Bobak Azamian, MD, PhD, CEO of Tarsus Addresses Unmet Needs in Blepharitis

Bobak Azamian CEO of Tarsus Addresses Unmet Needs in Blepharitis

Episode 228


In January of 2020, Tarsus raised $60 million Series B financing round to initiate Phase 2b/3 trial in the U.S. of their lead product TP-03 for Demodex blepharitis. In this episode, Bobby Azamian shares his background and path to ophthalmology, details on their clinical trials and practical advice for entrepreneurs.

Interviewer:
Ehsan Sadri, MD

Managing Partner
Visionary MD Eye Laser institute

Guest:
Bobak Azamian, MD, PhD

Co-Founder & CEO
Tarsus Pharmaceuticals

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OIS Podcast Transcript:

OIS Podcast VOG:
Welcome to the OIS Podcast for innovators in ophthalmology. This week’s guest is Dr. Bobby Azamian, Co-Founder and CEO of Tarsus Pharmaceuticals. Let’s listen in.

Ehsan Sadri, MD:
Hi, everybody. This is Dr Ehsan Sadri. I’m a board-certified ophthalmologist here in Orange County, California. I’m actually delighted and excited to bring in my good friend for a long, long time, the CEO of Tarsus, Dr. Bobak Azamian, who is just a savant. I’d love for you guys to know him. For those of you don’t know him, we’ll go through his background and what’s exciting about Tarsus and how they’re making really novel in inroads in ophthalmology. Bobby It’s so good to have you. How are you doing?

Bobak Azamian, MD, PhD:
I’m doing great, Ehsan. It’s just a joy to be able to do this together. I wish we could be in person, but I know we’re limited in this environment, you know? I’m glad that you and all my close friends in ophthalmology and optometry are safe and weathering this COVID storm so looking forward to digging in with you here.

Ehsan Sadri, MD:
Yeah, I owe you a hike. So, whenever that clears up, I’ll take you up on that.

Bobak Azamian, MD, PhD:
Fantastic. Can’t wait!

Ehsan Sadri, MD:
Psyched that you here for OIS, you know, and just to be broadcasting. You know a lot of the ophthalmologists but for those who don’t know you yet, I’m gonna highlight a little bit of your background. Bobby is a Harvard guy. Um, we still love him, but he’s super bright. Good friend. He went to Rice University and then went to University of Oxford. Um, and got a PhD, which I want you to kind of talk to the audience a little about yourself there and then, you know, I’m always curious what makes a physician like yourself, who has a career in medicine, pivot and go towards med device running and serial entrepreneur. So maybe we start with that.

Bobak Azamian, MD, PhD:
Yeah, that’s great. As I learned sometimes it takes folks longer find ophthalmology, and it took me that. In terms of my background, you know, it all, I think, makes sense in hindsight. So, I was always interested in science and medicine and innovation. So, I had the good fortune of being at the early days of nanotechnologies that was becoming a really important new field in the late nineties. So, I worked it at Rice in one of the leading labs, a Nobel Prize winning lab that was a pioneer in nanotechnology, and that led me, you know, away from medicine for a bit. Then coming back to medicine, which was always my goal, and being in the Harvard system and in Boston, it really became clear to me that the way I felt I could have the biggest impact was actually to combine the science, technology and the medical in terms of starting companies and trying to bring new therapies to market. So, that’s a bit of my journey, and it’s been a learning experience. You know, I joke with my physician friends that after my residency, I did a fellowship in entrepreneurship. So, I started out in venture capital, working in a couple of leading early stage venture capital firms; Third Rock Ventures in Boston and then Versant Adventures in Orange County. And that’s where ultimately, I was led to ophthalmology. Through Versant’s leadership there, Bill Link and others I ended up finding ophthalmology. And now, with Tarsus, it’s now looking back, I’ve had some great experiences and developing new treatments for chronic diseases. So, my first company that I founded and led was a company called Metavention which is doing great. A very pioneering approach to treating a couple of large chronic diseases, diabetes and fatty liver, with on off the shelf technology in this case of device targeting the sympathetic nervous system. And I’m happy to report that Metavention is entering its US pivotal trials and on a great path to success there. In a lot of ways that lead me to found Tarsus which I can tell you more about.

Ehsan Sadri, MD:
Yeah, so, you know, we could we could spend hours talking. I remember when you and I would grab beers when you were deep in Metavention and we were just doing a napkin call on Visionary. And, I remember you were one the first people that I talked to about this idea of physicians leading, you know, innovation and really playing more pivotal roles. I’m super excited to talk to you about Tarsus. So, tell the audience why blepharitis. Why Tarsus? Why Demodex? And you know, you want to probably educate about how you pivoted to finding Tarsus with Michael.

Bobak Azamian, MD, PhD:
Yeah so like a lot of things in life it really happened by serendipity. So, I had a really good fortune along the way to meet another entrepreneur who had become a close friend and business partner. And that’s Michael Ackerman who is known I think to the OIS community as Founder and CEO of Oculeve and also Co-Founder and Chairman of Oyster Point. And so, he had had a number of really successful and I think impactful experiences in eye care. We had met actually at Versant were both raising our Series As for Oculeve and Metavention respectively, both neuromodulation companies interestingly, you know, stimulation with Oculeve, the innovation with Metavention. In kind of a sign of how these conferences can be so powerful, we actually were a panel together at a conference. A young entrepreneurs panel, which still qualified for, and we got to talking and grabbing beers and said, well, what if we could take this device like model of entrepreneurship that we know and love so well, and actually focus it on pharma. And what that meant to us was, you know, taking an unmet need that maybe hadn’t been addressed as completely as some so blepharitis stood out. And Michael, having worked in dry eye I think recognized that. Taking a target in this case, Demodex mites, that was very central to the underlying cause of the disease, the type of physiology and also very druggable. And then thirdly, taking a drug and instead of device in this case, into that disease and then finally moving very rapidly and very carefully and ultimately very successfully through clinical trials. And so, with that vision and those four key elements, we founded Tarsus just over three years ago. And I’m happy to report that in the span of just a couple of years, we basically achieved all those objectives in terms of advancing a drug into clinical trials having really clinical data that exceeded our expectations in terms of effectiveness and safety. And that’s allowed us to think even bigger beyond blepharitis but, we certainly know that blepharitis is a huge problem that we’re gonna be focused on for the long term at Tarsus.

Ehsan Sadri, MD:
That’s a terrific overview for those of you listening and thinking about being a serial or start up entrepreneur. Those four key elements I think he just went over; I would write those down. I think, you know, personally, as a physician, I’m really excited because really, there isn’t anything that we have that on label treats blepharitis. We’ve got a lot of, you know, old treatments like ointments and warm compress and the whole Demodex issue is very prevalent. And as you and I have talked numerous times, we have noticed that this is a chronic disease and really affects outcomes both in contact lens discontinuation, but also in post-cataract or post-refractive outcomes. Because the patient doesn’t know, right? They think that something went wrong with the surgery, even though they had good vision intermittently we noticed that in the clinic. So, I’m excited. What do you think the heavy lifting is with dry eyes and as far as bringing people into the tent for treatment of blepharitis focusing on Demodex? What are some challenges there?

Bobak Azamian, MD, PhD:
Yeah, it’s a great point and I think you hit on two of them, actually, that I wanna dig deeper on. So, one is the impact of blepharitis on visual outcomes and I think you hit the nail on the head. There’s both the contact lens discontinuation and actually the visual effects and there is a very high prevalence of blepharitis patients undergoing cataract surgery. 60% of the of the patients undergoing cataract surgery have blepharitis. So ultimately, you know, we wanted to treat a very real condition that had very real impact on patient’s vision and I think we certainly have that in blepharitis. So, this causes a number of different signs and symptoms. As the community knows, the signs are very clear. They’re not only redness and swelling but also, um, different forms of debris and inflammation. So, the collarettes that are seen in the eye care clinics are really the hallmark sign the pathognomonic sign that a patient has Demodex blepharitis. But beyond those signs, there are actual real symptoms of itching and burning and then the inflammation ultimately does lead to blurred vision and contact lens discontinuation and poor surgical outcomes. So, there’s a continuum there, from science to symptoms to visual outcomes, and the other point you hit on and I think is so important, there’s a real parallel to dry eye disease. So, when Michael and I looked at this and now we have, you know, a really expert team at Tarsus. Folks with dry eye and really just depth in ophthalmology broadly from product to market, we’ve all seen that there’s so much learning to be done from dry eye. You had in that condition you know, if you rewind 15 years a condition that was treated with mostly homeopathic over the counter remedies such as artificial tears that now has been transformed with a treatment on now multiple treatments that target different underlying cause of that disease. And so, I think in a lot of ways, we’re benefiting from the pioneering works done on dry eye.

Ehsan Sadri, MD:
Yeah, I think, you know, as you know, dry eyes, a huge problem. And for those that haven’t seen Bobby’s video of the collarettes, I think I think if there’s an academy to be won for short film in ophthalmology you should get that. That made such an impact on surgeons and KOLs in Deer Valley AECOS meeting. I had, like 15 people come up to me like that was really gnarly. That was so, so good. It was so good, so impactful. I encourage you to take a look at that. But dry eye is a massive problem. I mean, it’s so pervasive. It hits things like glaucoma, ocular surface. It affects outcomes in cataracts. It affects Lasik and refractive procedures. 1/3 of our patients in the clinic have dry eyes, and a lot of them have blepharitis and so I’m excited that you’re there. And you know, Michael, like you mentioned earlier with advent of Oculeve and now Oyster point really is really honing in on another pathogenesis of being able to solve this problem. But I’m excited for this because it’s a novel treatment and, you know, the treatment that we have right now is very crude. So, tell us a little bit as much as you’re comfortable on the active product, the wonderful data you’re getting with and also the, uh, the just trials in general. Tell us a little more about that. I know it’s been a challenge with Covid even for myself. Patients a little bit are to get into the clinic. But once this clears, tell us a little about that.

Bobak Azamian, MD, PhD:
Yeah, you know I want to touch on one thing in that video. So that’s been a crowd pleaser and, you know, we’ve benefited from the great media talent in developing that. But I think it illustrates a very important point of that actually leads into the drug and the trial results, and that’s that we are targeting Demodex mites. I don’t think I went into as much depth there. But these mites are actually living in our eyelids. They cause about 45% of the blepharitis burden. So about 45% of blepharitis is caused by Demodex infestation. That visual and visceral imagery that we did in that video, I think, is so key to understanding the underlying disease and also understanding how to diagnose and ultimately treat these patients. So, another time we’ll be able to show that video at a future OIS but the Demodex infestation and that leading to collarettes is really the key inside and I think theme throughout Tarsus’ work. So in terms of the drug as mentioned, we really honed in on Demodex blepharitis and sought to find the very best drug that existed for the treatment of Demodex. And I’m happy to report that we have that. So, I can’t say too much about the actual drug. But when I can tell you is, it’s yielding tremendous results in our clinical studies. So, we’ve actually completed five Phase two studies already, and that’s kind of better the theme of advancing rapidly in the clinic like we often do with device companies but in this case, doing in the careful way with the drug. And so, we’ve done a series of Phase 2A and Phase 2B studies and Phase 2B randomized studies, and we’re soon publishing the results in a study called Jupiter. What we found there is really three things, a rapid response, a complete response and a durable response. And all of that with a very clean safety profile. So, our drug TP-03 resulted in statistically significant improvements in collarettes by day 14. So, a very rapid response, a very complete response in that 95% over 95% of patients had improvement of two or more grades on a four-point collarette scale by the end of the treatment at day 28. And then very durable response in that we’ve seen these results last for at least two months after treatment was stopped. And so that complete, rapid, durable effect it also applies to the mite counts. We’re looking at the average mites per lash upon epilating a lash and simply looking at mites under the microscope. And again, we see a statistically significant difference a day 28 actually a tenfold improvement from baseline, with an average of only 0.2 mites per lash by the end of the study, starting with about three mites per lashes beginning of the study. So, that rapid, complete, durable efficacy is what we’ve seen time and again. Yeah, we haven’t seen actually any treatment related adverse events, and we’ve seen very high tolerability for our patients. So that gives us a lot of confidence going into our Phase 3 study and beyond. This is gonna be a really transformational treatment for blepharitis treatments and specifically Demodex blepharitis.

Ehsan Sadri, MD:
Yeah, I mean, and you know so to dovetail on that on the blepharitis story, you know there’s a lot of overlap with Rosacea and MGD. Can you tell us a little hint? A little bit of where you might be focusing any Phase 2 studies there.

Bobak Azamian, MD, PhD:
Yeah, it’s interesting. As an internist, I didn’t know about blepharitis or Demodex coming into this. But when I did some homework it was clear that Rosacea is a huge unmet need. It’s actually caused by Demodex in a lot of the same ways and as I just think about it, Rosacea and blepharitis are continuum, right? It’s the skin leading to the eyelid, so naturally we’re looking at Rosacea and MGD. There’s a lot to learn from Rosacea and a lot to do in Rosacea and MGD. So, we do plan to initiate Phase 2 trials and those indications later this year. We were fortunate to close a $60 million Series B financing led by really world Class eye care and specialty pharmaceutical investors. And I know Ehsan you’re very familiar with some of those, including Visionary Ventures and certainly Bill Link’s firm Flying L and then Vivo and Frazier who were two of the longest running, um, most successful specialty pharma investors. And so that financing really allows us to not only advance the blepharitis product into Phase 3, but also to complete Phase 2 trials in MGD and Rosacea. So, stay tuned on that, and frankly, there’s more to come. So, we have even broader opportunity beyond eye care and dermatology as we look forward to what is a very focused approach focused on unmet needs, focus on rapid clinical data and really transformational treatments. Stay tuned on some other pipeline opportunities to come for Tarsus.

Ehsan Sadri, MD:
So, lets pivot on that because on OIS Podcast here what we really like to talk about is the science and we all love to geek out on the science and how the science helps our patients. But I really want to pivot. If I’m a young Bobby, you’re still very young, by the way, but if I was a younger Bobby and I’m trying to become like you, one of my sort of passions is What are some recipes? What are some clues that you can sort of transfer to the folks that are listening to this? I mean, you guys, he raised 60 million in an environment that is, you know, not easy. I mean, you know, the if you think about that, the timing was great, but that’s a large figure. And really, at the end of day, I think there’s a lot to be learned about how to do that in a new novel disease state with no track record. So, not that you don’t have a track record, but the actual disease state treatment doesn’t. So, that’s a gift. And how do how do you do that? How do you go from where you were to where are now, can you give us some insight there?

Bobak Azamian, MD, PhD:
Yeah, Yeah, that’s a great question. And I’ve been thinking about it personally for over a decade since getting into entrepreneurship from medicine and certainly have a lot of physician friends who, um, wanna get in entrepreneurship and I think have great potential to achieve a lot as entrepreneurs. So, there’s two themes that I always come back to. They always haven’t been intuitive for me personally. I mean, one is maybe an obvious one and that is just surround yourself with great people. And then it takes, I think, two different avenues. One, um, is I’ve always had really strong Co-Founders. So, you know, Michael Ackermann certainly is a great business partner and friend, and I think we’ll do a lot of things together in the future. But on all my companies, I’ve always had really strong business partners, and I think one plus one equals three in in terms of actually having a strong business partner, co-founder. It’s a lonely thing to found a company. So, I think starting with just who you surround yourself with is important and then certainly bringing the very best people to your company. People who are, you know, much better than you and much more expert than you in the different areas makes you strong. And that goes from board members to investors to everybody that you bring into your company advisers and employees and in all your partners. So, this may be an obvious one but look, I think we start companies for two reasons. In my view, one is we have a problem we’re very fascinated about and passionate about and two is we want to work with people we want to work with and in startups you can do that actually and uniquely. So that’s one theme. The other is just be patient. I mean, this doesn’t happen overnight. It seems like there’s lots of overnight successes and startups, but it takes, you know, often years, sometimes the decade to advance the new therapy. And so, you know, in terms of people wanting to become entrepreneurs, you do that because you have a sense of urgency and you want to change the world. But you have to be patient and you have to be methodical. Certainly be aggressive, but you have to be patient, have success. So those are two themes I guess I would I would advise people about who want to get into this.

Ehsan Sadri, MD:
Yeah, I mean, and I think it’s remarkable because I think you nailed it. Have to be very patient, and I think part of the problem that I see, and I don’t know if it’s just a generational thing or because of the you know, the iPhone generation. I see the distraction. I think it’s really important to focus. To put your head down and grind, even though it’s boring and laborious. And being an entrepreneur, you know, sounds flashy and exciting initially but when that wears off, you really have to be patient don’t you?

Bobak Azamian, MD, PhD:
That’s right. There’s a lot of highs and lows and I think as Bill Link has put it there’s, you know, at least three near death experiences that any startup goes through and there’s probably more, you know. Even on a daily basis you’re thinking, how do I get around this challenge or get over this hurtle and so actually being persistent and having that force of will to get things done. A startup, it takes time and it doesn’t all happen overnight. But then, you know you have these really amazing highs, like when you get your first clinical data or when you get people like you Ehsan, excited about this and start to, you know, disseminate the message in the ophthalmology and optometry communities. So, there’s a lot of highs along the way, but it’s almost like doing research or I’m sure starting practice. There’s just a lot of, you know, grinding it out as you said, that’s required.

Ehsan Sadri, MD:
Terrific. Any parting words for our young listeners and listeners in general who are interested in pursuing a…Do they need an MBA? How did they learn the business stuff?

Bobak Azamian, MD, PhD:
Yeah, I think it takes a village to use the phrase. I think, you know, entrepreneurs can come from any different background. It could be, you know, businessperson who just recognizes a market opportunity and an unmet need. It t could be a clinician who recognizes is a better way to do a procedure or a better way to treat patients? It could be a scientist, right? Says, I’ve got this great discovery or an engineer and just make sure you get out there and talk to people, partner with people and realize you can’t do it all yourself. So that’s probably the best advice I could give is don’t be shy. You know, people will help you that you show that passion and you have a really important new idea, a new technology that you want to bring to market.

Ehsan Sadri, MD:
It’s a pleasure. Have a great day.

Bobak Azamian, MD, PhD:
It’s been a real pleasure.

OIS Podcast VOG:
We hope you enjoy this episode of the OIS podcast. Listen in for more episodes with the movers and shakers in ophthalmology and keep an eye out for our new virtual OIS – a series of online showcases featuring a selection of the most exciting therapies and development to address glaucoma, dry eye, presbyopia and retinal degenerative diseases. If interested in presenting in one of our upcoming showcases, visit OIS.net and click get involved.

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