Developing a Clear Vision for a Clinical-Stage Company with Ben Bergo

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Visus Therapeutics has more than doubled its team in the past two years, including the appointment of six senior leaders in June. CEO Ben Bergo grew that team as the company’s lead product, Brimochol, a prescription eye drop designed to correct near vision loss caused by presbyopia, approached data readouts in Phase II clinical trials.

As Visus prepares to move into Phase III studies later this year, OIS Podcast host Ehsan Sadri, MD, caught up with Ben to talk business and Brimochol.

Of the former, Ben shared how his career has progressed from spinning out technologies for Harvard to leading M&A transactions for Planet Innovation to founding a company dedicated to eye health.

Of the latter, Ben details Brimochol’s strong performance at eight and 12 hours. The product uses a combination of two active pharmaceutical ingredients (APIs): 2.75% carbachol and 0.1% brimonidine tartrate, with 100 ppm BAK. Visus also has a preservative-free formulation in development that does not include BAK.

Listen to the podcast to discover:
• How Brimochol’s API combo achieves such durable response.
• The market potential for presbyopia treatment and how telemedicine can help grow that market.
• Other products planned for the Visus pipeline, including wound-healing leads in preclinical studies.
• More about Ben’s career trajectory, which took him from sunny Melbourne, Australia, to less-sunny Seattle. He also gives advice for emerging entrepreneurs and business leaders.

Click “play” to listen.

Transcript:

Ehsan Sadri: Hi everybody, this is Dr. Ehsan Sadri Board Certified of Ophthalmologists. I’m here in Newport Beach. And I’m really excited about my next guest, who is CEO and really the, you know, Executive Director and CEO of Visus, Ben Bergo. And he’s joining us right now in the middle of a Delta COVID increase as you don’t know where the company is, and the presbyopia space and they have a product, prescription eyedrops being studied for correction of loss of near vision. So with that said, I’m super excited. How are you doing, Ben?

Ben Bergo: Really, really well. And thank you for that introduction. Thank you for having me on today. And as you said, so Visus Therapeutics is a clinical stage company. And we have a lead program in presbyopia, as you mentioned, we have some other assets in the company that we’re working on that are pre-clinical, but, you know, a lot of the focus at the moment for the business is on presbyopia and taking our two lead candidates through this phase two we’re in now and moving quickly into our phase three studies later this year. So very excited with the progress we’ve made in what’s to come.

Ehsan Sadri: Yeah, so I love to like dive in into Visus and for those of you who don’t know, super exciting, huge market, big unmet need, just for me as an ophthalmologist super excited because, you know, we have therapies that we never had, and, you know, they weren’t surgical therapies. But before we get to that, I want to dive in a little bit. But Ben’s background Ben, you’ve had obviously enormous experience in life sciences, you know, before you were executive VP of Planet Innovation, and you know, you were doing a lot of MMA activity, and then you were an Nohla Therapeutics. Tell us a little about your background, you know, where were you raised? You know, tell us I already know this. But for those of you don’t know, your work experience.

Ben Bergo: Sure. Sure. Yeah, so obviously, you know, I’m not from around these parts, you can obviously hear from my accent. So born and raised in Australia, in Melbourne, and we spent the first Yes, 30 years or so my life in Melbourne and studied engineering and finance through college and then worked at a company in Melbourne that developed a range of diagnostic platforms and instruments, and you know, antibody products for the oncology diagnostics market globally and sold their company to Danaher and worked there for a short time. And then for five years in venture capital, and learnt a lot there obviously, about, you know, structuring transactions, doing due diligence, lots of different therapeutic areas, being invested across both biotech and also med tech, and then left there and co-founded my first startup company, which was with some technology licensed from Harvard University into a company in Australia, again, that was actually in the diagnostics field and sold their company in 2015. And then, as you said, I started to do some work in the cell therapy field. And that’s what brought me to the US and did a licensing transaction with the Fred Harch in our licensed from them Phase 2B program cell therapy drug and worked there for a period of time. And as you started off, did some more recent work, you know, banking, licensing and business development, and that’s what brought together Visus, I was working with a couple of companies and met Rob Sambursky, actually, who’s a Board-Certified ophthalmologist, also in working on a number of technologies and was able to bring those in devices to co found that company with Rob and Rhett back in October 2019. So I’ve had a range of operating experiences in both good size, but also smaller companies, but also a good range of capital raising and sort of corporate transactional work, which is necessary, you know, in early-stage businesses to get them going and to bring in the assets and find for partnerships, so good range of experiences to bring me to where I am now.

Ehsan Sadri: Yeah, congratulations on all the developments recently with Visus, but you know, you obviously have a tremendous interest, but also background in life sciences. And, you know, I love it when a company takes the next stage and leap, which is where you’re at now to bring actual official, seasoned leader to take the technology and congratulations to Rhett Schiffman, who was also you know, knows a brilliant MD, who actually ends up you know, who’s their CMO, but also Head of Research & Development, but also, you know, to everybody you’ve brought on, you know, you’re scaling a little company. You know, give a shout out to Carey who connected us is great.

Ben Bergo: Absolutely!

Ehsan Sadri: We had a great job in Vegas, lot of hard work! ASCRS got a great time there. I think I’m still recovering.

Ben Bergo: So am I.

Ehsan Sadri: Burning the candle at both ends.

Ben Bergo: That is very light touchdowns in the evening. Right. And then you’re up in the morning again, and you know, scooting around and 5am-6am. So it’s a, yeah, it’s a long series of days, but some great connections. Great, great. Yeah, obviously great meetings, great networking, good to see people back in person. So that was really good, really good conference recently? Absolutely.

Ehsan Sadri: And you did it, you know what I, for those of y’all just don’t know the company? What do you really done well, and I, for someone who’s really supportive of venture ecosystem for over the last 10 years, I really enjoy seeing companies like yours really with the right team, putting together like KOLs, but really bringing in new insight, you know, from, you know, Dr. Burke, and, you know, bringing in people like, Tim, and just, it’s just really just wonderful to see, because I think at the end of the day, you agree with this, it’s all by your team, right?

Ben Bergo: Yeah, absolutely. I think at the end of the day, you know, there are a lot of good, let me call them, era inventions innovations, and, you know, out there between universities, from inventors in a takes, I think, you know, some early you know, people who identify those and bring them into a company and get that formation going and then that enables you, if you have some good assets and good people, you can attract some good capital, and then you somewhat get that flywheel turning, right, so then you attract more good people with that capital, and you find some other technologies that are the obviously worth pursuing. And again, I sort of think about it as this flywheel once you get going, and you keep on building both good new, excellent people within your team, but also good capital partners enable you to again, you know, both fine identify and bring on board the, you know, the best assets to work on and in develop, you know, high quality drugs that have a big impact. So it’s always wonderful to get going, it’s even better to be expanding the team and start to fill out all those different roles that we need. So far, you know, we’ve expanded rapidly, actually, even just recently, we, I think, 9 or 10 people, at the end of last year, I think now we’re up to 24-25. So we’ve hired a good number of people in the first half of this year to be working on, you know, working on our pipeline, in addition to, you know, the expansion of our clinical ops team to be working on Brimochol. So yeah, I agree completely with, you know, expanding the team, and hiring good people is actually absolute pleasure. And, you know, obviously necessary to keep growing, but I’m pleased to see them come on board and work with, you know, other people within the company, but you know, start getting value from the get-go, it’s great to see in great to have those people on board.

Ehsan Sadri: And, you know, I love what I really enjoyed about what you’ve done is just beyond the team is the molecule. I mean, like, you know, you’ve got a unique molecule that, you know, it can last up to eight hours. And you know, when we looked at that data, you and I talked about this is, you know, your Phase 2 trials, you’re showing the endpoints safety, efficacy, but also just that most patients want. The duration is really important for them, because I think that that allows for them to have the best therapeutic outcomes, but also just they don’t want to have loss of distance acuity, tell me what’s unique about Brimochol and then tell me also, you know, what’s your thoughts on your pipeline?

Ben Bergo: Yeah, so Brimochol is a really unique entrant into this presbyopia correcting eyedrops, you know, category. So it’s a combination of two well-known ophthalmic API’s. So brimonidine tartrate, and carbachol. Carbachol obviously, induces miosis and you would know that well, and it’s still sold today as Myosta, to induce miosis immediately during surgery in a senior in injectable format, it used to be sold obviously, as a softer carbachol, many, many years ago, and we sold like that for decades actually, and then promoted and still today obviously, is marketed by Allergan as Alphagan P, but also marketed by Bausch as ramifying in low concentration. So we’re bringing those two compounds together in a formulated eyedrops in and we went through a number of studies last year. And we have a large number of clinical studies which were conducted prior to viruses acquiring the patents that underpin this, this formulation. And since we require those parents, we went through some formulation changes last year in some PK PD studies in rabbits, and we now have a lead candidate in the clinic, which is 2.75% carbochol, and point .1% brimonidine with 100 parts per million in baK. So that’s Brimochol. And that would, that will give an extended duration. I’ll get onto some of the clinical data in a second. And then, as I public and we may probably for the first time at Eyecelerator. Last week on the on the Thursday, we also have a preservative free formulation in development, which we’ve termed Brimochol. And that’s the same concentrations of carbon column for monitoring but without the end, we have the BaK, so we have those two formulations under study right now in this phase 2, but prior clinical studies, multiple clinical studies out of the six that had been completed prior to us again, acquiring the patents. You know, multiple studies had shown a long and durable response in both fake again, pseudo faking patients actually, up to eight hours and beyond what one one study in 2019 showed a long and durable response after 12 hours in patients improving, I think of five your main five juggle Prove me after 12 hours in those patients at a higher concentration 3% carbachol and .2% brimonidine. But really, with all that prior clinical data and the changes we’ve made, we have a lot of confidence of where we’re taking, obviously, these two formulations, I guess what makes that the combination really unique is obviously the addition of brimonidine. To carbochol being the moronic agent. And, you know, the morning, as we know, you know, widens the eyes, we know that a straight cholinergic agent, straight ionic can create some hyperemia. So we expect to lessen that, obviously, with deviation remodeling, we have some data from a PK study we did last year that shows that in the presence of brimonidine, there’s a 50, about 50% more carbochol in the ciliary body. And so what we’re showing there is the brimonidine improves that our ability of carbochol in any gain VAT net meiotic effect and that pinhole effect. And then we also know from some prior data that the combination of these two provides no change in IoP, sometimes we know that a straight cholinergic can create a change in intraocular pressure, but we’re not seeing that with this combination, which is great. And we also know that again, brimonidine can reduce, you know any spasm of the ciliary muscles, so we expect to see, you know, maybe some reduction, potentially in headache and brauerei come, you know, plus some no loss in distance visual acuity, no myopic shift. So, really, it’s the combination, the benefit of remodeling is multi fold, as I’ve just done highlighted, that is a strong contributor to this, this durable response we’re seeing in patients. And to your other point about duration where we’ve completed a number of, you know, fairly large market research studies now. And in time and time again, duration is the key feature that we’re hearing from patients and also doctors that they want to see in the presbyopia correcting eyedrops, and we think that’s going to be your key defining part of products that are obviously, you know, coming down the pipeline and in through the market.

Ehsan Sadri: That’s great. I mean, that’s a really good for, and I think the sweet spot is eight hours, I think that’s going to be the key and not losing distance vision as a condition. That patient is going to be looking, I think, so let me ask you this, before we jump into the pipeline, how would a patient get their hands on it? Let’s say this flashboard you have this available. with Aiko see their optometrist today. How do you as a CEO? I know we’re jumping the gun a little bit, but let’s talk about that because I think it touches on your market data a little bit like, how’s the patient with telemedicine? Can we set up something where they don’t have to come in and most of them are healthy individuals that probably don’t want to see their ophthalmologists or, you know, probably have never seen ophthalmologist, maybe they see the optometrist occasionally. But let’s face it, they’re like me, they’re, you know, they’re getting older, they can read their book for a five-year-old. And they want to see the best, but not necessarily probably a too busy to go see somebody, how do they get this medication?

Ben Bergo: Yeah, really good question. So you’ve touched on a few topics here, and this is, I think, a really exciting what’s going to be a really exciting wave of new interactions between patients and doctors. You know, if you take, if you take an amateur up now, you know, in the late 40s, early 50s, a lot of those prospective patients have never seen an eye care doctor in their life, and they really haven’t had any need to, and then they develop presbyopia, and, you know, they go and buy a pair of readers, you know, a pair of readers or, you know, maybe they get a nice pair of frames or something. And, you know, in time, they obviously, you know, might do that consultation, but, but you know, a lot of those patients aren’t going to get the right car and kind of eye care that they need. And there could be some undiagnosed cases in there, obviously have other you know, other indications and other conditions that the patients have. And so, you know, in interacting with, you know, with a number of different, you know, doctors over the last six months, you know, KOLs over the last six months, you know, we’ve heard and we can see that, you know, this could be a, you know, this could be a drug that helps to bring patients into the clinic. In the end, it could be something that that obviously, because patients are going to want to learn from this through marketing and advertising, obviously, they’re going to want to learn about this and they’re going to need to go and have a have an eye exam done. It’s going to bring them into the clinic when they wouldn’t have otherwise done that which is normal. And obviously it’s good for you know, for the industry in general. In terms of your question on, you know, your digital health, can you do a telehealth type of exam, again, though, I guess, conversations we’ve had, that’s one potential. So it may be that you do some sort of telehealth exams to do a first consult, maybe provide a prescription For a month, and then you say, you know what, after a month, I’d like to come and do have you come in person and do a follow up after the first month. So you know, you provide a prescription for the drug patient picks up the drug from pharmacy, or uses it for a month likes it, and then actually returns for an in-person console, you know, say after the first month, that sort of model? Yeah, we’ve heard, again, from interactions we’ve had, certainly, I think there will be a large telehealth component to this, this is obviously an indication that you can diagnose remotely. And so I think there will be a component to this, how you then link the ad in to again, in person consultation, what timeframe and how do you bring that in? You know, again, we’ve had a number of different conversations as to how that might work. But yes, I see that as being a part of this. And again, I see this as being overall very positive for industry, because I think that it will bring patients who otherwise you know, do not see any sort of eye care provider either optometrist or ophthalmologist and now, they will be now they will be making those visits to learn about this whole new category of, of eyedrops. And I think that’s incredibly exciting. That gives him better eye care, and obviously opens up the industry further for other, you know, other treatments, potentially too.

Ehsan Sadri: Yeah, so let’s talk about that’s a great segue. So you’re working on the VTI-003, which is a peptide, we talked about in Las Vegas, you know, obviously, what you can probably just kind of, give the synopsis of what’s already out there about what you’re working on without, you know, open up kimono too much. So maybe, maybe you can enlighten you know, folks that are out there, that you do have a pipeline, this is actually a real company, you’re not just one off, and I think that’s pretty exciting. Tell us about that.

Ben Bergo: Yeah, so, what we have made public is obviously we have, you know, LA programming in presbyopia, we have you know, some other assets in the company. Little bit of that we have made public at this point in time and some more we will be making public through this quarter later in the quarter. But to his status, which again, we have been talking about and we actually had some nice data, some preclinical data, which we just got from some early studies, just last week, is a class of peptides, sustanon peptides, the naturally occurring saliva, the peptides that exist in the mouth of humans in non-human primates, they’re thought to be somewhat responsible for some of the accelerated wound healing that we see in you know, oral cavity in history, and one has got, you know, fairly well documented wound healing capability and through to standard five with, again, well documented anti-microbial activity. And so we have a large patent estate around a number of different bodies of research in beginning showing accelerated wound healing with the sustained peptides. And so what we can see is that, you know, potentially this could accelerate, healing after, you know, potentially something like, prk, for instance, it could be used for some different forms of ocular surface disease. So we’ve got a number of different indications that we are looking at, along that, let’s call it you know, in a word healing envelope, evaluate, evaluating that, right now internally, in the company based on, you know, some data indicating we just got last week, which we’ll be making, you know, public fairly shortly. But suffice to say, I see, probably, at least, you know, one, maybe, yeah, maybe two to three, but but at least one and apart from that, you know, formulation and ultimate drug, you know, likely topical, coming out of this standard research. And, again, yeah, we were pretty excited to, again, share some of these obviously, confidentially, you know, last week, at ASCRS with them, you know, with some of our advisory board and get their feedback, and that will help, you know, steer the direction of our development. But we there’ll be some more on that. Let me just say later in the quarter, when we start to make up more of their public but yes, we do have a pipeline, and I’m very excited to actually unveil quite a bit of that, you know, in the coming month or so.

Ehsan Sadri: Congratulations, I you know, I think, you know, having such you’ve been there since 19. They’ve done such tremendous heavy lifting. And, you know, for me at the end of the day, it’s a huge market, huge unmet need and huge opportunities. Give me plenty of business for everybody. Um, you know, I just, I’m so excited. You’re there and you’re focusing everybody, and you have a great team. You know, tell us a little about you. I know who you are now is not who you were 20 years ago, you know.

Ben Bergo: I’ve got lists here. With the same height of I’m showing.

Ehsan Sadri: Yeah, you’re you look good, you look good. Because internally, I think we’re both mean, I talked when we had dinner, we probably think we’re like, you know, in our 20s.

Ben Bergo: We look like 20s. Yeah, yeah.

Ehsan Sadri: I did too. but how have you evolved? And what would you tell a 20-year-old? Who has aspirations to become like you? What are some things that you would like to talk about? You know, what would define it as legacy or coaching or whatever you want to call it? What are some things that would you attribute your success to that, you know, that are really not well understood? And what are your key elements to success in your career?

Ben Bergo: Yeah. So I think if you want to, if you do, no, if you’re, if your career objective is to, you know, is to be in an early-stage company, or start, you know, start an early-stage company and run it, you know, be the CEO, in a senior leader in a business like that, but better to co found something and be the CEO and run it. You know, I think it’s important, it’s not necessary in there are people who don’t, you know, don’t do this or have this. But I think it’s important to have some degree of operating experience. So there are some people who do a lot of research, and they take their research and spin that out of, again, you know, in the University or college and in do very, very well grow companies all the way through to selling them in a incredibly successful. And there are other people, you know, as we know, you know, stories like Facebook, Mark Zuckerberg created Facebook, in his dorm room, and everything else. So that happens, too, but I think, you know, I think on the whole, you know, having an understanding of the different components of business, and actually having some operating roles within business and running projects, or running a marketing function, or being in sales, or whatever, but understanding how the different functions of business work is important. And I got quite a bit of that, you know, in an earlier stage company, which grew quite rapidly, and then became quite a big company before it was. So having that growth experience, through a number of different roles was, I think, was good for me, and gave me some good grounding in both what it is to be smaller, but then go through both and how you know, how you scale, you know, quickly and still make sure you’re delivering quality product, I think it’s really important to think always about the customer. And also, not just the customer or the patient, but also to follow, let me call it sort of follow the money. So you need to be developing things that are important, you know, for the patient or for the doctor, whoever you are in customer is going to be and make sure you really, really understand their needs and spend a lot of time in market research. I’m always a big believer in spending money on market research. And we spent quite a reasonable amount of money on market research as a smaller company. But we’ve done a lot of different research studies. And you mentioned Carey earlier, she’s been, you know, really important in spearheading a lot of that. But to me, as you get more research data, it’s always important to take that and then and then ask yourself, Well, what does that mean, from what we thought the product was for our target product profile? What does that mean? Does it change it at all, in terms of the, you know, the preclinical clinical data, but then you should go back out to the market and do some more research based on that, too. So it’s so strange just be a thing that you do first appears to be a continuum that you’re doing all the time, in learning about the market, make sure you’re addressing those needs, and also just understand how the how the money flows through whatever product or service you’re developing, you know, who’s going to pay? How are they going to pay? Are they going to be happy with the price? Do you think you’re going to need it make sure that you’re not, you’re accounting for the different groups that are involved, you know, if it’s a surgical device you’re developing, who’s actually going to be buying that, and he’s gonna be like that he making a decision in the practice? And you know, have you really spoken to them about how they think about it. So I guess I learned a lot early on in my career, and I encourage people to, to spend some time, either working closely with people in marketing or spend some time doing that directly to understanding that piece. A lot of technologists I’ve made over time, having understood that I understood the market piece well. And so I think that’s a really important thing. Have a mentor, you know, through different stages in my life I’ve had a good mentor, either formally or informally, but it’s always really valuable to have someone who has had different lessons to you has a different network to you and can provide an open door for you to with open up your help open up your network or just be a sounding board at times. And it’s tough to try and solve every problem yourself and deal with every issue yourself. So it’s useful to have one or two or a group of people that are independent of you and confidential to talk to about things that you experienced. So, again, no, I think that’s important. And important to always try and have, you know, again, one to a few people who you can turn to either formally or informally to be doing that. I guess the final thing, I’ve touched on a lot here, but I guess the final thing is two last things, maybe I guess there’s lessons if you do want to be, you know, early stage, you know, having some exposure, you know, either through in my own experience working in venture capital, which was hugely valuable for me to just understand the process of raising capital or doing your evaluations doing due diligence, how does the VC think about due diligence, etc, having that experience has been useful for me, but you don’t have to do that directly. But having some appreciation for what warning an investor is looking for, in getting that learning from someone I think, is important if you want to be in the, you know, in the earliest stage here in the early-stage game. And then finally, I think, you know you need to have, you know, some tenacity and to really, you know, to really dig in and persevere with something, you know, that you believe in, and, and go for it. And, you know, if you’ve got some great skills and great talents, obviously, you can go back and, you know, find another role in the future if you if you don’t succeed, and you’re not always going to succeed, but if you really want to create something and build something, it’s gonna take a lot of, you know, a lot of tenacity and perseverance. So I guess that’s a collection of things that I’ve learned and that always, you know, I would communicate to my younger self, to the learns, learn some of those lessons quicker. So, um, so yeah.

Ehsan Sadri: It was a great pearls. And, you know, I wish we had more time is spent, and we’ll bring you back on as the company matures, and you’re going through your iterations of your data, and it’s just so much great. Well, for those of you listening, or watching this Podcast that, you know, I would really pause in the last five minutes. And that’s, you know, they say, you’ll have to sit, you’ll be the same person, the same future. And the only thing that changes is the people you’ll meet the books you read. And, you know, I will tell you that I will play as a podcast you listen to because I mean, really learn about all the things that you know, you said, and I think it’s critically, because they don’t teach you that stuff. Certainly medical school don’t teach that stuff. And even my kids now I look at the same archaic school system is placed at grade schools, and they’re modernized, but really at the end of the day, all of this stuff really comes down to, you know, all the pearls we talked about as a collaboration. And yeah, you’re listening to everybody. And I think a lot of that is vital. And it’s so many entrepreneurs that I meet that they get married to their, to their own idea, and they don’t listen to market research, your market research might tell you to hang it hard left, and you’re, you know, you don’t do that. And as you know, that could be devastating to accompany. So, yeah. Pleasure, Ben, having you and I look forward to seeing you again, live in there. And I hope you guys stay safe out there with the Delta wave.

Ben Bergo: Yeah, you too. Yeah. And I guess, to everyone who’s watching and listening, you know, stay safe. Let’s hope we have to move beyond this. And yeah, I mean, we said at the start of this, before we got on to this, we’ve changed some policies internally to make sure that we can keep your employees safe and well, and their loved ones. So those to everyone, stay safe. Keep moving forward that to do so with some caution. So thank you for having me. Appreciate the time. Look forward to coming back on at some future point.

Ehsan Sadri: Absolutely Ben. Thank you Have a good one.

Ben Bergo: Thank you.