Here’s What’s New in Drug Delivery

Click here to watch the video version of this podcast.

A new generation of drug-delivery technology is emerging, with new refillable, absorbable, and dissolvable vehicles making their way through clinical trials. Large pharmaceutical companies, biotech firms, and device start-ups alike are all developing innovative alternatives to eye drops and intravitreal injections.

 

These platforms are important for improving compliance and patient outcomes. The ability to extend treatment duration also alleviates some of the patient and physician burden that comes with regular injections.

 

To explore the latest advances in the ocular drug-delivery space and their potential impact on patients and practitioners, we brought together at the OIS Drug-Delivery Innovation Showcase an A-Team of medical, venture capital, and industry experts.

 

Listen to this podcast to hear our panel discuss:

• If longer-lasting therapies, injectables, and resorbables represent a new bar for existing technologies.

• What’s in development at Bausch + Lomb, Aerie Pharmaceuticals, and Allergan/AbbVie.

• How these new delivery systems will change the dynamics in the clinic.
• What companies in the early stage of commercialization should keep in mind to ensure success.

Click “play” to listen.

 

Transcript

 

Sharon Bakalash: Many thanks for all the presenters, you’ve done a fabulous job. For the panel discussion, we are joined by representatives from multiple aspects of our industry, strategic pharma companies, midsize companies, venture capitalists, and a physician representation. So I will let the panel members introduce themselves. I suggest that we start clockwise. So Rob, feel free to take it away. 

 

Rob Rothman: Thanks, Sharon. Hopefully the OIS audience is relatively familiar with me since it appears that I can’t seem to keep my mouth shut any longer for OIS. But my name is Rob Rothman. I am a Glaucoma Specialist by training. I practice clinically about 50 to 60% of my time is involved in the clinical management of glaucoma patients. And the rest of my time I spend running InFocus Capital Partners, which is an early-stage ophthalmology investor, we typically invest in venture and seed stages. Our first fund is now closed, and we have 13 portfolio assets. And we are currently nurturing those assets and contemplating the launch of our second fund. 

 

Sharon Bakalash: Thank you, Hari. 

 

Hari Stavrinadis: Hello, I’m Hari Stavrinadis from Allergan, I am the Executive Director of Durysta Marketing located out here in Irvine, California. 

 

Sharon Bakalash: Thank you, I think next one is Nancy. 

 

Nancy Lurker: Hi, Nancy Lurker, I’m the CEO of EyePoint Pharmaceuticals. We are a publicly traded company that is in the drug delivery of Ophthalmology agents primarily retina, for serious eye diseases. 

 

Sharon Bakalash: And Chuck I think that’s your turn based on the algorithm here. 

 

Chuck Hess: Hi, everyone. I’m Chuck Hess, Vice President and General Manager, for Bausch + Lomb, US Surgical Business. Great to be here with the group and looking forward to an active discussion. 

 

Sharon Bakalash: And Casey, last but not least. 

 

Casey Kopczynski: Casey Kopczynski, Chief Scientific Officer of Aerie Pharmaceuticals, also a Co-founder of the company, I helped David Epstein spin the company out of Duke University back in 2005. 

 

Sharon Bakalash: Well, thank you very much, everybody for taking the time to join in this discussion. For this discussion, I divided the topics into four parts, so that we can touch upon this year’s new developments in the drug delivery segment of the market. So the first topic is a new generation of drug delivery technologies. As we all know, a new generation is emerging refillable, dissolvable, absorbable new entrants to the market are upcoming this year representing those technologies just like Genentech’s, Susvimo, and which is tackling a novel pathway of delivery and B+L’s, Xipere with Suprachoroidal injection. With that said, I’m really interested to know, Rob, from your perspective as a physician, what would those new drug delivery systems create in the clinic? Would there be new dynamics for that? Will it change anything for you? 

 

Rob Rothman: Yeah, you know, so obviously, it’s a great question. I think the whole focus of this whole discussion is on you know how some of these newer drug delivery technologies will change the way ophthalmologists practice it from the clinical perspective. You know, clearly, I’ll be selfish here for a minute and focus on glaucoma. It’s a fairly well-established problem that compliance with medication usage not only leads to poorly controlled glaucoma and adverse outcomes, but it’s also related to every other aspect of progression disease when we treat with medication. So, you know, I think drug delivery for glaucoma, for example, is incredibly important in terms of improving outcomes for patients. Certainly, you know, we’ve gotten our first taste of viable drug delivery from Allegan. And Durysta, which I’m sure Hari will go into a little bit more later on. But the ability to control intraocular pressure without having patients take eyedrops is sort of a holy grail, and if we can do it in a non-surgical fashion, you know, and avoid some of the morbidities associated with invasive interocular surgery, then we are certainly you know, change the way patients are treated. My understanding and at least having patients in you know, seeing my retina colleagues every four to six weeks for injections, certainly newer therapies to extend treatment duration of you know, current therapies for wet-AMD and diabetic retinopathy, you know, certainly going to make their lives better and hopefully improve outcomes as well. And not just from the perspective of patient convenience, but from, you know, for the ability for these patients to do better over time, improve quality of life and hopefully improve vision. I think the biggest challenge and one that we hopefully we’ll address today is how do we monitor these patients when they’re out of our offices? So we’re going to be giving patients these medical therapies, in a slightly invasive but longer acting fashion? And what are we going to do to make sure that these therapies are both maintaining their efficacy? And, you know, doing what they’re supposed to do over time? And I think that’s a question that has to be answered by this group, because it’s great if we can say to a patient, here’s something that’s going to last for six months or nine months or a year. But how do we know that we’re actually taking care of those patients and not just sending them off into the wilderness? So I think the dynamic in the clinic is sort of you have to be sort of fleshed out. But there’s no question that extending treatment duration is going to be beneficial. And I think that hand in hand with that will be the development of technologies to allow us to monitor our patients better while they’re not having to come into the office. 

 

Sharon Bakalash: And in that respect, and again, the question is for all of you, but I feel maybe, Chuck, you, you can shed a little bit more light on that. Would the dynamics between outpatient care, and maybe surgical or O.R. dependent administration change? Would that dynamic? You know, change or, and affect anything? In your day-to-day life? 

 

Chuck Hess: Yeah, I think this is a really great question. And, you know, I think this is really the challenge that we all face, in each of our businesses is really, how do we maximize the opportunity to deliver these treatments and do so in an environment that is conducive to the patients actually participating in the process, and I think, you know, the surgical implantation of devices, I think, you know, the opportunities to provide longer duration of treatments in the office, I think are all things that we all are looking at. And I think from our perspective, you know, just thinking about, you know, the latest technology that we’re excited to bring to the market with Xipere, you know, we’re really using and leveraging the suprachoroidal spaces. It’s never been done before, in this modality. And I think it’s really exciting for us to really look at things that we can do not so much in the O.R. because let’s face it, there’s not a lot of O.R.s to allow us to treat the volume of patients that we need to globally. And I think that’s really the opportunity that we all ought to be thinking about as we’re traversing this whole space of ensuring compliance, ensuring that we have patients that are adhering to our treatment regimens, no matter what exists, if it’s a six month duration, or if it’s a, you know, an annual administration of a drug or what have you, I think we really need to look at how do we bring the technology to the patient, and do that in the clinic, wherever that might be? Maybe it isn’t no harm, but maybe it’s in the office. And I think that’s where we as a as an industry need to really look at, how do we do that? And I think, Rob, your comments are spot on. It’s really, once these patients leave, how do we make sure that they’re coming back and accepting the treatments that are going to save their vision that are going to keep their pressures low, that are going to treat their uveitis? I think those are the things that we really need to be thinking about as industry is how do we bring the patient back in for the normal routine care, whether it be, you know, repeated injections or longer periods? So those are some of the things that we’re thinking about. 

 

Sharon Bakalash: I think these are all valid questions. Nancy, I want to bring it back to, you know, to EyePoint where, you know, you have had the track record with drug delivery modalities in the market. You have the perspective of time on this, considering that, you know, this dynamics in the market in the refillable, dissolvable, absorbable the next gen type of thing. Do you do these represent a new bar for existing technologies? 

 

Nancy Lurker: Well, first, absolutely they do. And I think it’s going to require a paradigm shift in how the community physicians and patients think about treating these diseases. I agree completely with what Rob and Chuck have said. Because we have, as an example, we’ve got you take on the market, you take us for cluster segment uveitis it’s once every three years, that’s a long time. So how do you make sure these patients keep coming back in, there are ways to do that, but it takes time. Second of all, when you look at, let’s just call most of these treatments I think are aiming for six months, right? Susvimo, is that six months, we’ve got a drug going into phase two for six months. So and there’s others four-to-six-month time periods. For these retinal eye diseases. Glaucoma, I think there’s some in development as well. And what you have to do is, in some cases, you need to think about that these patients still need to come in, maybe not once every month, but they still need to come in probably at a minimum once every three months, even if you can get them extended out to a longer period of time. Certainly, we’ve seen this with you take for uveitis, so they still need to come in. But what needs to change is not every time they’re going to need to have a retreatment, it may mean that they are being monitored, and then the doctor just continues to see them until he or she feels that they need to get retreated. That’s the paradigm shift that’s going to occur. And in some cases too you’re going to be looking at what I’ll call semi-combination therapy, you might have the background therapy that’s there at while you may need an occasional booster to keep them under control. So that’s what’s going to be the change and then realizing that just because let’s just take retina, if you get a little bit of extra fluid in a wedding and D patient doesn’t necessarily mean that a treat them right away, because with the current therapies, they start to get fluid back treatment is the current anti-VEGF are gone. So you re inject now, when you’ve got these other treatments that are there in the background, you may not need to automatically re inject. Now it is okay, wait a minute, let me wait a couple months see if that fluid maintains and grows or does it dissipate again. We’re certainly seeing this in our Phase 1 data. There have been some other examples. I think that Genentech saw this in their Phase 3, you might get a little bit of recurrent flow, but then it fades away. So there’s a paradigm shift that has to occur. That’s going to take some education, frankly, I think more clinical work to really play out what does this all mean? 

 

Sharon Bakalash: And I think we’re in complete agreement with regards to retina but what happens in glaucoma? Hari, would you mind? You know, considering Durysta, enriching us with, maybe the nuances between retina and glaucoma in that manner, our glaucoma patients less sensitive to that, or they’re more sensitive to that? 

 

Hari Stavrinadis: Yeah, I think there’s a lot of similarities, right? You’re talking about two chronic diseases or disease states. They’re really just required care over time. So when you talk about sensitivity, I just want to make sure I’m understanding you Sharon, what is the sensitivity you’re referring to? 

 

Sharon Bakalash: With regards to the changing dynamics between patients follow up and patient’s care? 

 

Hari Stavrinadis: Sure, sure. So in regard to patient follow up, it’s quite similar to what physicians have always done, right. When you think about the types of relationships that doctors who treat chronic diseases, whether they be glaucoma, or random diseases, they have a special relationship with those patients. And they’re used to seeing them regularly. And, you know, Rob talked about some of the challenges that these patients face. And you know, Durysta, you know, as the first entrant in the market, when we think about IOP, lowering, but it’s an opportunity to get that patient sustaining IOP, lowering over time, the monitoring, the patient shouldn’t really look too much different. But the reality is there’s an opportunity to treat these patients in a way that we’ve never had before. So this is really the first chapter in IOP lowering and sustained release. And we’ll see how that continues to evolve. 

 

Sharon Bakalash: Yes, absolutely. And so my next question is actually directed to all of you. What type of you know, maybe Rob, Casey, Chuck, Hari, if we’re talking about drug delivery, or new drug delivery technologies, there has been no major change, I think, with Xipere and with the Susvimo, but are we looking at additional drug delivery technologies to invest in? Is this a one and done for you? How do you leverage a technology of our platform technology, like the print technology to create more product or is this something that you’re right now sitting on your current assets and letting them play out? What’s the strategic direction for each of you? And I think you know; I will let you interact with one another in that as well. 

 

Casey Kopczynski: I’m happy to start. Yeah, I can certainly speak with respect to Aerie and our print technology, we do believe it’s, you know, it’s something that has a lot of potential moving forward to treat multiple different diseases. And we think the focus on delivering small molecules to the back of the eye, as opposed to the biologics that have typically been developed and are currently on the market really has attractiveness, because you can address disease targets that are known to be involved in the disease process, that are simply not accessible to do biologics, intracellular proteins, for example, you do typically cannot get a biologic inside the cell. And going back to the Aerie and glaucoma for a second, I mean, we do bring sort of glaucoma focus to the retina in terms of looking at the diseases in the back of the eye and understanding that they’re at least as complicated as you know, disease at the tricolor meshwork that causes elevated IOP. So can we really expect wet AMD to be adequately served by you know, primarily one drug class, anti-VEGF drug class, I think that’s unlikely to be the case, even if we can improve upon the efficacy of anti-VEGF, you know, there’s still that underlying atrophy that’s likely to continue over time. So we may simply be sort of putting off the time that it takes for geographic atrophy, for example, to develop, but it will eventually come up. And so it’s easy to imagine, you know, five to 10 years from now, Retina patients needing you know, two or three different treatments, you know, sometimes in combination to adequately control their disease as much as we do with elevated IOP and glaucoma. And that’s where I think the having access, the ability to address multiple different types of targets becomes important for combining different modalities and have the ability to have more sustained delivery of the drug, less frequent injections, because of a patient now has to be on two or three different individual injections. Certainly you want those individual injections to be, you know, relatively infrequent once every six months, maybe even once a year would be preferable if you have two or three different products that are being injected into the same patient. 

 

Sharon Bakalash: Chuck, what about B+L? Are you looking at other things, or are you sitting on Xipere now? 

 

Chuck Hess: No we’re not sitting, we’re not sitting on our assets as you mentioned before, I think what we are doing now is we’re looking at opportunities to explore different types of treatment modalities. And, you know, I think everyone’s probably aware of our work that we’re doing currently with Eyenovia, which I think is very exciting, you know, addressing childhood myopia with a technology that will allow us to get the drug to, to the patient with minimal discomfort and with, and I think those are some of the things that I think are exciting about it’s not just necessarily long duration of the product, but also a more efficacious delivery of the drug. And I think those are areas that we’re also excited about as well. I think Casey mentioned a little bit about small molecule, we introduced our Lomax small molecule product as well. And we’re finding that, you know, we’re able to achieve to twice the penetration of the drug. And I think those are some of the things that we all ought to be, you know, really thinking, you know, more specifically about is, is the types of delivery of these products, I think, are really the opportunity that we have to ensure the efficacy of our treatments. 

 

Hari Stavrinadis: Sharon, I’ll jump in here you had asked is this a one and done and I could say for Allergan, that is an emphatic no. So we are committed to this space, we are committed to drug delivery. And when you think about even Durysta’s journey, this is a product that was developed within the four walls of Allergan, it took 15 years to get it to market. So we’re just getting started. So it’s exciting and is when we think about, you know, the future of drug delivery, I think, you know, there could be a day where a physician could reach into their cabinet or to their refrigerator and pull out one of any different type of molecules that can be injected in the eye to help patients with chronic diseases. So, you know, like anything else, you know, you always try to make improvements and when you think about the future of drug delivery, it’s how do we make it better, you know, when you think about products that they’re QID want to make a TID? Once there TID we want to come be DID, you know, there’s always things that can be done in this space. So it’s really just about advancing the platform from here on. 

 

Sharon Bakalash: Well, thank you very much. I think I think we’re up to the second point of our discussion. And I think this last second message that we discussed leads us directly to that, because we all know that, you know, the lion’s share of the drug delivery scene is in the retina space. Second only to and, you know, glaucoma and inflammation are secondary to that, as far as the market share of that, but we recently are seeing new areas that are being looked at, such as the childhood myopia, such as allergy and so forth. And I think in that respect, we’re looking forward to hearing from you Rob. What unmet needs exist, that needs to be conquered by drug delivery. What trends do you see where your focusing either on smaller markets or even different markets that are not necessarily smaller? From a physician’s perspective? From a clinician? 

 

Rob Rothman: Yeah, I think I’m going to give you both the physician and the investor perspective. You know, I think they were slightly different hats when I view these things, it’s hard to separate them sometimes. But, you know, first of all, there are drug delivery technologies out there, you know, we have drone delivery, right. So we have some of the representatives from those companies on the phone, right? We have Dexycu which is technically a drug delivery, right, we’re delivering steroid long term in the AI, we have Durysta, which is delivering, you know, bimatoprost, you know, long term into the eye. We have Punctal plug delivery systems, from companies like Oculus therapeutics, we have, you know, a lot of technologies that already exist to try and deliver drugs differently. And I think the point of that is that there is going to be a continued and prolonged attempt to try and make the delivery of pharmaceutical to the eye for patients with ocular disease more efficacious and easier. That’s the bottom line, this has to be a continued process, because in every disease state in ophthalmology compliance is the biggest problem. And, you know, as much as I love my patients, that horrible, right, it’s just horrible, taking drugs. And, you know, I again, not to sort of beat-up ophthalmology and in glaucoma in general, but, you know, with the exception of, rho kinase inhibition in the form of rho pasa, you know, we’re pretty much using drugs that we’ve had for 20-30 years and still making patients take them two or three times a day. It’s very, it’s sort of non-sensical. When you think about how difficult it is for patients to do that. So I think regardless of the ophthalmic disease state, we’re going to be using pharmaceuticals to treat these diseases, because there are great pharmaceuticals and the advances in pharmaceutical technology are incredible. From and I can say that from both the clinical and industrial perspective. The question is that if we can get them or get patients to use them correctly, they’re not going to work. Right. And that’s the fundamental problem here. And that’s one of the biggest reasons that patients have surgery in my clinic is because medications aren’t working and not necessarily because they’re not working. It’s just not being used. And I think it’s the same thing with any topical delivery. It’s sort of comical when you think about you know, glaucoma doctors are trying to find ways to get patients off drops, Retina doctors trying to find patients ways to get patients on drops, and to try to think about the best way to treat these diseases. But ultimately, we need to take the patient out of the equation, right, they have to be given an opportunity to have their disease treated in a way that’s simple using an effect that you know, whether it is allergy or myopia, or inflammation or glaucoma, or wet-AMD, dry-AMD diabetic retinopathy, whatever disease you’re talking about, we’re going to be using drugs and we need to figure out better ways to get them in the eye, though, the market is wide open. And, you know, from the investor perspective, we have seen so many promising delivery technologies that are getting close to maybe being ready for, you know, investment level from, you know, venture capital funds such as ours. We have one drug delivery asset in our portfolio, that’s doing very well. But the reality is that all of these technologies at the present are focused on delivering therapy. And for those of you who were at AAO and listened to some of the presentations, the FDA is getting a little annoyed at us, you know, continuing to look for therapies and not cures. So, you know, we’ve got to sort of figure out how to balance the improved efficacy with continued FDA help in getting these technologies to market. Ultimately, we have to think about longer term In ways of actually fixing disease rather than just treating it. So all of these things are, are out there and all of them have to be tackled. And there is definitely an incremental step, improvement in duration of efficacy and our ability to get patients to take these drops, that has to continue. And it has to continue, ultimately, and get until we get to the point where, for the Holy Grail perspective, we give patients one thing one time, and it treats them or cures them. And, you know, that’s where we have to end up one day. 

 

Sharon Bakalash: Fair enough. Fair enough. I’m going to ask Nancy. Nancy, from your perspective. And again, this is this is probably a question to all of you. So I’m going to let Nancy start and then feel free to chime in. There are limiting factors for adoption of drug delivery technologies. From your experience. What minds should we avoid? What you know, what barriers to entry with regards to adoption exists for drug delivery? And what do you think we should do about those? 

 

Nancy Lurker: Well, let me if you don’t mind me, also, just I’m going to add on to what Rob is saying, because I think one thing, he thought he needs to understand, I think a lot of people do, certainly in the ophthalmology community, but even beyond that, maybe for investors who may not be completely conversant in this space, we’ve got a tsunami of patients that are going to crash into the available number of providers. And it’s a real problem. And I think that’s why there’s such a high need for this because you literally cannot have these patients coming in every month, every other month, whatever it is today, to get this chronic treatment on such a short time period. It’s not sustainable. I think FDA certainly recognizes that we certainly can see that. And some of our interactions with them. Everybody is from CMS to FDA, to the providers want to see this extended treatment period, not only for compliance, but just because to manage it in the system. So as to the paradigm that needs to change. Look, you know, I’ve worked in the industry for many, many years, and I’ve been in multiple therapeutic areas. And so there’s some basic paradigms that are consistent across therapeutic areas, one, physicians tend to be inherently conservative. And I would say for good reason, safety first, right? First and foremost, you’ve got to keep the patient safe. So doctors want to take time to see that these new treatment paradigms work. So that’s number one. So but if you add that, in that you’ve got to have additional data, that’s why I keep stressing that. I think it’s up to us manufacturers to make sure that we are providing not only the basic phase three studies, but additional ongoing phase four studies to get the community comfortable with how you use these different treatments. I give you one case, in our case, multiple injections, if you’re going to do a once every in our case, six-month implant, what does it look like? What you add the second and third implant and these dissolve over time? But nevertheless, what does that look like? What does it look like when you have to give an occasional booster, all that you’re going to need the data to get the community comfortable and used to using these new treatments? So I think that’s first and foremost, making sure the data is there to support the use, number two, educating and then number three, we have to get the payers comfortable as well. That’s a heavy lift. And I think all of us combined can make that happen. It’s not one single company, it’s got to be a number of the companies that are all out there helping to get the community and the patients comfortable that yes, you can go beyond the current paradigm treatment. It takes time. It’s a technology shift. Anytime you’re doing a technology shift, it just takes time and data. 

 

Sharon Bakalash: Yes, absolutely. 

 

Rob Rothman: I’m just gonna pipe in there was one comment, because I agree with you 100%. And from the clinical perspective, I you know, I spend, you know, three days a week, you know, seeing patients, it has been incredibly challenging to convert people from drop therapy to implantable therapies, Durysta, I think it’s a fantastic product. And, you know, I’ve made a comment one of the early marketing pre-meetings for Durysta about how many of my patients what percentage of my patients would be appropriate for a product like Durysta, And the answer is 100%. Right? Every single patient would benefit from something. I think Hari will probably be happy to tell you it’s not 100% and the problem is that getting patients to make this change to make them understand that hey, this is an opportunity for us to get you off of topical therapy. But more importantly, this is the way we’re going to be treating disease in the future. We’re not going to be using drops one Today we’re going to be using things like this. And making people understand that it is a Herculean task. And it’s a conversation with every single patient, and some people will benefit from it and some people are not. And this is just one drug replacement at the moment, we need to be able to replace multiple drugs and have different delivery systems. It is incredibly challenging to get this paradigm shift to occur. It was a little bit different. I think for the anti-VEGF because we had nothing. And now we had something with glaucoma, for example, we have drops that work really well, they’re a pain in the neck, and patients are bad at taking them. But ultimately, they were working. Now we want you to take them less than let us do this minor little procedure in the office, that you know, it’s really, really safe. And yet still patients are resistant. So it’s a huge problem. And I’m sure you know, the payer process was interesting for Allergan, and I’m sure it’s gonna be interesting for everybody who wants to move into these longer-term delivery systems. But the reality is that ultimately, you’re right, it’s better for the patients and we have to figure out how to get them to accept the shift. It’s not easy. 

 

Hari Stavrinadis: And Rob, well, while I appreciate the plug here, I cannot comment any further I’m restricted to on the percent of faces that it’s appropriate for. But to that end, and all jokes aside, I think when physicians start getting used to intracameral delivery, or just even delivery into the eye in general, I think now we’re seeing it in retina. And we’ve seen that there for years. We’ve seen it in cataract surgery, we’re seeing it now and in glaucoma. So across multiple disease states, physicians are getting the opportunity to try these technologies and have an opportunity to really embrace them. So I do think that it’s important that companies like Allergan, like EyePoint. And Aerie I know you guys are trying to get into the space as well. I mean, the more noise that there is out there, and the more the physician see that these therapies can be safe, and also efficacious. That’s what really starts to turn a paradigm. But Nancy, you hit the point, you know, spot on, it takes time. It takes time, and it takes data. And it just takes us this comfort that will come. But we’ll get there. 

 

Sharon Bakalash: Well, I appreciate the recommendation for data in time. Because, you know, those are always things that are needed for education of the market. But as an advice for those who are starting to commercialize, right, with Xipere with Susvimo, what would be your recommendations to them? And that that’s for all, Casey, maybe you should start just for the heck of it. 

 

Casey Kopczynski: Yeah, since we are still well, I should say we’re not in the market yet. With a sustained release product. I can only draw from our glaucoma, topical drop experience. And to say that, you know, early engagement with payers absolutely critical, I can’t overstate that enough. As much as we may not like it, the payers are becoming more and more dominant in terms of how medicine is practiced. And designing studies to show that there is some benefit beyond what they could consider to be convenience for the patient, I think is going to be absolutely critical. They will not pay for convenience and understanding the market and understand who the payers are going to consider to be your comparable and then working with them early to understand what it’s going to take to convince them I think will be key. 

 

Sharon Bakalash: Fair enough. Nancy, any recommendations from your end? Considering you have a few growth in them?  

 

Nancy Lurker: Yeah, I would say it again. And again, these are savvy companies, you know, they’re very savvy. So I’m sure they’re all over this, but health economics data, you just can’t you know, you have to have it with ICER. And everything else. And I would also add, if I could put it just a plug in, I think the more that we can expand how we think about health economics. There’s some interesting paradigms out there now or I should say, modalities about how you think about health economics, it’s got to go beyond just the traditional look, it’s got to look at the impact overall on society, caregivers, ability to work and be a productive member of society. We don’t take that into account. And then also I might add, looking at the impact, in some ways very positive of generics down the road. And taking all that into account. That’s not been traditionally incorporated into health economics. We need to start doing that, because we’re being short sighted if we don’t take all that into account. Unfortunately, the payers typically have a two-to-four-year time period because that’s the average life cycle of a patient and their plans. So that’s what they focus on. That doesn’t help society overall, I think CMS can take the lead and I think the major manufacturers can take the lead in really starting to look at a broader view about how we look at these treatments and the advances that were being made. 

 

Sharon Bakalash: Hari, any insights from your neck of the woods? 

 

Hari Stavrinadis: Yeah, I think, look, it’s a collaborative effort, I think, first you got to train your Salesforce, you got to make sure that they understand your data, they have a way to educate physicians so that they’re at ease. It’s also good to have medical support out there as your questions arise that are beyond the scope of a representative. And then even having things like support, we start talking about the buy and build space, we start talking about reimbursement, a lot of practices have never done this before, right. So unless you’re involved in a large specialty practice, it’s this might be something that’s completely new to you. So to have that type of support, and to have that, you know, multiple layers of support. So it’s not just a clinical thing, there’s some medical, there’s some reimbursement involved, these are all things that practices need help with. So, you know, really take your time with each facet of this, because it’s more than just, you know, showing up with some with some data, there’s a lot of other pieces that come into play. 

 

Sharon Bakalash: Fair enough. So gentlemen and lady, we are at the last group that we’re going to be looking at. And that is titled thinking interdisciplinary. And I want to take advantage of the combination here in the panel, where we have diverse representations from multiple disciplines. We have large and medium sized companies, we have a VC representative, we have a physician, we have a marketing specialist. So for those who are listening, the question number one would be, How and when do you harness input from physicians during the development process of a drug delivery? I would like to ask all of you, as companies and you know, putting your VC hat Rob is is going to be a key here as well.  

 

Nancy Lurker: Sharon, if I can add to this, and speak up, I would say all the time, some of the biggest mistakes that companies have made, is they don’t listen to the customer. And in our case, really, the customer is the physician. And if you’re not listening to what they want, you’re going to make a lot of mistakes as you come to market. So you start early, you embed that into your clinical programs, and get that information built in early, early early. 

 

Sharon Bakalash: Absolutely. Chuck, how do you do this at B+L? 

 

Chuck Hess: Yeah, I think Nancy, you’re absolutely correct. I also think that, you know, one of the one of the areas that we’re really highly focused and we do this across all of our businesses, not only in drugs and drug delivery, but also in our medical device businesses, as well, you know, is we bring physicians to the table and really explore the unmet needs, more specifically around patient engagement. And a lot of what we’ve found through our work is really, you know, the lack of knowledge within the physician community around how to adopt these technology. I think Hari, you hit this on the last question, which is really important, you know, a lot of the effectiveness is how well your staff is, is embedded in the process as well. So it’s not only physician engagement, but it’s all medical practice, participants, you know, and then the other part of it that I think is incredibly important, and I know, you know, patient compliance is really what we’re trying to solve with a lot of the talk of these technologies, but how do we turn the patient into an advocate for their own care, and I think some of these are opportunities that we can look outside, you know, drug delivery, and look at technology in general, in how and how those play a role in engaging patients in their own care. I know, every day that I ended the day I’m looking at my watch and figuring out how many steps I’ve taken, and you know that I get my stand goal. But, you know, ultimately, that’s what this is all about. It’s getting the patients engaged in making sure their drops, you know, are administered on a timely basis and in giving them status updates. And I think those are really important aspects of the whole environment of drug delivery and drug management for these patients. So I think those are some of the things that I think are really important, as we really look at proliferating these technologies throughout the community. 

 

Hari Stavrinadis: You know, Chuck, you’re cracking me up, because, you know, we think about patient advocacy. We did a lot of this work as we’re looking to launch Durysta. And when we looked at patient groups around glaucoma and support So we’re more groups about people whose dogs have glaucoma, and actual patients have glaucoma. So I think when you think about feedback, it’s not just about us getting feedback on products, it’s about us, you know, asking physicians, how can we help you? And how can we help your patients, right? So information comes in many different ways. But I think truly understanding the needs of the patients, and the challenges that the physicians are up against is totally important, and something that we need to continue to focus on. 

 

Casey Kopczynski: I think, yeah, I think, you know, I can hear that answer. I’ve really covered it and no question. The earlier you can engage the physicians seek their insight into what the unmet needs are, the better and then, you know, early early and often, I think, would summarize it best. 

 

Rob Rothman: And I’ll, you know, again, stick my, you know, venture capital hat on here, and my clinical hat say that, you know, obviously, I think physicians are a hugely valuable source of information when trying to plot out a strategy, right. As you know, as Nancy stated, we’re technically that consumer, right, patients aren’t going to get something that we don’t recommend ultimately, the problem is that most doctors, I think, unfortunately, have no idea how complicated and challenging it is take product from the conceptual stage into something that’s FDA approvable. Now I’ve had a painful and grueling insight into that process as a venture capital investor in ophthalmology. And it’s very easy to sit around and say, Hey, this is a great idea, you guys should make this. And I see the corporate wheels start spinning around and thinking, well, that’s $250 million. In six years where the work, we’re not going to do that right now. We’ve got other priorities. But so there’s this mismatch between, I think, a little bit of what we all think is a great idea and what’s feasible to achieve. And, and it’s complicated from the investor level, it’s even more complicated, because you’re getting neurotic not to tout what I do as a venture capitalist, but we’re sort of a funnel, right? We see, you know, in focus has been around for three years, we’ve made 13 investments, and we’ve evaluated almost 300 companies, and being able to try and understand which one of those companies deserve funding in a particular discipline, whether it’s drug delivery or not, is challenging, we have to consider all of these issues, you know, clinical need regulatory, and clinical trial process, and an eventual, you know, corporate involvement and potential, you know, exit into the market. And it’s daunting, right? So doctors are great for giving ideas. But it’s really going to take smart businesspeople to figure out how to make it a reality. I think everybody on in this panel who is, you know, part of our corporate partnership, would be able to tell you what their what their dream product is, and what their holy grail type product is. And yet, I don’t think anybody’s really got it yet. Or if they do, they’re trying to figure out how to pay for it, and how to get it to the market in a way where it’s affordable. And thinking about the regulatory challenges and thinking about, you know, who’s going to pay for it. It’s just an unbelievably challenging process. And I love my physician colleagues. And I’ve been fortunate enough to surround myself in InFocus, with people who make me look like the dumbest guy in the room. And I love that. But ultimately, even though we have all these great ideas, it’s not so easy. So I think it’s important to get back to our input. But I think it’s just important to have smart corporate partners who understand the process, because they’re going to really figure out how to take these things to the next step. 

 

Sharon Bakalash: So, Rob, is there any additional ways to include physicians’ input? Is there a stage it’s too early to include their input? 

 

Rob Rothman: Well, again, I you know, I think that every company has a non-disclosable and non-public, you know, sort of manifesto that sort of says, This is what we want to invest in over time. And this is what we want to see ourselves involved with down the road. And I think they put that in play with a combination of both internal and external development, right? They’ll, they’ll build products internally, and they’ll acquire assets that they think meet that manifesto. And I think it’s, it’s up to them to then go out and either get those ideas from doctors or seek validation that they’re on the right track. So I don’t think there’s ever a point in time when it’s when it’s too early. I think there’s definitely a time when it’s too late. For sure, but I don’t think there’s ever a time it’s too early. But I have to say, you know, including the group of people on here, it’s unbelievable how many really bright people work inside of Ophthalmic corporate, you know, pharma, and technology. And you guys all have done a great job of bringing products to market that have really helped me and my colleagues treat disease better. And I think that the most sort of fulfilling aspect of what I do as an investor is to work with companies that are as motivated as we are to find better technology for patients. So I think that you know, asking doctors what they want and sort of helping to build that manifesto was important. I think that getting physicians involved to help either create clinical trials or test ideas or sort of execute early development activities is a great idea. I think engaging with high quality physicians when it comes to conducting research, to figure out do clinical trials, if these things are effective, I think you need that input along the way. I think it needs to be part of the process from the beginning. And then obviously, you need their support when you release the product. So I think it has to be there in every aspect. And I think that all of our corporate partners, including those here, no, you know who those high-quality physicians are to ask. And I think that they’ve gotten really good advice and will continue to get it because they’re, they’re seeking it out. 

 

Sharon Bakalash: Thank you. So I think we’ll summarize this panel with one question that can be left opened. But I do encourage you to just give me a one sentence for summary. And that would be, If we sit here in a year time, not long from now, what would be the drug delivery scene? What would it look like? What’s next for drug delivery? So if we can summarize this still something that is the next big thing, please feel free to do so? Who wants to start? 

 

Rob Rothman: I’ll start because, obviously, sort of what I do, right? So you know, the summary for my goals, or how I like to see the future is I’ve made it a personal goal, to figure out a way to practice glaucoma from the golf course. Right, I figure if I can…. 

 

Sharon Bakalash: But that’s not drug delivery.  

 

Rob Rothman: It is, it is, it’s I need to be able to, I need to be able to treat patients without actually having them in front of my room and monitor them and evaluate their optic nerve and visual function from a golf cart so that I can get my index into the single digit. So that’s the holy grail for me. But what I think is going to be happening in the next one year, five or 10 years. I don’t know what the timeline is because there’s so many variables involved there. But ultimately, one day, I think people are not going to be taking drops from most of what, you know, glaucoma gets treated, I think that’s what we’re going to see. I think for, you know, just to take it away from drug labor for a second, I think we’re going to have better surgical treatments, I think things are going to continue to improve in ways that allow patients to have lower stable intraocular pressure for longer periods of time without relying on them to put drops in their eyes. I think that’s what we will see. 

 

Sharon Bakalash: So droplets treatment?  

 

Rob Rothman: Well, medical therapy, but hopefully droplets, Yes. I don’t think we’re gonna ever get away from medical therapy. But I would love for it to be droplets.  

 

Sharon Bakalash: Great. In retina.  

 

Rob Rothman: It’s all about glaucoma for me, by the way. So I’m gonna let you. 

 

Nancy Lurker: I’ll comment on retina. And I think hopefully, you’ll see home OCT monitoring, which I think is going to be a major, major advancement and getting patients to be able to monitor their system, central subfield thickness at home, coupled with a potentially for SM app, hopefully will be approved, which is once every four months. I think that’s a big advancement, and then others getting filed. So I think that you’ll see over the next year, put in potentially, it’ll be two years out some significant advances. And I think all that coupled with Susvimo always going to start to change this treatment paradigm in retina. And I think it’s very, very exciting time right now. 

 

Sharon Bakalash: Great, thank you. Who’s next? 

 

Casey Kopczynski: I’ll jump in. Yeah, no, I think I think continued improvements in imaging of the retina, and the application to glaucoma and ultimately, enabling glaucoma neuroprotection trials, you know, maybe or maybe not a year away, but it is advancing very rapidly. And it’s something that’s absolutely needed. It’s, it’s still going to be a challenge to get FDA to accept a structural biomarker for glaucoma. But even if it’s not an FDA central endpoint, just allowing companies to begin to test treatments, based on some output that is more reliable, more consistent than visual fields with would allow us to take a very big step forward to at least starting to test potential neuroprotection agents in the back of the eye. 

 

Hari Stavrinadis: And I’ll jump in and Rob, I hope that one day you could fulfill your dream of treating patients from the golf course it’s going to be a lot easier than what you do now. We’ll just have to meet you there. So hopefully, deliberately will help with that.  

 

Rob Rothman: I need somebody carrying my bag Hari. 

 

Hari Stavrinadis: I got your back, buddy. But yeah but think about the space. And you know, while we’re so excited about Durysta, this is just the first chapter in a sustained delivery in glaucoma. So I think it’s exciting that there’s going to be more products, more attention, you know, more focus on it. And I think competition is a fantastic thing for the space. I think it motivates us. I think it helps us do ultimately what’s right for the patient and come up with even better therapy. So, just really excited about the future of sustained delivery here. 

 

Chuck Hess: Yeah, and, Sharon I’ll just conclude by saying, you know, I think that we’re really on the cusp of seeing a transformation of the market. And, you know, all the things that Nancy and Rob and Hari and Casey, you’ve commented on, really make me incredibly optimistic about what this means for patients, not only in our developed markets, but also those markets that really require, you know, great solutions that don’t have the luxury of visiting their eye care professional, on a routine basis. And I think that’s really where the excitement for me as with all of these, these new modalities, these new treatments, is to see the proliferation of great solutions, whether they be surgical or pharmacological throughout the globe. And I think that that, you know, when we get to that point, we’re going to say, wow, we’ve accomplished a lot of great things in this environment. So that’s really kind of my vision and my hope that we see this here in the, in the not-too-distant future. 

 

Sharon Bakalash: Well, thank you so much, everyone. Thank you for the interdisciplinary discussion we just had with what appears to be really great visionaries in ophthalmology, I one thing that I know for sure is going to happen in the year is another drug delivery symposium, and I look forward to having this discussion in this combination because it’s just riveting. Thank you very much. 

 

Nancy Lurker: Thank you, Sharon.  

 

Hari Stavrinadis: Thanks, everyone.  

 

Sharon Bakalash: And thank you, everybody.