Recently, we were honored to have the opportunity to have a conversation with Paul Smith, president and chief operating officer of Orasis Pharmaceuticals, about the company and its recently approved pharmacologic for presbyopia treatment, Qlosi.

Dr. Loh: Paul, congratulations on what is obviously a huge milestone for Orasis, the FDA approval of Qlosi. To begin, how did you come up with the name?

Paul Smith: We’re very excited to have an approved product to introduce to the market, which as you noted is named Qlosi. Naming a product has evolved over the years. When I started my career in eye care more than 20 years ago, there was more room to work. But it’s evolved into quite a scientific process, where we pull in outside counsel, and ultimately names have to pass through a number of screens. Things like trademarks that avoid confusion—they either look like or sound like something that already exists or could be misconstrued based on how they’re written. And lastly, they can’t make any false claims about the product. So there are criteria we all have to live by.

But in our case, in the category of presbyopia, we were really looking for something that was both short and memorable—something that would connect with providers but also patients, something they could relate to. We circulated names among our many advisors before we went into formal research, and we heard much of the same: something short, something memorable. And we were delighted that Qlosi passed muster, not only among our advisors but certainly at the agency as well. So it’s short, easy, and consistent with the indication of our brand. Qlosi, as you might conclude, helps you see up close.

Dr. Lang: I think doctors don’t really know, or think about, how much goes into a name, getting the name FDA approved, as well as the product. Being a small startup, in a small but growing area of eye care, a new market, and kind of a small company, what sort of challenges has Orasis faced bringing this novel treatment to our refractive-error patients?

Paul Smith: With any startup in the beginning, before you scale, which every company needs to do at the appropriate time, the challenges as a small organization are getting all the various and diverse things done. It’s just being resourceful. It’s critical in the beginning when you’ve got fewer people. Also, understanding who are the right partners, certainly on the strategic side—when do you bring them into the conversation and into the fold? What’s the right time for them to contribute? And the other thing is not being afraid to ask for help. I’ve learned over the years it’s really important to phone a friend when you need one. That can save you a lot of time and expense if you take the opportunity to reach out to someone who maybe has traveled the path that you’re on.

The other thing is about being choiceful. In addition to being resourceful to get the things done that need to be done, it’s also knowing what not to do, or what not to do right now, with limited bandwidth. It’s bringing together the right people, who ideally contribute energy to the cause. They’re net gainers vs energy drainers. Some people are just wired to build things, and you get to know those people throughout your career. Certainly, I’m wired that way, and bringing others together who are inspired by those things is a lot of fun.

And the last piece I would say is culture. When you go into an organization that has already existed, there’s a culture that’s already there, and you kind of assimilate into it. You may influence it, but in the beginning, as you’re forming a new company, you really get to lay the foundation for what that is. The handful of us that were here early on decided it was really important to put a stake in the ground about who we want to be, as we grow up as a company. And this idea that you’ve seen in much of our communication around reshaping vision possibilities is the mission around which we all rallied. We aspire to be a place that really celebrates disruptive thinking, and we want to attract talent that is similarly inspired by that same purpose, and it’s really been a lot of fun. But those are the kinds of things that we tackle early on.

Dr. Lang: This would resonate a lot with eyecare professionals, especially small business owners who are trying to decide how to navigate the big waters that we live in in health care. It’s interesting to hear some similarities from a pharmaceutical company being a small, nimble, culture-focused organization that’s developing and building and trying to do it their way.

Dr. Loh: Before we get to Qlosi itself, would you talk a little more specifically about the team at Orasis that helped get you to this point?

Paul Smith: We consider ourselves small but mighty at this point. We really have been able to assemble a group of seasoned veterans from the eyecare space across all our core functions, including commercial, medical, and clinical. And each of those folks wears multiple hats. So we get a lot done despite the fact that we’re few in number.

When it comes to the commercial side of the business, as we begin to scale, that’s what will become more visible. We’ve been able to hire a team that has experience, starting at the large eyecare strategics—whether that’s Alcon, Allergan, Novartis, Johnson & Johnson—all places we’ve had the opportunity to go to school, so to speak. But each member of the team has prior startup experience, which is really important as you navigate the unique challenges that come with small companies—people who’ve traveled that path and been battle tested, but also have the large multinational company experience to understand what it takes to really align around launch excellence, sophisticated roles, and responsibilities.

Really, it is ultimately around talent, and we’ve got a group that is resourceful, nimble, and strategic and come to work every day looking to contribute to something larger than themselves, which is an important foundation as we transition into launch here during 2024 and add to the team.

Dr. Lang: So Paul, let’s get into it. Brag about your baby that you’ve been working on for the last few years. Tell us everything about Qlosi.

Paul Smith: Qlosi is the next entrant into this new category: presbyopia drops—pharmacologic management of refractive disorders, starting with presbyopia.

What’s unique about Qlosi is that it’s the lowest-effective concentration miotic for presbyopia. So that means we bet on the low dose early on to achieve the ideal balance between efficacy and tolerability, considering the category and the types of patients engaged here. In our phase 3 clinical trials, Qlosi delivered functional near vision as defined by 20/40 or better at near for more than two-thirds of the patients over an 8-hour time period.

That optimized formulation is really allowing us to maximize efficacy and minimize side effects, as we’re formulated at a near neutral pH of approximately 6, along with 2 lubricating agents. All of that helps with bioavailability and great tolerability.

Specifically, as it relates to the patient experience that you can expect as you’re counseling your patients, Qlosi demonstrated minimal side effects, with headache only at 6.8% and instillation site pain at 5.8%. Only 1.3% of all patients in the study had moderate treatment-related adverse events, and all others were mild. We believe it has a very promising profile to go out and provide you with tools for your patients, as we meet more of them where they are.

Dr. Lang: That definitely sounds different from what we’ve been hearing about pilocarpine in the recent past. And you know, pH, lubrication, and things like that really look promising, so I’m looking forward to taking it for a test drive. And percentages really are similar to, or better than, a lot of what we deal with in ocular surface disease circles.

Dr. Loh: I think it’s super important because the side effects, as we’ve learned from other medications, can inhibit usage. You said it beautifully, Paul. And did you mention that this is preservative-free?

Paul Smith: I didn’t, but thank you for raising this point: it is preservative-free. The product is packaged in convenient single-use vials, which really allows patients flexibility to keep vials in their purse, their pocket, or their desk. This is going to be readily available to use in whatever environment they’d want to keep it.

Dr. Loh: I think this is exactly the kind of drop that you want to have in multiple locations—including one in your purse when you’re going out at night. For artificial tears or other drops that I use personally, I want to have multiple bottles. It’s hard to keep track of just one.

Dr. Lang: It’s nice to see others embracing that preservative-free model, protecting the ocular surface, and caring about the cornea so much.

Paul, you were with Novartis for a while, and that’s kind of a big company, bringing a second-to-market drug, Xiidra, to market. Now you’re with Orasis, a smaller company, bringing a second-to-market drug, following Vuity’s launch and release. Can you compare and contrast some of the things you’ve seen and compare the 2 experiences?

Paul Smith: Sure, there’s absolutely some transferable learning there. The first thing I’ll say is about unmet need. The fact that products continue to launch into the dry eye category is a testament to the opportunity to really serve patients, and presbyopia is much the same. So we’re excited to be next. I’ve had the opportunity to be what some would consider a “fast follower” in a number of launches, where in close succession to the initial launch you come right behind, and really the opportunity is to get smarter every day. You learn from the first mover; you understand what the market will bear and what patient preferences are and how to make it easy for providers. We’ve got a plan about which we’re really excited, but we always reserve the right to be smarter, as we gain more experience, make more observations, and really optimize our own launch based on those learnings.

But ultimately, it comes down to the asset that you have. And as I mentioned earlier, a product with minimal side effects in this category is critical. We believe that’s the name of the game. Whether you’re first, second, or sometime later, you’ve got to have a product that works for the intended patient profile—again, that balance across efficacy and tolerability.

Dr. Loh: That makes a lot of sense. So what’s the launch plan for Qlosi? When are we going to be able to start prescribing it and getting it for our patients?

Paul Smith: We’ve been hard at work now for a number of years putting together a very exciting launch plan. Right now, we’re completing a funding round to scale the organization for commercial launch. There are a number of unique aspects to the plan, as you would imagine, really designed to delight both you and the patients, and we will certainly share more about those as we get closer to launch toward the middle of this year.

Dr. Lang: Great. I like that you’re not showing all your cards yet, but we’ll look forward to things as it grows.

For the final question, you’ve traveled more than most people, even our key opinion leader colleagues and docs who lecture a lot. With your business experiences with all this travel, can you tell us some interesting experiences or some interesting things you’ve seen in all your days of traveling?

Paul Smith: Well, that’s a big one. It happens that Facebook reminded me today exactly where I was on this date 13 years ago. I was living in Chile at the time, which is 1 of more than 40 countries that eye care has brought me to, which has really been a privilege. But Chile is the only country in which I’ve lived outside the US.

So the first part of the answer is about this date 13 years ago. I was floating on a raft in Laguna San Rafael, in the south of Chile. We were exploring a massive glacier. It was an excursion with the team I had at the time. While we were there, a piece on the face of the glacier—they estimated it was the size of a 20-story building—fell off. It was quite fascinating—not something we had expected but quite memorable.

But if social media hadn’t reminded me of that today, I’d give you a different answer. I spend a lot of time reflecting on the things that I’ve learned and continue to learn as I travel and interact. And really, the thing that’s most memorable is the people and the different cultures around the world. As soon as I think about an amazing place I’ve been, something I’ve done, a meal that I’ve experienced or shared, what immediately rushes into my mind is who was there with me. And you realize that, ultimately, if you open yourself up to the way that other people live, even if only for a moment over a meal, being genuinely curious is really what I think leads to connection.

I can’t tell you how many times I’ve been in another country, and they’ve offered to take me to some US fast food chain for lunch, and my answer is always, “Take me where you’d go if I weren’t here. I want to experience what you would be doing day to day.” What I’ve seen without fail, every time you open yourself up to that invitation, there’s a connection that occurs. You learn about people’s history—the commonality that you discover across continents in different parts of the world. In some respects, it makes the world all seem a little bit smaller, of course, still with its complexities. But it’s really something rewarding and something on which I reflect often.

Dr. Lang: That’s a great answer, inspirational answer. We all have a different perspective and a different culture, but we’re all human and headed in the right direction hopefully and all headed in the same direction. Thanks for learning those life lessons and sharing those with us, and thank you for leading Qlosi past the finish line and through FDA approval.

Dr. Loh: Thanks for sharing your journey and Orasis’ journey as well, and thank you for your hard work and your team’s hard work in bringing another product that will help our patients.

Paul Smith: Thanks to you both. Anyone looking for more information on Qlosi or the launch can connect with us by signing up at www.qlosi.com. We’d love the opportunity to connect and the opportunity to share updates, as we move toward launch in the coming months.

 Dr. Lang is the lead optometrist at Associated Eye Care in Minnesota and is the director of the practice’s ocular disease residency program. He specializes in cornea and ocular-surface diseases, as well as therapeutic contact lenses and surgical comanagement. He is also adjunct clinical faculty at the Illinois College of Optometry, The Ohio State University, and Salus University.

 Dr. Loh is a board-certified ophthalmologist practicing in Miami, with a focus on cataract-refractive surgery and dry eye disease. She is founder and medical director of her practice, Loh Ophthalmology Associates, which she started in 2016. Dr. Loh also spends her time as a clinical and surgical attending physician for the Larkin Hospital Ophthalmology Residency program. She is a graduate of Indiana University School of Medicine, where she completed both medical school and an ophthalmology residency.