Orasis Pharmaceuticals CEO Elad Kedar and COO Paul Smith sat down with David Hutton to discuss the FDA approval of Qlosi, a preservative-free low-dose eyedrops for presbyopia.
Editor's note - This transcript has been edited for clarity.
I'm David Hutton of Ophthalmology Times. I'm joined today by Elad Kedar, CEO of Orasis Pharmaceuticals, and Paul Smith, the company's president and chief operating officer. The FDA has approved Qlosi, a preservative free low-dose eyedrops for presbyopia, which consistently demonstrated efficacy, safety and tolerability and two pivotal phase three trials. Tell me what does this approval mean for ophthalmologists, optometrists and the presbyopic patients they treat?
Most of your viewers know, presbyopia is a highly prevalent condition with over 120 million presbyopes in the US. So the approval of a new low dose option, we believe, will allow many more providers to provide an alternative to their patients who are seeking a break from their reading glasses. And as you mentioned, after an extensive Phase 3 program, numbering over 600 patients, we've seen very encouraging results that show that Qlosi will indeed be a welcome addition to the category. As it relates to what this means for Orasis, the company has been hard at work. This was really an exciting time for us as we enter the market with our first asset. So, we certainly look forward to sharing more around our launch plans as we move toward scaling and commercial launch here in the first half of next year.
Tell us a little bit about the mechanism of action for the solution as well as its efficacy.
Sure, I can take that one. So, the mechanism of action is meiosis. So, basically what Qlosi does, it works on the iris sphincter muscle. It basically contracts that constricting the pupil creating what is called increasing depth of focus. And this is what is correcting in your vision. Qlosi can be administered once a day or when needed. It can be repeated for a second time, after 2 or 3 hours, basically, to extend duration out to 8 hours. Qlosi can be used on a daily basis or as needed, but eventually up to twice a day in every day that it is being used. And that is actually very important for the flexibility that Qlosi gives the patient. We know that different patients have varying needs for their near vision. And that flexibility allows them to basically adapt utilization to their own needs and to their own varying needs every day.
On the practical side of things, when will the solution be available for prescription?
Smith: Yeah, so we're, we're planning to make the product commercially available in the first half of next year. Certainly we'll provide more specifics here as we as we near that date.
What steps are being taken to ensure that you can meet the anticipated demand, I'm sure you guys know that this is going to be a pretty hot property once it's released.
Smith: Yeah, so a great problem to solve, as you would imagine. And one of the things that, that we've been very thoughtful about in recent years is managing a very close working relationship with our manufacturing partner. And not only are we very well positioned to satisfy the capacity needs for the market over the first couple of years, our product at launch will actually be made on the very same line that our clinical supply has been made for recent years. So, [we are in} in a very good position from a manufacturing perspective to satisfy anticipated demand.
And this therapeutics for use in adults, is there any potential for an option for younger patients?
Yeah, so presbyopia, for most people tends to begin or at least its symptoms begin to appear around age 40. And certainly it progresses over time. And when you look at the the sort of the 45 to 55 year old presbyopes. That's where we see the highest level of interest and potentially the highest utility. Now, as far as patients, using a product that as Elad mentioned provides a mechanism for pupil modulation or pupil constriction, there are other indications beyond presbyopia that could indeed benefit younger patients. As it relates to the current indication, we expect this to be used by patients at least 40 years old or older.
And to counter that, is there any work on something that could maybe work similarly with myopic patients?
You know, it's not up on our, you know, core activity. We know that there are other products in development by other companies. Our focus now is on the presbyopia we do have other programs in the pipeline for Phase 2, but our main mission going forward in the near future is to launch Qlosi for presbyopia in the US. This is the main target for the company for now.
David, I appreciate the question. What I think it also highlights is we are at the beginning of an entire new category of the pharmacologic management of refractive disorders. So, certainly we're focused on presbyopia, as Elad mentioned. But as doctors, both optometrists and ophthalmologists alike, begin to incorporate this into the regimen, we think this will be a very useful tool for many patients in the market.
What can you tell us about anything currently in your pipeline for this or other conditions?
Yeah, certainly we've looked at the other potential uses, or indications, again for small aperture optics, or pinhole optics, which is what we achieve with, the product that is now known as Qlosi. We have multiple other Phase 2-ready programs, that following commercialization of Qlosi for presbyopia, we'll pursue those INDs with the agency at that time.
And then is there anything else that we should note about Qlosi and it's release maybe that I haven't asked today?
Yeah, maybe one point to highlight is, you know, one thing that right from the beginning, when we developed Qlosi we had in mind, we had the patient in mind. And we knew that, in this category of quality of life, we need to find a product that will eventually deliver an optimal balance across efficacy, safety and comfort. And one of the key ways for us to achieve that was to find the minimum effective dose. Through our rigorous Phase 2 program, we found that minimum effective dose of pilocarpine, which is by the way, less than a third of the concentration, concentration of the other approved product for this indication. And furthermore, we optimized the formulation through a near neutral pH and multifaceted vehicle to deliver this optimal balance of course, efficacy, safety and comfort. This is exactly what patients need. And we do know that the potential of the category is huge. And we know that that Qlosi is exactly what the category needs now in order to really grow and develop