The Outlook on Getting Regulatory-Approved Bevacizumab to Market

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OIS Podcast host Firas Rahhal, MD, of ExSight Ventures and Retina Vitreous Associates sits down with not one but two members of Outlook Therapeutics’ C-Suite staff, Terry Dagnon and Jeff Evanson. We learn about what kind of collaborations and strategies are necessary behind the scenes at Outlook and learn more about the company’s road to bringing ONS-5010/Lytenava (bevacizumab-vikg) – potentially the only Food and Drug Administration-approved form of bevacizumab for the eye – to market. From studies, dosing, pricing, and other considerations, they cover it all. Press play now and listen in on this innovative conversation!

Transcript:

Firas Rahhal: Welcome everybody. Back to the OIS Retina Podcast. Thanks for joining us again, this is Firas Rahhal Partner at Retina Vitreous Associates in LA and also Partner with ExSight Ventures which is centered in New York. I’m delighted to have two guests today. They’re both from the same company. And they’re going to share with us a lot about that company today and their product. Both are people that I know one I’ve known for many years. First, we have Jeff Evanson, Chief Commercial Officer for Outlook therapeutics. And we have also Terry Dagnon, Chief Operating Officer also for Outlook Therapeutics, they’re going to tell us about Outlook. It’s a company that’s bringing branded ophthalmic preparation of Avastin to the market for us something we’ve been waiting for and talking about for quite some time. And I’m going to ask them some specific questions, but mostly broadly about what this will do for us and how they’ve come to this and what we can expect. But first, maybe a little bit of personal history on each of the guys. Jeff, maybe we can start with you. You’ve been in the eye space before, you’ve obviously been in the industry at different levels of commercialization, including I think, at alkine, which is one of our go twos in ophthalmology, as you both know, why don’t you share with us some of your personal professional history in our space or in the biomedical space and how it’s brought you to this point.

Jeff Evanson: Yeah, thanks, Dr. Rahhal, and glad to be here and really excited to share a little bit about not only my background, but about Outlook. I do think or thinking about my background and industry in 2021. I think everybody’s excited to turn the page and we’re almost there and off to other things will mark my 30th year in industry. And as I look back, you know, we have a connection point, Terry and I are very closely at Alcon, as you mentioned, referred to,that was about 10 years ago and I spent five years at Alcon. I ended up being the franchise, Global Franchise Head for the Pharma franchise and so that definitely was the beginning actually of my background in Ophthalmology and Retina and without going through all 30 years. I spent I spent 10 years before then at Medtronic. And there’s a really interesting connection. And I was ultimately leading drug delivery drug device combination products, which was a very big business for for Medtronic. And what was exciting just even getting from Medtronic to Alcon is really the the the pivot that ophthalmology was making with drug device combination products, right. So that that background, they were looking for somebody at Alcon that had that background. And so that’s how I actually transitioned to Alcon, spent five years there, as I mentioned, left Alcon and went into consulting and Terry and I were running different consulting practices, but had a chance to work together and many things still beyond that. And that was really fun to see a lot of the landscape of opportunities beyond what Alcon was even working on. And then joined Alcon, in December of 2018, as you mentioned, as the Chief Commercial Officer of Outlook. And we can share more about that during our conversation.

Firas Rahhal: So what before I get to Terry, and I want him to tell us about his history as well. You’ve been in multiple spaces in this kind of biomedical enterprise. Obviously, the eye has been one of them, and is now again one of them. What if anything about the eye space is attractive or more challenging? Or, you know, if you’ve come back to it, obviously, how do you view that compared to other spaces?

Jeff Evanson: Yeah, and I think that the contrast and comparison against the business I was running at Medtronic, which was effectively neurosurgery and even functional neurosurgery. There are so many similarities between neurosurgery and retina. And the thing that I really loved about that move into retina, the community, very innovative, very collaborative with industry. So many of the things that we enjoy in retina have come from that close collaboration. And I think that what was exciting from Medtronic, I mean, Medtronic, the only thing Medtronic isn’t involved with is ophthalmology, really. And so it was a perfect way of, you know, leveraging a lot of tools that I had acquired in Medtronic being so diverse with pacemakers, defibrillators, deep brain stimulation, drug delivery, many of those active implantable technology concepts apply to ophthalmology. And so again, this that that excitement that the retina community really did embrace a lot of those innovations. And I think so, while a lot of things are new to ophthalmology that are being developed, you know, they’ve been leveraged in other parts of medicine that I think has been really exciting to see.

Firas Rahhal: Yeah, I agree. In Retina, we’re a small space in terms of numbers of doctors around the country, we get to know each other. And we do get to know the people in industry pretty well, a large number of us, and I think it makes for tremendous innovation and development. Because the collegiality is there. We we like each other. Like, I know a lot of you guys on your side of the fence, personally. And I think that really impacts the productivity. I do feel that way. And it’s good to hear that neurosurgery functions that way, as well. Terry, you have been in the business a lot. And I’ve come you and I’ve crossed paths so many times over the many years. And I know about Alcon, there’s others. It looks like you’ve had stints at J&J, as well as this other enterprise Doleman Life Sciences. In the eye business, you’re everybody knows who you are. And you’re a regulatory guru. What, tell us about your history and the sequence and what brought you now to the Outlook program?

Terry Dagnon: Absolutely. So, I spent 13 years of Alcon, and five of which were with Jeff. And ultimately, I was the North America, Head of Regulatory Affairs for the Novartis Alcon division. It was Novartis when I departed, but I did leave and was the General Manager of a Consulting business, that had quality regulatory operations, quality system outsourcing, and a contract manufacturing facility, which really kind of was the next step for me, not just regulatory or R&D, but actually running a business. So the CEO overall, that I now have that Outlook. I was ideally prepared for that. But prior to that, I did work for Johnson and Johnson and it was exciting. I had global regulatory responsibility for wound care, skincare and tissue engineering. Prior to that, I was the ran the regulatory department for what’s now known as US Oncology. It was physician reliance network at the time, so I’ve got an oncology background, topical, but I’ve done 510k products as as you know, some surgical equipment, PA, OTC pharmaceuticals, AMBAs, MBAs, biologics, and quite extensive work in combination products just like Jeff. So the actual product opportunity that we’re working on at Outlook was actually a strategy and an idea of mine. And a number of us came together as a team, and approached a company called Oncobiologics at the time, who had an anti-VEGF Bevacizumab, biosimilar. But was struggling getting funding for the biosimilar programs. Well, they those two ideas coming together was the perfect marriage. And that’s when Jeff and I joined Outlook. And the day we joined, we changed the name from Alpha Biologics to Outlook Therapeutics changed our stock symbol. And we’ve been full speed ahead ever since developing the product that you talked about?

Firas Rahhal: Oh, I want to get into that in some detail in a minute. But before I do, you guys obviously have a lot of overlap in what you do. But there’s also some distinct things each of you do. And I know you each bring a different, you know, skill set to the table, either of you, or both Chief Commercial Officer versus Chief Operating Officer, Jeff, maybe you can start. How do you view the differences? Like what what are this? I obviously there’s overlap, but what are the specific areas that you might be participating within that Terry, does it or vice versa?

Jeff Evanson: Yeah, well, to begin with Terry, and I have a wonderful professional relationship because it’s so symbiotic the work that Terry does, and the leadership he has, and as you mentioned, rightfully his guru status and the things that he does do. My work is in a broad category called commercial, which includes everything from strategy to business development, to ultimately commercializing and running the organization around the selling and marketing of said products is the commercial side of the house. And so my view is that, you know, generally and even when I was the Global Franchise head Commercial Head at Alcon for the pharma business. You know, we had a commercial leader, and we had an R&D and manufacturing leadership. And so Terry, for me, represents you know, that significant other part of the business right of making everything happen so that we have something to strategize around something to commercialize ultimately. And, Terry, I’m sure you could pick up from from that point, in your view of what your role is, and maybe your view of my role.

Firas Rahhal: Yeah, I’d like to hear because this is fascinating for those of us who aren’t full time in this kind of environment to know some of the how the sausage is made behind the scenes that this is educational for me. And for the viewers.

Terry Dagnon: Really, one of the huge benefits is the fact that we’ve worked together for over a decade, five years of outcome. But we shared clients as consultants, as well from two very different organizations, and have chosen to work together for a long period of time. So it’s actually symbiotic. So I take care of running the drug development program for Outlook therapeutics, which means the R&D work and all that goes with it, the regulatory, the quality, and also the manufacturing, which we’ve outsourced. So I manage those relationships, bring all those people together, but to say I do that it’s more or we do that, because every piece of that has Jeff involved, there’s, it’s great to get a product approved, but if it’s not ready to move, and all the other work that’s necessary to launch your product. So we’re partners, we give each other opinions, and we seek each other’s opinions on just about everything. So we’re a very long term team, Jeff, we’ve been working together for over a decade, and it’s very easy to work together.

Firas Rahhal: That’s great. It always comes down. You know, in every, every business, every space, every discipline, it really does come down to teamwork and collegiality. You hear it over and over again. And we hear it over again, because it’s it’s darn true. So it’s a pleasure to see that you started. Terry, talking a little bit about the outlook history. I’m interested in this from either of your perspectives. Not a lot of us knew about this company had heard much about it until very recently, as you said, you know, 2018 a lots been happening now. What is the history of the company? And and I don’t mean to be repetitive, if you’ve already mentioned some of this, but we all know about Avastin and its utility in the space and we’re going to get into that in a couple minutes more in some detail. How did this come about? Like what was the history of the outlet company itself, deciding to go this pathway, what triggered that? Who triggered that if there if there was such an event or events?

Terry Dagnon: So great story, great history. So Oncobiologics did an IPO back in 2015 and was focused on oncology biosimilars. Myself and a couple other partners had an idea and had the initial discussions with the Ophthalmic division at FDA and validated that our strategy was we could get a very streamlined development and regulatory pathway for an approved Ophthalmic Bevacizumab, file it as a new BLA, which comes with 12 years exclusivity which makes it a business opportunity and have the product meet the ophthalmic criteria. Win-Win from the industry side, from the physician side from the patient side. Why? Because we’re solving some public health concerns that are long standing, ever since the compounding repackaging of Bevacizumab as occurred. So we approached and did a deal with Oncobiologics. Part of that was Jeff and I coming on board full time and serving as officers in the company, which we’ve done since November of 2018. And it’s been a great ride, we had a strategy where we conducted trials. And I know you’re going to come to the clinical overview. I’ll stop there. And let Jeff chime in on on the company history and how this really got started.

Jeff Evanson: Yeah, and I think just to add to that, I mean, the the background, I think it also was a bit of a, as Terry mentioned, just the timing was perfect in terms of this strategy and really a pivot going from what was going to be not only a vast and is a biosimilar Bevacizumab for that indication, but Humira as well as a potential and I think the, you know, the capital requirements for that business. And then also just the, you know, when you talk about biosimilars I think what’s not talked about much is that if you end up you could be one of three or one of four in in the space. So what was clear in this really interesting new swimlane that Terry thought about and was is the architect around is this new BLA approach that we get the benefits of being a branded product. And as you say, Dr. Rahhal, you know, a validated standard of care therapy, where we could really bring that idea together while solving some important what we feel are very important safety and potency issues that we’ll probably talk a little bit about, and add this option to the marketplace. So the company really it was just the perfect timing for this idea to be a pivot for the company away from biosimilars into the new BLA area with this kind of hybrid approach.

Firas Rahhal: Yeah, it’s it seems to be a no brainer concept. And when I was first introduced to it myself and met with you guys and heard about the trial, way back when we began, it occurred to me then and occurs to me now. So I’ll ask you, are you surprised? Because I was the no one else has done this. Like, why did this not occur before Outlook took it on? And Terry, you and Jeff took it on. What? Am I missing something? Is there an IP issue? What are the IP issues that relate to this? If any?

Terry Dagnon: You’re correct, so one of the one of the things that had to happen was an IP runway had to run out. So, when we file our BLA, there will be no IP that prevents us from filing as a new BLA and nothing to prevent us from getting approval and launching the product. So there’s that. Also what had to happen was FDA had to sort out the biosimilar regulations. And up until those regulations were finalized, it wasn’t clear how a product like this could get to market. Because as a biosimilar, your label has to match the innovator. So biosimilar of Astons are indicated for the oncology indications exactly what was approved for the innovator product. This is unique, it’s a GMP product. But it also meets ophthalmic criteria, for example, USP 789, for particulates and other things. And it’s going down a new BLA pathway. So two things had to happen. Number one, the patent runway had to run out and the regulations had to be sorted out such that a product like this could come to market. So both those things did happen. And we were the first people to think of the idea. So excuse me, as you now know, it’s it’s quite innovative with a very innovative clinical trial strategy as well.

Firas Rahhal: Yeah, the IP part of it is educational, and it makes perfect sense. But even separate from that I do admire the fact that you guys had to sit down and think about and think of a strategy and do it and, and no one had previously done it again, somewhat surprisingly, but I get the I get the IP part of it. I’m gonna throw a plug for my friends and myself back at the CAT trial days, because I was a PI in that. And I think that was a really, really super important trial. Everyone knows that it was a super important trial. I know you guys do. How much did that factor into this knowing that that data was already out there this well respected? Well, well interpreted data between Avastin and Lucentis at the time?

Terry Dagnon: Well, first, I would compliment as you said, the whole CAT team. very courageous move, courageous study. And one of the things that we love is I don’t have to convince anybody on the planet that Bevacizumab is both as studied in the CAT study, safe and effective for whether the treatment of wet AMD. Obviously our Bevacizumab, slightly different and it does meet ophthalmic criteria. That’s the difference. It’s not compounded. It’s actually GMP produced. We’ve done a phase one clinical pharmacology study showing, bioequivalence to the innovative product. So we’re very comfortable moving forward. But to say that that wasn’t a huge step that led to that this project would be an understatement. The ability the retina community in the current use of compounded repackage Bevacizumab just speaks to the CAT results. And I know Jeff can cover the what is what is the percentage of people that are actually using, you know, repackaged of Avastin right now and then partly why we’re doing this this product.

Firas Rahhal: Yeah, let’s talk about that. Jeff. I know you know, the numbers and I know I’m, I’m a practicing high volume, you know, Retina Physician, I know the numbers in my own practice, in the group I work with and around the country. I have a sense but why don’t you share with us what proportion of people are using Avastin and say, in the component form, of course, currently for wet AMD or the other indications, diabetic macular edema, vein occlusion and then maybe share with us what you think the advantages are now to have an ophthalmic preparation that you will produce once you get finished with your development plan, which we’ll talk about also.

Jeff Evanson: Yeah, so the to cover the market share. This is a well studied topic. I’ve spent the better part of those 10 years looking at this repeatedly for our number of reasons. And what’s really interesting is still today after all this time and after even innovation that’s occurred with whether you call it Eyelea or Bevacizumab, as you know, into the market. What is interesting is the off label use of Bevacizumab still remains at north of 50% of patients treated. And you get a variety of sources to tell you some, you know, different sheer numbers for Eyelea, but it’s generally about 30%, you get about 12, or 14%, Lucentis. And that’s just in a very generalized way, in terms of market research in the US. In Europe, it’s a little different. And so the off label use of Bevacizumab is less than it is in the US the interest is as high as it is in the US to use a lower cost anti-VEGF product, but the restrictions that have been imposed for a variety of reasons have have really reduced that share uptake. And so that’s why we are excited to have it on label version of this product provided in that market, as well as the US just to share some some numbers. You know, the why we’re so excited is that we feel, you know, we’ve committed and we’ve said this publicly about having responsibly priced product, you know, our goal is to provide, as Terry’s mentioned a GMP product that we that the physician community that knows already, but could have an elevated sense of safety, and get the efficacy that they will most often get, but to not worry about anything. And we’ll talk a little bit more about the, you know, product offering that will ultimately have in a vial and in overtime in a syringe. But the but really solving some of those important issues. You know, we’ve talked about in the past some of the activity at the podium about physicians, your colleagues sharing their own experiences with either syringe malfunction, there’s the issue of silicon oil droplets, you know, other particulate type concerns to one underreported area that we are really sharing information on about potency. And when you have the supply chain, when it works as designed and USP is followed, then everything should go to plan. But oftentimes, there’s no quality control against that. So that the potential of getting something that is not the right volume, or that has been compromised due to a number of other factors, you may not get the potency that you want when you’re injecting a patient and, and so we’re really feeling the the need in this program to solve a lot of those those issues. And again, with a commitment of a responsibly priced product.

Firas Rahhal: Yeah, I couldn’t agree more that for some reason, this dosing issue. And we’ve talked about this, you and I, offline, it seems underreported, because of all the things that one can experience the silicone oil bubbles, etc, that you mentioned, the dosing issue seems to be relatively common in my hands, and I am a big user of compounded evason. And these numbers that you read smack pretty clear for me 50%, 30%, 12 to 14%, I’m nothing if not predictable, that sounds almost exactly like my practice. And I’m glad to see I’m following falling in line with the national numbers. And I do think we see this kind of across the board with some demographic differences around different states, which I want to ask you about. But this dosing issue is real, because they give you such a small amount, and if the pharmacy has improperly calculated the dead space of the needle in, it seems also very obvious, but there are many times I’m fairly certain I’m under dosing actually overdosing doesn’t seem to be an issue because we control that the under dosing I don’t think is as rare as one would think. And you wouldn’t really know you might just assume you’re not getting the biologic effects you want and maybe you switch to another drug but maybe you were giving too little of the drug. I’m pretty sure that does occur more often. And maybe it’s impossible to study but I’d love to know what percentage that is. I think it’s not an inconsequential amount.

Terry Dagnon: There’s a great paper in JAMA, a unity paper on that, where they actually asked aid from 10 different compounding facilities, what was in the syringe too and there, the depending on how long people store stuff, and depending on what syringes it could be a real issue. So it’s one of our products offshore, GMP source with established shelf life controlled storage conditions. And once again, we’re very, very excited about our product opportunity.

Firas Rahhal: Me too. Terry, or Jeff actually may be better for this. I don’t know you guys can tell me. Where are you in the development program. Now I’m in the trial. I know we’re doing clinical trials. But as a kind of masked investigator, I don’t know exactly what’s happening with the other centers. How many of how many patients have been recruited? What can you tell us about where you guys are in the trials? And maybe when the retina community could expect you to be presenting this to the FDA and shooting for approval? The product is called Lytenava and correct me if I’m wrong, but we’d love to see it. What’s the timeline? And where are you right now?

Terry Dagnon: Jeff, I’ll start off and hand over. So we’re running three studies. for registration, we had the end of phase two meeting in April of 2018. And that’s well documented, we’ve said publicly that we got by off on our clinical program, so we’ve been executing it. First study was a clinical experience study, a very small study, and we use those data to open our IND in the United States. The signals that we expected to see in that study were definitely there, the same proportions of mean change and visual acuity. And same proportion of three line gainers that we’re seeing in the CAT study. And also in the peer study in our study design, I’ll come to that as a combination, really, of those two different approaches. Our second study is our large phase three study for registration, which is fully enrolled 220 subjects, same design as the first study but larger, so monthly, ONS-5010, or Lytenava, given consistent with Bevacizumab and how it was given in the CAT study against the pure dosing regimen of Lucentis. So three injections up front, followed by quarterly dosing, our primary endpoint is the difference in proportion of three line gainers between the ONS-5010 arm and the pure dosing arm at month 11. Which if you figure out the timing, that’s the absolute trough effect of that last quarterly injection. So FDA bought off on the study design, which we think is quite innovative. We had a choice superiority design, less subjects quicker to get done, less cost for our company quicker and faster to market versus doing a very large non inferiority study, which was what CAT was CAT already showed? and answer that question that look Lucentis, and the Bevacizumab studies in that study were remarkably similar both from a safety and efficacy standpoint. So we chose the expedited regulatory path and save money with the innovative type design. A third study we’re conducting right now is what we call nurse three. It’s a open label safety study, and it’s designed, it’s fully enrolled and enrolled in one month 180 subjects. It rounds up the total we need, we need 300 exposures to file the initial BLA. So this will complete our safety population. And then that study we’re looking at whether MD- DME subjects and also BRVO subjects to the other indications that we’ll be pursuing. So our pivotal trial data will be available near the end of July next year. And we expect to file a BLA in the United States prior to year end. So based on our program, we should have US approval of the BLA in 2022. And we are also in discussions with European Union regulators on a filing strategy and pathway there with the same data that we’ve generated in the United States. We do intend on starting our BRVO program and DME program, which were also agreed upon in our interface to meeting and that we have approved FDA spots for also next year and continuing to develop the clinical development program to see both of those indications as well. Jeff any, did I miss anything there a perfect time for a handoff?

Jeff Evanson: Yeah, I would I think that’s a great overview. The elements I would add is that in on the commercial side of the house, we often think about the window that we consider T minus 24. So you get to describing where you are in the process of launch. So we’re within the window of a two year to launch perspective, which is exciting for us because that’s when we really begin to think about the pre-commercialization activities where we start to really codify all the publication, communication strategy, all the elements around what things we do to prepare for launch. And, you know, we start to we’ve begun already to work with initial work with payers, for example, and really starting to share the point of view that outlook will be on market and to begin some of those conversations. we formulate our go to market strategy. And really why we’re doing what we’re doing and really getting to ultimately what we consider a go global brand book, which would have all the elements of branding the product, and we’ve already named it, you’ve shared that name Lytenava. But there’s a whole host of activities that we commence in these broad categories of commercial to prepare the organization to launch the product upon approval.

Firas Rahhal: I’m glad you brought up Jeff, the meeting with payers and that that aspect of commercialization this is maybe the worst kept secret, which is it that’s the tricky part of often these launches, and particularly for the higher price stuff, you guys are very responsibly pricing. I know. And those numbers aren’t out. And I’m not going to ask you to talk about that. That’s still stuff to be discussed and elaborated upon, but in going out and having those discussions and, and and the context for this is that different states have handled off label Avastin differently. I’m in California, California has been widely open to the use of off label Avastin, for all these indications, and others, you know, neovascular, Glaucoma, even in the early stages, Parafoveal Telangiectasia was an indication it might still be most of us haven’t had great success with that. But the point being, given this different predilection of the states at the state or federal payer level, and of course, all the differences you’ll see within the private payers, how do you approach that? Are you actually on the phone with medical directors of local Medicare providers and BlueCross BlueShield? How do you do that? And what are those conversations like?

Jeff Evanson: Yeah, great question. So I think is a general starting point, this will be as a new BLA, we will have a unique J code for the product. And so it will fall in the category that you’re familiar with, with the other anti-VEGF, just have by bill economics. So the physician practices will be buying the product, storing it as seeking reimbursement through the J code process. So we will follow that, just as the the others have my background in j code products go back more than 20 years, and really, in this direct relationship with physician practices, and what is what is really known to be true. And frankly, while l Alcon certainly has this as a distinctive competence, Medtronic really was the area of helping physicians, you know, in terms of the support from a reimbursement point of view of really understanding what are the reimbursement codes? How do you properly do that, you know, what are those activities? And how do you work with medical directors within the major plans that are in the catchment area of the physician practice? So all the prior auth work supporting that. So that’s kind of the back end upon launch it you’re well familiar with. The pre-launch activities include two different tenants, one’s the national conversation. So national Medicare, you know, when you talk about CMS, in this case, this category is is an important backdrop is the third largest category of reimburse within Medicare Part B, it’s very expensive for Medicare. And then I’ll go to the private the administrators of administrators of Medicare Advantage, so Aetna as United Health BlueCross, BlueShield, etc. So there’s a real interest in having why we are excited, there’s a real interest in controlling those costs, because they can’t keep going up. We all know that that to be true. So with a responsibly priced option, what so we’ll have a national Medicare, definitely strategy and that work will begin in 2021. The local plan coverage is where we’re seeking insight around how do we work together to provide a safe alternative to the marketplace in a way that when you codify your treatments, preferred treatment, algorithms, and coverage that were considered within that. So we want to give enough information and work together to be in really, in all my years of launching Jayco products within ophthalmology, but with outside of ophthalmology, you know, you’re often industry is probably guilty, a lot of times of naming a price and then fighting for the price with payers. We’re taking a different strategy. We want to be collaborative, very early in the process. So in early 2021 and beyond, we will continue those conversations around how do we bring an important tool to the marketplace that is safe, you can you can count on the efficacy and the potency that we talked about at a fair price. And so we were really excited about the conversations we’ve had thus far. And they will will be more in depth in the coming months and quarters.

Firas Rahhal: And you felt the folks on the other side of these calls or conversations, I’m assuming yes have been quite receptive to the idea as of now.

Jeff Evanson: Yes. And I think one of the things that we start to as a commercial pre commercial activity, we want to have a sense, we do a lot of de identified blinded research with payers and decision makers. And we try to expose them to target product profiles. And ultimately, we share that first. And then we follow with different levels of price, different levels of consideration, including their own step, edit constructs, and how an important option like this would play into that. So we have a good sense beginning, what range of price are supported, and the way the payers seem to, you know, there really is, you know, careful about the cost of therapies and what they want to know, how does this fit within their book of business that they’re supporting. And there’s something called willingness to pay. So we get an impression early on about different price levels around where they feel up to this price point per vial per treatment, they would have no restrictions, and then after you go above a certain price point, then they would say, Well, you’d have to have some evidence that works better, or it works differently, or what have you. So we have a good start, we have a great foundation for that conversation that we’re going to build upon. But I can just tell you, with our commitment of going to market it in the price range, we anticipate, I think payers are going to be really excited about where we’re coming in.

Firas Rahhal: Yeah, I do, too. I, it seems to me, that’s gonna be even without your charming, easy to talk to miss. That’s going to be a fairly easy probably dialogue to have with payers. A proven product that’s already to be sure 50% of the marketplace that’s now safer, and perhaps more predictable, and thus better. Kind of a no brainer and lower costs than some of the other products a bit of a no brainer for the payers, I think, where do you see this product fitting into the market? There’s already a 50% market share, as we discussed for off label Avastin. Does this replace all of it, most of it, some of it? Have you guys thought about where this fits in? And what percentage of the market is realistic?

Jeff Evanson: What I would say as a general point, and Terry, please add your thoughts to this is that we are our strategy is to add this as a important option in the marketplace, we are very confident that with doing the things that we intend to do that we can be a first line therapy and option for the retina community. And we want them to be compelled to use this. I think the, and the payers, by the way, one call out to the payers is that a lot of our work next year, especially through the traditional, you know, medical science liaisons and other ways of educating the payers, we have to spend the time to make sure they understand the trade offs of you know, things that can go wrong and what happens when they do. And we just again want to compel people to use this and to include it in treatment algorithms. In terms of how many, we’ve got a range of scenarios that I can just say that when we did the proper market research that included payers, qualitative for the payers, we did qualitative and quantitative without going into all those details. Qualitative is generally an in depth discussion in interview where you get a lot of insights quantitative is getting to actually allocating patient share to a product that would have a profile that you share with him. We were very excited with the results. We were actually quite surprised that they were we had a lot of different scenarios. And the the sheer preference that came back actually exceeded everything that we had studied thus far. So we are very encouraged. And it really is that commitment, though. But safety, potency assurance. And then when you add the price element to that I think people are really excited.

Firas Rahhal: Terry, you’ve been around. Thank you. I totally agree. And that’s very exciting to hear that you’re getting that kind of feedback. Terry, you’ve been around the eye space so much and for a long time. Quick adoption. I mean, is there any reason there wouldn’t be a quick adoption? And for either of you? What barriers might there be that I haven’t thought about? What have you thought about as potential barriers to adoption or market cheerier for you.

Terry Dagnon: So in my career, one thing I’ve learned, and I think it’s all of us on this call would say the same thing and feel the same way as we started with the patient. I don’t think any of us don’t have a family member that hasn’t been touched, and has been receiving anti-VEGF injections. So providing a responsibly priced product, you know, for people, you know, on the back nine a life that have these age related diseases. It starts there working with the physician community, making sure that this fits in and seeking the advice of keeping and leaders such as yourself, and your colleagues, making sure it’s a win win for the patients, for the physicians, for the payers. That’s the kind of product that is so exciting to work on. And since the start, we’ve taken that, that approach with this opportunity and realize it is truly one of those opportunities where we can create Win, win win. So you’re right, we continue to look at the work that needs to be done. And it’s really about operational execution at this point, we have a good plan, we’ve got a bunch of great partners that we’re working with. And we’re executing that plan. So we’re super excited about some of the milestones we talked about coming up next year. And certainly the following year and getting into the other indications. But the I’ll go back to everybody knows the peer study and the peer results that CAT study the CAT results. And we’re not having to convince anybody that this is at a high probability of success. It’s really about getting it done. Getting it filed and getting it out there to benefit patients, physicians, and and frankly, payers, that win win win.

Firas Rahhal: Jeff, you have any additional thoughts on any

Jeff Evanson: Yeah.

Firas Rahhal: Any barriers that you might think I it seems pretty straightforward. I agree with Terry, what are your thoughts?

Jeff Evanson: Well, what I would say in any going back to the comment that I made about neurosurgery and retina, really having a lot of parallels. I love the retina community, again, such an innovative collaborative community. And I think people have learned some hard lessons about when things don’t go right, what happens? right? And fortunately, I’ve been able to be the benefactor of working for a company like Alcon, that’s just has an amazing reputation. They’ve earned it over so many years. And with that collaboration, I think others have taken a different strategy where I think they’ve tried to export their thoughts without really a lot of involvement for retina. So the other thing that we didn’t talk about, is the collaboration that we intend to have Terry referenced the KOL, you know, influence in education, we really want to partner with the retina community, they are it you would ask about the question around how this strategy was enabled, and Terry referred to the the patent expiration elements, you know, and in the clinical strategy, you know, they’re really important three legged stool is the commitment within the CAT study, and what it did for the foundation. And that was, it’s such a strong, active community, we can’t do that without the collaboration with the community. So the way I translate that as the important discussions beyond payers, is even within the society, leadership’s and making sure that we’re interacting and supporting key initiatives that really help further educate, and support the education curriculum, etc. So we, you know, we will do all of that, in partnership in all the right ways. With retina, we really want to be partners with the retina community and all of this.

Firas Rahhal: I think that’s really smart. Obviously, I find it It’s gratifying to hear I’m a retina doctor myself, but honestly, as objectively as I can say it. It’s an innovative community and retina doctors are early adopters of technology. This is widely believed in industry and in our, our clinical specialty. I won’t, I won’t say risk takers, but definitely there’s an innovative mindset and new products are accepted and quickly. And it’s because we get such immediate feedback from the patients, you know, you put a drug in the eye, and it works. And the guy comes back a month later, and he’s better. And he tells you, it’s better. That kind of feedback isn’t there and every medical specialty, we’re fortunate to have that quick return on investment, so to speak of our time and our efforts that the patient sees better. And they tell you that and so yeah, reaching out, I think you’re smart to do so. And you reach out and get connected with the societies who then have their people all become aware of the product and where it might be useful. They’ll have their own thoughts and they’ll share them with you and that can help you as well. I think that’s really smart. What about like institutional medicine? Will you be reaching out to places like the VA or Kaiser Permanente, these places that are big buyers, but also control a lot of patients and obviously cost conscious?

Jeff Evanson: Yeah, I think this you know, in some ways a product like we’ve talked about in our ONS-5010- Lytenava will be a perfect blend of the needs that they have more than ever containing costs, but assuring safety right and efficacy for the patient, you know that the most ineffective, a cost ineffective way of treating patients is something where you have to rebuy potency are a safety concern, when we can solve for that, and so that that I think is going to be definitely within the strategies for 20, early 2021 of having those conversations with them. bigger systems because we feel there’s a lot to offer, again, assuring patient efficacy, safety, but doing it in a cost effective, responsible way.

Firas Rahhal: And I want to pivot for just one final concept here. It’s premature for this, but I’ll throw it out there. And you guys can give me your thoughts. It’s sort of on pipeline concepts. I’m not even saying pipeline products. Although if there’s something you wanted to discuss, I’m happy to hear it. Everyone in this space, both on the industry side and on the clinical side is interested in making these drugs more durable, you know, longer acting, longer functionality. Any thoughts down the road on your product? Are you thinking about things that will increase the durability of the effect of this drug? versus the current say monthly or six week dosing?

Terry Dagnon: Definitely used to start on that one.

Firas Rahhal: You don’t have to specific I just yeah, I’m speaking down the road here.

Jeff Evanson: Yeah, I would say you know, for for Outlook, right. Now, as you can imagine, with a small organization doing what we’re doing, there’s a lot on our plate, we’re 100% focused on our own s 5010. And advancing in the clinic, not only with wet AMD, but DME and BRVO as Terry was sharing. But I would also say that, you know, our intentions would be to explore and build right over time. So we are actively thinking and, and nothing to share no specifics to share. But, you know, our backgrounds that Terry and I collectively, we actually first met and some of our first time together, traveling internationally and otherwise was around, you know, the concept of of innovative ideas that go beyond what you’re currently working on. So I would just say, in a general sense, our interests are there. And you know, we just need to make sure we’ve got 5010 on its way. And, and I think over time, you might be hearing more more from us on that front. Terry, I do on that response, anything to add?

Terry Dagnon: Just that was perfect. And but I would add, it came up early in the discussion. There is a lot of effort right now going on to follow our initial approval with the vial with a prefilled syringe. And we’ve got a great partnership with a world class organization, some of the smartest people about syringes, and it’s not a glass syringe, it’s a cyclic olefin polymer syringe. So we’re very excited about it. The work is ongoing. And it’s a parallel track, and we’ll be filing that as as opposed to approval supplement. But I think that’s one that we’ve talked about publicly so we can talk about that freely. But I think it’s one of the back to Jeff’s comment about how excited he is not just about working drugs, but drug delivery, too. So a prefilled designed to be in Ophthalmic syringe, cyclic olefin polymer syringe is right in the sweet spot of innovative makes the job easier for everybody on the healthcare side. As you know, prefilled syringes are available in some other products. But we fully intend on having one quick as quick as we can. And it’s currently on a parallel path with our BLA filing to be a post approval supplement. And we’re excited about that, that so that’s one we can talk about.

Firas Rahhal: I can tell you having done 10s of 1000s of injections myself, of course prefilled syringe really, I didn’t know this at the time we first talked about it, that it would matter. It matters, it’s really a nice feature for the clinician, and more importantly, the clinician staff, that who are outside here, you know, preparing for tomorrow. It’s a lot of work to do all this when you’re when you’re pushing dozens of injections a day. And the prefilled syringe is a brilliant idea. I’m glad others have done it. And I’m glad you’re going to do it and I look forward to seeing your product and then seeing it in a syringe. I think that does serve a lot of advantage. I’d like to close by saying to both of you that this is an amazingly important project I. You should be proud of yourselves for for carrying it. This will obviously, it’s an understatement to say this will impact millions of people this will impact 10s of millions of people, if not more, this will be a worldwide important product. And the cost effectiveness, you know speaks for itself and how valuable that is to not just the US but the entire world. I want to thank you for coming on and give you a chance if you have any final thoughts please feel free.

Terry Dagnon: I would just say thanks for having us and allowing us to share our story. Obviously, the story continues. And we’d love any chance that you want or need an update as we move through our development cycle milestones and launch. We’re very happy to tell the story and continue to update the community that’s very important to us.

Firas Rahhal: Thank you, Jeff, any final thoughts for you?

Jeff Evanson: I would just echo what Terry said. And just we really, as I said, have stated several times just really appreciate the collaboration, the openness, the willingness for the retina community to embrace and support what we’re doing. And we’re excited to advance and create this important option in the armamentarium.

Firas Rahhal: Thank you. Thank you, Terry and Jeff, both of you, I’m proud to say have become friends. I enjoy working with you. I appreciate you taking an hour or more out of your day to join me today. I’m sure the viewers have benefited. This is a great product, and all of us in the retina community to patients. Thank you and look forward to it. Thanks for coming on.

Terry Dagnon: Thank you very much.

Jeff Evanson: Thank you can join it.

Firas Rahhal: Right. Nice. Nice job. Gentlemen. That was a great conversation. He got Terry and Jeff. Really good, very informative to you. And yeah.

Jeff Evanson: I know you’re pretty good at innovating, and also as a retina surgeon, but you might have a third career. If you ever need one. I’m just telling you, you do an amazing job moderating.

Firas Rahhal: Thanks a lot. Craig pays me very well. By the way, Craig. I wasn’t kidding. In my text. Those are two very special wines that are very popular at the Rahal household. Craig lips sent me two lovely bottles of wine for holiday. And I wanted to thank him face to face now. I texted him really perfect. You hit a home run. Great. I’m glad thank you for that. I’ll keep it coming. That’s my pay. Right? Exactly. Lovely. bottles of wine. And by the way, it’s better than most HMOs famy. I’m pretty thrilled with

Terry Dagnon: Bitcoin. Exactly.

Firas Rahhal: Well, guys, I hope everything good. Yeah, excellent. I hope as things do progress, you know, we’ll have you back on here. And hopefully, presenting whether virtually or in the future at a live program as well. But we we do have a retina innovation showcase. For I don’t know the exact date, but it will be sometime, you know, in we have a forward schedule. So, yeah, we’ll just we’ll keep tabs on on you guys. And hopefully we’ll have you back to share the story further. Yeah, I think Terry and Jeff, one of those revenue, innovation showcases what for whatever timing works for you might be perfect chance to present, you know, whatever, it’s 5-10 minutes, you know, let some data presentations and so forth, especially some of this clinical trial data is coming to light. It’s a nice feature of iOS. And for the moment, we’re doing those electronically as well. But in person eventually, hopefully, we’ll get back to soon enough. Yeah, sounds great. Yeah, and we’re, we’re, we’ve been annual subscribers to OIS, you know, you by the year pass and, you know, go thoroughly enjoy the audience. We’ve been waiting, you know, because it’s but now’s our time to tell our story.

Terry Dagnon: You know, hey, we’re gonna do this is not much on a podium. But we’re at that spot now, where, as Jeff said, we’re inside the 24th. And less than that, and we’re actively out, it’s time to, to really tell our story. And I think a lot of people know about it, and some were apprehensive. But now people realize that we’re going to do this, right? We’re going to partner with the retina community. And there’s no way that that won’t happen. So we’re looking for Win, win win. I agree. And I think that I want to reiterate that to the two of you. It’s not just that it’s your time it is and you should start doing whatever you need to do and I know you haven’t. And I’m part of that.

Firas Rahhal: I think for any of the naysayers of the doubting Thomases, for me personally, the best thing you could do is put guys like you up in front of people, the sincerity and the patient centricity comes clearly through, you’re just nice guys trying to do the right thing. That’s an important message. It sounds ridiculous and silly. But as a clinician, that means a lot I think to know that the company is people like you like there’s a there are persons behind this, who care about patients and the doctors.

Jeff Evanson: Thank you for saying that. That’s appreciated. And that, yeah, that the turnover thing for both Terry and I and why we’re doing it exactly.

Firas Rahhal: You get up in front of people or get to meetings and people get to meet you and know you, it’ll be obvious and, and that carries a lot of weight that nobody’s up to anything here, this is a good product to serve patients in a good way. And, and, and cutting costs is good. You know, there’s no one can look at that wrongly other than maybe some companies who feel like they’re afraid of losing market share, that’s their problem.

Terry Dagnon: Well, the buckets not getting bigger. And in order to have new things, you got to you got to take some make some space in the bucket, right? And instead of them squeezing you guys for your surgical fees, we’re providing more money in the bucket by doing this, you know, and

Firas Rahhal: that’s important and and like making, that it’s win win win. Yeah, that’s a good selling point. And the doctors who aren’t on the podium, held the time for Eylea Lucentis. And by the way, great products, I get great products that I use every day in volume, but but behind the scenes that talk about doctors losing their surgical fees, and everything else, due to the proportion of Medicare Part B, going to those two drugs. That’s a widely held belief and conversation, be not at the podium, but in the back of the auditorium. And I’ve been part of millions of those conversations. And I think it’s a good message I you know, you it’s not the main point of what you’re trying to do here. But if you do connect with the community, which you are in which you will, and you get to have those conversations, semi privately. That’s a that’s worth noting. There’s there’s a lot of good in that doctors care about that and, and they should.

Jeff Evanson: And well said

Firas Rahhal: thank you. Thank you all. Do we can we free these gentlemen up for their evenings with their families now? And yourself?

Terry Dagnon: Jeff son has a birthday tonight. Oh, the only stopping him from opening presents and having cake is us. Oh,

Firas Rahhal: I should let you go on.

Terry Dagnon: is turning.

Jeff Evanson: Turning issue. Happy birthday. How old is there? Yeah, he’s turning eight. He was our bonus guy. You know, we’re I got an art card. I think we had a kid or something out. And the good news is it’s like a birthday every day for him. He and Terry has met him he’s chock full of personality. And yeah, he’s a good kid. So congrats.

Terry Dagnon: On field passes, it was a great day. And he goes, Hey, Terry, puts his fist on goes I’m gonna bounce.

Jeff Evanson: Education visa via YouTube right there. Right. teaches the kids. Great. Well, on that note, let’s bounce.

Firas Rahhal: Yeah, thanks, Greg. Thanks. All right. Have a good night. Happy Holidays. Please keep your eye on the holidays. Happy holidays.