Eef Schimmelpennink: Absolutely. Thanks, Tim, for that question. So I think first and foremost, and I’ll get to the other adverse events, the big thing that we’re very pleased with to see in our AE data is that across 30,000 patient treatment days, there were zero serious adverse events. So I think that first and foremost speaks to what we believe the safety of the product and the profile of the product, and it’s obviously different than some of the other products that we’ve seen out there and that’s really truly because of the difference of the mechanism of action of aceclidine and how it does not stimulate the ciliary body. So if you then look at the non-serious treatment-related days, headaches, and some of the other ones that we’ve noticed, again, importantly, they’re 100% or close to 100% are classified as mild.
So in general, we see, and the feedback that we get from patients is that this is a very highly tolerable product, very comfortable with very minor AE issues. To your point, if you compare that to some of the other very successful products, our AE profile is the same, or you could argue, better than those products. You’re asked whether they were transient. So everything that we’re seeing suggests that they are. So we obviously have done our Phase 2 trials. I have a lot of data there and we’re going through the data on our Phase 3 trials now. So if you look at the, what’s called installation site irritation, that’s basically, if you put an eye drop in your eye, some people feel a mild, very brief sting. Think of that as a blink or two and that’s gone.
So that’s definitely transient. The other ones as well, they all go away very, very quickly. Same goes for the headaches. So if you’re one of the few people that actually notice a headache, and again, placebo-corrected, that was about 7.6% in our efficacy trials. So if you’re one of those few people that feel that, they classify it as very mild and something that goes away very quickly. So that may range patient to patient from 10 minutes, 20 minutes to 30 minutes, or maybe slightly more, but it is transient. So it goes away quickly. The data that we’re trying to gather now is to see, is it tachyphylactic? So over time, as you continue to use the product, does this not even occur anymore after, for example, a week? So this is interesting data to look at.
The interesting thing is that we only have very few patients, which is good, that had a headache. So it makes it interesting to look at data and see if we can find any trends. If we do, we will make sure to bring those again to the KOL events in June.
Tim Lugo: Okay. Great. Thank you for the all the detail. And maybe can you just speak to the issues with retinal detachment for some of the other products? And I know it’s — that’s not something that came about in CLARITY. So, hopefully, can you just talk about potential label implications?
Eef Schimmelpennink: Absolutely. So let me answer the label and I’ll hand it over to Marc to explain how our product is different and why we feel we see the, again, very good lack of retinal attachments with aceclidine. But from a label claim perspective, currently, we expect that the FDA will treat this as a class label effect. I think important is that the data that we have, we can obviously share with healthcare providers. We’ll definitely have that discussion with the FDA. But again, currently, we believe that we might have the same general label or class label effect as the other meiotics. But again, the product is a very different meiotic. And Marc, feel free to jump in and add to that.
Dr. Marc Odrich: Thank you, Dave. Thank you for the question. The unique feature of aceclidine is that it spares the ciliary muscle for the most part. And that means it doesn’t cause constriction during a critical part, on a critical part of the eye and that constriction can cause a small amount of traction at something called the vitreous base. So while this is very, if you will, inside the eye and inside baseball, if I can use that analogy, this is something that this particular drug does not do. And therefore, this has a very low likelihood of causing the same kinds of problems that you would see with the drugs that were more popular than this drug, such as pilocarpine and carbachol, which in fact, stimulate this ciliary muscle so that there is traction on this area. So it’s a fundamental difference in our mechanism of action. We are a very specific meiotic, which is pupil selective and avoids the ciliary muscle as a mechanism of action.
Tim Lugo: Fantastic.
Eef Schimmelpennink: Thanks, Marc.
Tim Lugo: Thank you for that.
Eef Schimmelpennink: Thanks, Tim.
Operator: And last question comes from the line of Marc Goodman with Leerink Partners. Your line is open.
Basma Radwan: Hi. This is Basma on for Marc. We would like to ask a question about the survey results performing CLARITY trials where you mentioned that 75% of the respondents mentioned that they will continue using LNZ100. Do you know why 25%? What was the factor that drove 25% to discontinue the drug? And along the same lines, do you think that this 25% is kind of an indicator of the discontinuation rates that you expect in the real world or to expect from the use of the drug? And do you actually have any data from market research or analysis from this ongoing long-term safety data, a trial, I’m sorry, that can give you insight on the discontinuation rates? Thank you.
Eef Schimmelpennink: Thank you. Thank you for your question. Very insightful. So let me kick that off and then hand it over to Shawn for some additional detail. So first, just to make sure that or to clarify. So the question was asked after the study was completed. So patients had their last day of use of the product. We then asked them if this were commercially available, would you want to continue to use the product? So this is not a discontinuation rate in the study by any means. In fact, the vast majority of the patients or the participants completed both the efficacy and the long-term safety studies. And again, that plays to the product being very comfortable, but also very effective. So the 25% that you reference are people that say, yeah, I noticed the effect, but I might not use it going forward.