap between the 150 million a year supply of corneas and the 10 million people in demand of cornea transplants and other cornea therapies is really innovation. And so Tom, what we’re doing is we’re getting the resources in place, we’re getting the right people in place so that we can actually innovate at the speed of need in cornea. And that innovation will allow us to reach populations, not hundreds at a time, not thousands at a time, but millions at a time.
MM: So that we really do get to that goal of eliminating cornea blindness by 2040.
TS: Excellent. Well, it’s – grateful that you introduced the news here at OIS and brought it to our audience, and thank you for taking some time to tell our viewers on OIS TV.
MM: Thank you, Tom, and I have to say this environment really, I think SightLife Surgical is a great example of the benefits that come out of OIS because the networking we’ve done here, the learning that we’ve done here over the years put us in a fantastic position to actually make SightLife Surgical a reality. So thank you to you guys.
TS: We talked to David Bailey when were at ESCRS last month, and he gave us an update on Sensimed. At his presentation at OIS, David released some information about a new financing agreement. It wasn’t a fundraising, but it was an extremely healthy amount of debt, and it came from a very interesting player. Let’s have a listen.
David Bailey: And we also announced that we closed a 10 million convertible loan. First time we’d announced that –
DB: – of which half came from Seed, and Japanese contact lens company that wanted to get into the device space. So Seed came in with half of those monies. Our investors came in with the balance. And a portion of what Seed put in will be dedicated to doing a key pivotal study in Japan on using Sensimed Triggerfish as a classification device for normal tension glaucoma.
TS: Well, let’s talk about Triggerfish.
DB: Two new, exciting announcements, first time at OIS.
TS: Thank you for sharing them at OIS. Love to break news here. Let’s back up a bit and introduce Triggerfish as well to our viewers out there.
DB: Right. So Triggerfish is the first FDA approved contact lens sensor. So we have a sensing mechanism inside a silicone contact lens with a telemetry system so that we can record ocular volume change. So there’s a strain gauge sensor inside the contact lens, and we measure the change in ocular volume over a 24-hour period, so that we get an uninterrupted look at what’s happening while the patient is asleep at night. So we get a full 24-hour measurement of something new, ocular volume change, which we’re now focused on understanding the clinical relevance of that measurement, and how it can be used to supplement IOP measurement to give better treatment for patients.
TS: So is it clear that we need that second metric? Is it evident to you that that’s necessary?
DB: Excellent question. If you go to Japan, I think this is the key test. In Japan, because 97% of their patients have normal pressure, just measuring pressure alone for glaucoma diagnosis is not sufficient.
TS: Oh, interesting.
DB: They’re desperate for an additional biomarker that they can use to supplement their IOP measurements in order to classify the patients more precisely, and therefore decide treatment.
TS: Next, I talked to Reza Zadno. He’s the new CEO, of course, of Avedro. We talked to Reza at ESCRS last month as well, and we were also joined with Raj Rajpal, who’s the CMO of Avedro. And Avedro had released – after I talked to them at ESCRS, they had released some very interesting studies regarding PXL, its promising new treatment for vision improvement for low myopia. Let’s hear this conversation with Reza and Raj.
Reza Zadno: So PXL is photorefractive, intra-stromal cross-linking, as you know. It comes from an understanding that focally cross-linking a portion of the cornea allows the remainder of the cornea to adjust shape, and that allows us to achieve flattening, which is what we’re studying right now in myopia. So this is using a device and a formulation of riboflavin that’s not available in the US, not in clinical trials in the US, and the two studies that you’re referring to, one was an epi off study, where we removed the epithelium, soaked the riboflavin, and then applied the UV light. And we found a treatment effect of about 1.3 diopters. And the second study was the epi-on study, where we expected less effect, but were able to achieve about .75 diopters. So it’s promising because we are performing a very non-invasive, or minimally invasive procedure to correct a low level of myopia.
TS: That’s terrific news. And where do we go next with PXL after the release of those studies?
RZ: So we have ongoing clinical trials that are evaluating various parameters that we think will allow us to increase efficacy as well as refine the algorithms to be able to achieve the treatment effect that we want.
TS: Terrific. And now we’re also in the middle of a – or the beginning, rather, of a commercial launch of KXL and corneal cross-linking.
TS: Can you give us an update on that?
Raj Rajpal: So we started shipping a few weeks, and we are very excited about it. Our goal is by the end of the year to have 200 systems in place. That’s going very well. So that has been one of the activities at Avedro, expanding our manufacturing. So we are bringing – moving to a new building and hiring people. So that’s going very well, as well as continuing shipping product outside the United States.
TS: Let’s stick with the clinical trial updates. I had a chance to speak with Megan Baldwin. Megan has been on the Podcast before, also has been interviewed for OIS TV. She leads Opthea, which is an Australia based company that does its clinical trials in the US, and we’ll get into that in a minute. Opthea is developing OPT-302 as a treatment for wet AMD. It blocks the activity of VEGFC and VEGFD. Megan gave us an update on the clinical trial progress for OPT-302. Let’s have a listen.
Megan Baldwin: Yeah. Well, we’re an Australian based company, but we do all of our clinical trial work in the United States at this point. We’ve recently reported data from our first in man clinical study. It’s a phase 1 dose escalation study. We showed that OPT-302 in wet AMD patients was very safe and well tolerated. But in addition to that, we saw very early the very encouraging evidence of clinical activity of OPT-302. So we saw improvements in visual acuity and reductions in retinal thickness that were over and above what we would expect with Lucentis alone. So we’re very encouraged by that. And in addition to demonstrating some interesting data in naïve patients, we also showed some evidence that we’re able to improve outcomes in patients that have been treated with a VEGFA inhibitor previously.
MB: So they’re generally regarded as a difficult to treat patient population, but we saw some very interesting improvements in visual acuity and reductions in retinal thickness in those difficult to treat, prior treated patients.
TS: Now I’m accustomed to seeing US companies doing their trials OUS. Why are you doing your trial in the US?
MB: We’re doing our clinical studies in the US in order to basically work with the leading clinical sites, the leading clinical ophthalmology experts. We’re also able to access the very large patient numbers that you find in the United States. But it also enables us to interact in that global fashion with really some of the leading clinical experts in this field. And we think that’s important. As we move through our clinical development program, we’ll be expanding our global reach, so we’ll be doing more clinical studies, both in the AU as well as in the Australian sites as well. But for our initial study, we really did focus on the FDA and doing our sites in the US.
TS: Let’s stick with the clinical trial updates. On the day of OIS, Allegro Ophthalmics very kindly released the results of its DEL MAR phase 2B clinical trials. These are evaluating Luminate as a treatment for patients with diabetic macular edema. I had the opportunity to speak with Vicken Karageozian. He is the President and Chief Medical Officer of Allegro, and gave us a sense of exactly what these trial results mean for the company. Let’s listen to what Vicken says.
TS: OIS is a time when we break some news and you were kind enough to deliver some news this morning.
Vicken Karageozian: Yes, we had a press release this morning that our phase 2 DME monotherapy study came out successful, met its primary and secondary endpoints.
TS: So what does that mean for Allegro? What is next?
VK: What it means for Allegro, first of all, what the news today meant was that we’ve taken a lot of risk out of the equation, that in 140 patients followed for 6 months, the drug can stand on its own against anti-VEGF, by itself, and give you nice improvements in visual acuity and retinal anatomy that are comparable to what you see with anti-VEGF, with a completely unique mechanism of action. We actually had a bonus as well. After giving the drug, the drug seems to last about 12 to 16 weeks after the last dosings as well.
TS: Terrific. That is great. Backing up a little bit, just tell us a little bit about your technology and your approach.
VK: Yeah. So Allegro’s leading molecule is Luminate. It’s an anti-integrin peptide. It’s a synthetic peptide. It’s the first in class in ophthalmology, doesn’t exist inside ophthalmology right now. It targets the construction aspects of angiogenesis rather than the signaling pathways, like you see with VEGF.
TS: So the phase 2 trials obviously will be helpful if you were to go in phase 3 by yourself.
TS: But this is also a nice time to talk to partners and –
VK: That’s exactly what’s happening already. The amount of interest since this data has come out over the last few weeks has been pretty intense. Things are moving forward pretty quickly.
TS: That’s fantastic news. So maybe we’ll have some news sooner than OIS@AAO next year.
VK: We’ll see.
TS: And finally, let’s visit with the principals of LacriScience. Chris Geddes and Paul Gavaris were kind enough to stop by and give us an update on the LacriPen, which is a device that’s been developed as a hand-hold tear osmometer, used for the diagnosis of dry eye. But in this discussion, and if you watch Chris’ presentation, which we’ll have up on OIS.net in a bit, you’ll see that the potential for the LacriPen is far greater than that. Let’s hear what he has to say.
Chris Geddes: It was an interesting talk this morning that LacriScience gave because previously we’ve pitched the pen as being an osmometer for the detection and diagnosis of dry eye syndrome. Today, we showed a lot of potential of the pen, but it goes far beyond just osmolarity. We can detect a whole load of different disease states, up-regulated MMP9, adenovirus, MRSA, herpes simplex, herpes zoster, and really it’s the only platform technology that hopefully will be on the market in a few years’ time. There’s no other technology that can diagnose all those different disease states on one pen.
TS: So but will ophthalmology, will dry eye be your principle focus, the thing that’s going to carry you into commercial –
Paul Gavaris: It’s in the – because it’s the first two tests, the osmolarity and the MMP9 that Chris is developing the biofilm. But concurrently, he’s going to be working on the rest of the diagnostic area. So it’s going to be a useful instrument in very short order.
TS: And that’s a wrap. Thanks to everyone who stopped by the OIS TV studio at OIS@AAO last week in Chicago. It was great to have the opportunity to visit with you folks. And many more. We’ll have these videos up on OIS.net as soon as we’re able to prepare them. Thanks of course to our listeners for joining us on the Podcast, and I sincerely hope you were able to join us at OIS@AAO last week. And of course, last thanks go out to our sponsors and our co-chairs, Bill Link, Emmett Cunningham and Gil Kliman for putting together a great show. Once again, we’ll be rolling out content from the conference in the coming weeks. Stay tuned. If you want information on when the content is coming out, or if you want to be sure you see when the content is coming out, please do sign up for our Eye on Innovation Newsletter. Just go to OIS.net, give us your email, and we’ll start delivering you the great news and podcasts and video content from the OIS conference. Thanks again everyone for joining us, and we’ll talk to you next week.