Thank you for standing by. My name is Ian, and I will be your conference operator today. At this time, I would like to welcome everyone to the Aldeyra Therapeutics Achieves Primary Endpoint in phase 3 dry eye disease Clinical Trial conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star one. Thank you. I will now hand the call over to Laura Nichols, Operations Manager. Laura, you may begin your conference.
Thank you, and good morning, everyone. Today, we issued a press release announcing achievement of the primary endpoint of a phase 3 dry eye chamber trial of reproxalap, an investigational new drug for the treatment of dry eye disease. A copy of the press release is available on our Investors and Media section of our website, www.aldeyra.com. The press release contains important information and should be read and considered in conjunction with the slides presented and the prepared remarks made on today's call. With me today to discuss the top-line results is Dr. Todd Brady, President and Chief Executive Officer of Aldeyra. Turning to Slide 2, this presentation and various remarks which may be made during this presentation contain forward-looking statements regarding Aldeyra, its investigational drug candidate reproxalap, and its plans, expectations, and opportunities, including regulatory and commercial activities.
Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Aldeyra's actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These statements are based upon the information available to Aldeyra today and reflect Aldeyra's current views with respect to the future events and are based on assumptions and subject to risks and uncertainties, including the outcome and timing of the FDA's review, acceptance, and/or approval of a potential NDA resubmission for reproxalap and the adequacy of the data contained therein. Aldeyra assumes no obligation to update oral or written statements made today as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements, including the results of operations and financial position.
Additionally, additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the press release issued this morning and in our filings with the Securities and Exchange Commission. I would now like to turn your attention to slide 3 and introduce Dr. Brady.
Thank you, Laura. We really couldn't be more excited to announce the positive results this morning. As I'm sure everyone can imagine, we are genuinely thrilled about meeting the primary endpoint of the trial and look forward to discussing the results further in this call. For just a bit of background, following review of a new drug application or NDA of topical ocular reproxalap for the treatment of dry eye disease, the FDA issued a complete response letter in November of last year, which stated that at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye needed to be conducted. The letter did not identify any other review issues.
Following FDA feedback under the Special Protocol Assessment Program and based on additional comments, we initiated a phase 3 dry eye chamber clinical trial designed to satisfy the FDA's resubmission requirements for reproxalap in dry eye disease. The phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial design, illustrated on Slide 3, was comprised of 4 visits. Visit 1 was a medical screening to identify dry eye patients for visit 2. Visit 2, patients received vehicle before or during a dry eye chamber of approximately 100 minutes in duration. Qualifying patients advanced to visit 3 and were randomized to receive either vehicle or reproxalap 4 times during the visit. The next day, at visit 4, patients received randomized treatment before and during an additional dry eye chamber. 132 patients were enrolled. 66 received reproxalap and 66 received vehicle.
The dry eye chamber, which is included in draft FDA guidance for drug development in dry eye disease, is a rigorously controlled, low-humidity environment designed to exacerbate dry eye signs, evaluated by investigators, and symptoms reported by patients, which typically peak around 40-50 minutes after chamber entry. Unlike field trials, which typically require months of clinical testing and many clinic visits, the dry eye chamber allows for the elimination of variability in humidity, temperature, airborne particulate matter, such as pollen, smoke, or pollution, and other factors known to influence dry eye disease. Most importantly, the chamber allows for the acute assessment of changes in signs and symptoms over a period measured in minutes, in this case, 100 minutes, versus weeks or months in field trials.
The primary endpoint was ocular discomfort score, reported by the patients on a scale of 0 or no discomfort to 100, the most severe discomfort, during the dry eye chamber from 80 to 100 minutes after chamber entry. The FDA considers ocular discomfort a symptom of dry eye disease, and based on our conversations with the FDA regarding the phase 3 dry eye chamber trial protocol and analysis, considers discomfort, dryness, and other commonly assessed symptoms to be substantially similar. Given that there were no sign requirements in the complete response letter required for NDA resubmission, and thus we believe that sign requirements have been met, ocular discomfort was the sole primary endpoint, and there were no secondary or exploratory endpoints.
The primary endpoint analysis was assessed using a mixed model for repeated measures across 5 time points, from 80 to 100 minutes after chamber entry, a period beginning 30 minutes after the second and final dose of reproxalap or vehicle, administered 50 minutes after chamber entry. Based on our conversations with the FDA, the FDA considers symptom assessments within 30 minutes of drug dosing to be unreliable. As can be seen on slide 4, the primary endpoint, the phase 3 dry eye chamber clinical trial, was achieved with a p-value of 0.004. Ocular discomfort change from baseline was lower with reproxalap than with vehicle for all time points within the chamber, and all time points during the primary endpoint assessment period from 80 to 100 minutes following chamber entry.
Throughout the chamber, reproxalap-treated patients reported diminished ocular discomfort, suggesting a prophylactic effect of eproxalap in preventing chamber-associated exacerbation of discomfort. Overall, during the primary assessment period, change from baseline in the reproxalap group was approximately 75% less than that of the vehicle group. There were no safety concerns identified, and reproxalap was observed to be well-tolerated. No patients discontinued the clinical trial due to adverse events, and consistent with other clinical trials of reproxalap, the most common adverse event was instillation site irritation, which was almost exclusively mild and most commonly lasted less than one minute. To our knowledge, the results represent the first positive phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and therefore, we believe that the results are uniquely supportive of the potential acute clinical effect of reproxalap on reducing ocular discomfort.
As illustrated on slide 5, the effect of reproxalap relative to vehicle in the phase 3 dry eye chamber trial was similar to that of the field trial symptom results previously reviewed by the FDA and deemed to be successful as part of the prior NDA submission. The reduction in symptoms across two different clinical trial models is supportive of the consistent breadth of activity of reproxalap in dry eye disease patients. The combination of the two positive symptom trials, in our opinion, satisfies FDA requirements for NDA resubmission. Slide 6 summarizes the basis for resubmission. Specifically, at least one symptom trial was required by the FDA for resubmission. Comments from the FDA on the phase 3 dry eye chamber clinical trial that we proposed were received as part of the Special Protocol Assessment process and from other comments, and the clinical trial achieved the primary endpoint.
Thus, we expect to resubmit NDA later this year. Based on FDA guidance, the resubmission review period is anticipated to be 6 months. We're compelled to note that reproxalap is the subject of an option agreement with AbbVie. The option terms are summarized on slide 7 and include a $100 million exercise fee, less $6 million already paid, and a $100 million milestone if reproxalap NDA is approved by the FDA. In addition to $200 million in other milestones, AbbVie and Aldeyra would share P&L responsibilities in a 60/40 split, respectively, in the United States if the option is exercised. Dry eye disease remains a pervasive and debilitating disease that is growing in prevalence, and the clinical need remains for treatments that work quickly with sustained activity.
Slide 8 highlights the unique rapid activity of reproxalap, which represents a novel mechanism of action that, based on the clinical data generated to date, potentially influences inflammation, vasomotor control, which could affect redness and the sensation of discomfort on the ocular surface in patients with dry eye disease. Today's top-line data suggests that in contrast to currently available therapies that require weeks or months for activity, reproxalap has the potential to reduce ocular discomfort within minutes in a dry eye chamber. As such, reproxalap represents a potential paradigm shift in the way dry eye patients could be treated relative to the standard of care. To Aldeyra's knowledge, in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing redness.
As previously disclosed, we expect that reproxalap, if approved, could be the first dry eye disease drug for chronic administration, with a label that highlights acute and chronic reduction in ocular symptoms and acute reduction in ocular redness, a dry eye disease sign of particular importance to patients. At Aldeyra, we are continually striving to innovate and advance the quality of medical care, and based on the results today, I am happy for the dry eye community, including patients and providers. I want to thank all the participants in our clinical trials, as well as our dedicated employees at Aldeyra for all of their hard work over nights and weekends in pursuit of our noble goal. Operator, I'd now like to open the call for questions.
Thank you. As a reminder, to ask a question, please press star followed by the number one on your telephone keypad. Once again, that is star followed by the number one. We'll pause for just a moment to compile the Q&A roster. Our first question comes from the line of Kelly Shi with Jefferies. Your line is open.
Good morning, this is Kelly Shi. Thanks for taking our question. Just wondering if the two other phase 3 trials are still ongoing, and when do you expect to provide data? Do you intend to include this as part of the NDA package, or have you recently communicated with FDA to see if they're needed for resubmission? And as a follow-up, any potential option exercise or payments from AbbVie on the heels of this data, have you had any recent conversations? Thank you.
Yes, good morning. Thanks for the excellent questions. I want to be very clear, as we've disclosed, we have two other ongoing dry eye symptom trials. The NDA resubmission requirements specify one trial. As I have said on a number of occasions already this morning, we intend to resubmit the NDA, and we'll do that independent of the ongoing trials. I would say that in response to your question about AbbVie, what happens with those ongoing trials is subject to further discussions, with AbbVie. I do think we have a unique opportunity with those trials to potentially amend the protocols, to explore other endpoints, to expand the dataset, which could allow for further differentiation of reproxalap relative to standard of care.
In any case, we do not intend to complete those trials during the NDA review because doing so would require submission of those trials and a potential delay in the review itself. Getting back to AbbVie, as you can read in the disclosed option agreement, we're required to speak with AbbVie about any substantial regulatory or clinical development. We have been happily very engaged with AbbVie. I think they are an excellent partner, and of course, I think we're all very happy about the results today.
Very helpful. Thank you.
Thanks.
Our next question comes from the line of Yigal Nochomovitz with Citigroup. Your line is opened.
Hi, Todd and team, this is Ashiq on Citigroup. Thanks for taking my questions. I just had a couple. Could you sort of remind us of the reason behind the run-in portion of the study with just vehicle? I'm presuming this is important to the randomization, but I'm curious why that was. And could you also remind us of what the definition of qualifying patients means? Meaning, you know, what was the definition or what was the hurdle required to actually include patients in the randomized part? Thanks.
Hi, Ashiq. Good morning and thank you for the question. As is the case in many pivotal trials, particularly in phase three, there is a vehicle run-in component, and that component is designed to typically exclude patients that respond to vehicle. In this case, as I mentioned, for visit two, patients received vehicle before a chamber and in the middle of a chamber. We wanted to make sure that patients qualified for enrollment escalated in terms of ocular discomfort in the chamber. It really wouldn't make sense to enroll patients that had no ocular discomfort escalation in the chamber after taking vehicle. There is your qualification. Patients on vehicle must have had to have escalated in ocular discomfort in that vehicle chamber.
The vehicle chamber also allows us to compare patients to themselves during the randomized chamber, and so forth. So, there's several different advantages of doing that. But I would say the vehicle run-in portion is actually quite common in pivotal clinical trials, Phase III.
Got it. Maybe, maybe a couple quick follow-ons. Could you, could you give us a flavor for maybe how many patients you screened or maybe underwent the sort of run-in portion of the studies before becoming randomized? And then, my last question is, what are the sort of gating factors to the regulatory submission? You indicated you need to talk to AbbVie, but I'm wondering if there are any FDA discussions you need to have before refiling. Thanks.
Right. The first question about how many patients are screened. Typically, about 15% of patients don't qualify in that first vehicle chamber. That is, for whatever reason, they don't escalate. The other side of that coin is that 85% of patients do escalate, and I think that speaks to the noxiousness of the chamber. This is not a pleasant experience. Imagine that sitting on an airplane, flying across the country with two air vents blowing in your face, watching a movie. Most dry eye patients find that experience quite uncomfortable, and I think that's why 85% of patients, even after receiving vehicle before and during the chamber, continue to escalate in ocular discomfort. And I think you can see that in the data on slide 4.
The gating factors for NDA filing, I would say that there are three components to the resubmission. First, obviously, is the clinical data we announced today in the form of clinical study report, and there are various sections of the NDA that are updated as a result of the new clinical data. I think second is an update to the safety database. As I mentioned in my prepared comments, there were really no safety signals in this trial, and what we observed in terms of adverse events is perfectly consistent with all the other trials we've run with reproxalap. So don't anticipate any issues in terms of a safety database update. And then finally, I think there are standard CMC updates, mostly having to do with stability.
As you know, time marches on, and stability studies remain ongoing for quite some time, and I believe those data will be updated, among other things regarding CMC in the package. I don't anticipate this will be a major endeavor. Much of the resubmission we've already begun to prepare. We're fortunate that the FDA's resubmission requirements were limited to a single clinical trial, and therefore, I think we can efficiently resubmit in conjunction with comments and feedback from AbbVie.
Got it. Congrats again on the data.
Thank you.
Our next question comes from the line of Tom Schrader with BTIG. Your line is opened.
Hey, good morning. This is Sung-Lun for Tom, and thanks for taking our questions, and congrats on the data. So just a quick, two quick ones for me. So, first is, could you maybe just comment on, has ocular discomfort been tried or assessed by other drugs in the dry eye disease space? And if so, how does today's results differentiate compared to that? And then the second question is, as the company is preparing for the NDA's resubmission in dry eye disease, I just wanted to hear what your latest thinking on the strategy for integrating results from your allergic conjunctivitis studies, given some similarity in patient population. Thank you.
Right. Good morning to you, Sung, and thanks for the question. I'm a huge fan of ocular discomfort, at least as an endpoint, because I consider it, and I think many patients and physicians, healthcare providers, consider ocular discomfort as an omnibus term that everyone can understand. I think there are other symptoms of dry eye disease that we typically assess, grittiness comes to mind, where it may be a little more difficult to understand or put into context. You had asked about other companies or other products that have used discomfort. There are a couple that come to mind. However, it's difficult to compare them because ocular discomfort in those trials was measured over weeks or months.
Here, ocular discomfort is measured over minutes, which I think highlights the potential unique, rapid onset of the drug that may not be feasible to achieve or obtain with drugs that are currently available. We have attempted to put into context the effect size, that is, the drug minus vehicle, reproxalap minus vehicle, on slide six. And you can see, relative to our field trial, which in this case was 12 weeks, our effect size over 80-100 minutes after chamber entry, which is 20 minutes, is quite similar. Thanks for asking about allergic conjunctivitis. As you know, we've announced 2 positive phase 3 trials in allergic conjunctivitis in the allergen chamber.
I invite analysts and investors to go to our corporate deck and look at the INVIGORATE trials, both of which are there side by side, and compare those results to the results we announced today. Remarkably similar in time course, in effect size, and statistical significance. Which suggests that, although I didn't mention it in my comments today, reproxalap, from a symptomatic standpoint, could be acutely effective across at least two different diseases of the ocular surface. That is dry eye disease and allergic conjunctivitis. Now, in allergic conjunctivitis, we assess itching. That is a subject-reported symptom that is, sort of the classic symptom for allergic conjunctivitis. In our trials in dry eye, we've assessed dryness, and as of today, discomfort, which as I mentioned in my prepared comments, the FDA considers substantially similar.
We now have a plethora of data for reproxalap, assessed acutely based on the subject-reported outcomes.
Thank you.
Yep, thanks, Don.
Our next question comes from the line of Marc Goodman with Leerink Partners. Your line is opened.
Hi, good morning. This is Basma on for Marc. We have a question on the NDA resubmission, particularly on the plan to submit a draft label describing the acute and chronic effect of reproxalap. Do you believe the results of the second ongoing field chamber trial would be necessary to establish the chronic treatment effect of reproxalap, or do you believe the existing data is enough? And we also have a follow-on question.
Basma, that's an interesting question. I think, what actually appears on the label is a subject of negotiation between the FDA and the sponsor. However, as I said in my prepared comments, the typical symptom assessment in dry eye disease is over weeks or months in field trials, and the assessment we announced today is over minutes, up to 100 minutes. And acute means typically within minutes or days, certainly less than a week or two, and that's what I'm referring to when I say acute. What the label looks like, what terminology is in the label, of course, we don't know. But I think the real advantage of the data that we announced today is that whatever happens, the time frame, the time unit in the chamber is minutes.
I think that potentially allows for substantial differentiation between the onset of activity, at least in terms of symptoms and redness, that reproxalap may have relative to a standard of care.
I see. So, do we expect the results from the second ongoing field chamber trial to be done by the second half, or before the submission, or after?
We certainly don't intend to complete any trials during the NDA review process. As I mentioned in response to the first question, doing so would require a submission to the NDA and a potential PDUFA extension. More importantly, we don't need to do that, or at least we believe we don't need to complete any more trials based on the resubmission requirement, the CRL, of the one additional trial. I think the results of the trial we announced today are pretty clear. The trial has been through part of an SPA process. It has been the subject of additional comments received separately from the SDA, across the protocol and statistical plan. We're quite confident, as I hope you can tell, in the ability to resubmit on this trial alone. I would guess that data from subsequent trials would be released sometime next year.
I see. Sorry, our last question is, were there any other secondary endpoints at all assessed in this trial or no? Thank you. That's it for us.
Yeah, that's another good question. We almost always have secondary endpoints or exploratory endpoints. In this case, the only thing that matters is the primary endpoint, based on the resubmission requirements. We were confident that we would achieve that primary endpoint, that based on the data that's been in our corporate deck from four other dry eye chamber trials that we pooled and analyzed using the statistical analysis that we pre-specified for this trial. And so we just selected a discomfort as the primary endpoint. I think that makes the analysis of this trial, not only from an FDA standpoint, but also from an investor standpoint, quite straightforward, and we're thrilled that the results were positive.
Your next question comes from the line of Yale Jen with Laidlaw & Company. Your line is open.
Good morning. Thanks for taking the questions, and congrats on the outcome. Just two questions here. The first one is from the top, from the figure you show that even in the pre-administrating the drug, you already see separations, and obviously, the second dose give a much greater, consistent separations. So, my question is that, for the first part, does that have any clinical meaning or value, even this is not the primary endpoint? And I have a follow-up.
Yeah, good morning. I, I think that's a very interesting observation, and that is specifically that at the first time point in the chamber, which is 10 minutes after entry, and about 15 minutes after the first drug administration, there's already at least a numerical difference between reproxalap and vehicle. That is, the ocular discomfort symptom scores are lower at the first time point than the vehicle's ocular comfort symptom scores. I think the reason for that could be the day prior of administration, that is visit 3, where subjects received 4 doses of reproxalap or vehicle, and probably much more importantly, the pre-chamber dose, which was about 5 minutes or so prior to entering the chamber. And at least in a numerical basis, your point is very interesting in that, rapidly, within minutes, we're seeing a separation between the two groups.
I think that speaks to a potentially acute and a rapid onset of activity.
Okay, great. That's very helpful. And then maybe just one more question here, which is that in terms of the absolute value at the end of the 100 minutes, are you guys gonna review that, or are you gonna present in a medical conference somewhere later, sometime later? And thanks.
Yeah, I expect these results, which, which as I've mentioned, are quite unique and distinguished, will be presented at a major medical conference coming up and ultimately published. And, as you point out, I think we'll have more detail, potentially including results or statistical results by time point, although those are all post-hoc, as I mentioned in my in the comments to the prior question. But I think the results are, are quite clear, and what's so interesting as you get towards the end of the trial or the end of the chamber, as you point out, is that difference overall seems to increase. One reason for that could be that symptoms escalate in the chamber, even after subsequent dosing.
In the very beginning of the chamber, it may be difficult to distinguish drugs or vehicle from drug because the symptoms aren't that high. But as they continue to escalate, distinguishing drug from vehicle becomes a little bit easier. And again, we saw that in the INVIGORATE trials, both INVIGORATE 1 and INVIGORATE 2, with itching and allergic conjunctivitis, a very similar phenomenon in the chamber.
Okay, great. That's very helpful. Again, congrats on the last puzzle you needed to-
Got it.
Five.
Well, thank you very much, Hill.
Our next question comes from the line of Catherine Novak with Jones Research. Your line is opened.
Hi. Morning. Congrats on the data. Just wanted to ask, I guess, a question thinking about how FDA might be looking at this. How does the endpoint here of ocular discomfort compare to the phase 2B endpoint, where you use Ocular Discomfort 4- Symptom Questionnaire? Is this considered, you know, substantially the same? And then, you know, does FDA care about the endpoints being read out at multiple times? You had 12 weeks in the prior study, and here it's an acute chamber study. And then, I have a follow-up.
Right. Thank you to Catherine, and thanks for your early note this morning as well. These are critical questions. One of the first things we learned through the FDA process, and subsequently, I'd say as well, is that the FDA really doesn't appear to distinguish between the typical list of symptoms that every company assesses as part of the ocular discomfort symptom questionnaire, as part of VAS scores, Visual Analog Scale scores, and so forth. And those are typically things like discomfort, dryness, grittiness, stinging, burning. And originally, in a prior draft that we presented to the FDA, the protocol, that all those things were in there. And the general comment from the FDA was, "We don't really distinguish between those." And from patient to patient, my opinion is, those terms mean different things to different people.
That's why I said earlier, I'm a big fan of ocular discomfort, because I think that term is very easy to interpret for everyone. We all know what discomfort is, and that could be perhaps why the data are so strong here, that there is an unambiguous interpretation of discomfort. One of the first things we discussed with the agency, obviously, is, we have a field trial that's been reviewed as part of the prior NDA. We'd like to propose a chamber trial. We wouldn't have done this chamber trial if the FDA had said something like, "You have to do two field trials or two chamber trials." So, I think it's safe to say that we spent a lot of time with the agency in talking about the two different models, that is field and chamber.
As I said in my prepared comments, Catherine, we're quite thrilled to have these two different forms of symptom data, presented to the agency, we hope both wind up in the label if the drug is approved, because it really distinguishes reproxalap from every other, drug that's been approved. As I said, we believe that reproxalap is the first drug to declare symptom as a primary endpoint in a dry eye chamber, which has been in FDA guidance or draft guidance for a very long time. And we're absolutely thrilled to be the first company, and I think to demonstrate achievement of a symptom endpoint in chamber. And I think that highlights the potentially rapid onset, symptomatically of the drug, which is what patients and providers want. No one wants to wait weeks or months to feel better.
We wanna feel better in minutes, and I'm hoping that's what the data announced today support.
Great. And yeah, my follow-up question was related to the acute symptom relief. Can you remind, you know, from a competitive standpoint, what, if any, acute symptom data Xiidra has shown in a, you know, potentially in a short-term chamber study, or is it really just efficacy over a period of weeks?
I'm not aware of any chamber data in a label for a dry eye disease drug. Xiidra, like other currently available therapies, has demonstrated activity over weeks or months. I think all of Xiidra's sign and symptom trials were 12 weeks. Our opinion is that paradigm needs to change. The next generation of dry eye drugs shouldn't focus on weeks or months, it should focus on minutes. And, and so I think, again, the potential for differentiation of reproxalap, if approved, could be quite significant.
Got it. Well, congrats again on the data. Looking forward to hearing more updates, in the second half of the year.
Yeah, thank you.
Our next question comes from the line of Francois Brisebois with Oppenheimer. Your line is opened.
Hi, this is Dan. I'm for Frank. Thanks for taking our questions, and congrats on the data. Firstly, if you could talk about the prophylactic effect that you see in the data. Could you remind us if this was a phenomenon that you saw with the ocular signs in previous trials?
Yeah, good morning, Dan. I would say that the prophylactic effect, and by that, I mean if you administer a drug before a challenge, you see a blunted response relative to vehicle during the challenge. In other words, reproxalap potentially could prevent exacerbation of symptoms, meaning that you may be able to use the drug beforehand, before you feel, before discomfort. And I think that could be quite valuable. The in-chamber dose is designed to demonstrate the opposite, which is, at the peak of symptoms, can a drug diminish symptoms? That's sort of a treatment effect versus a prophylactic effect. I would say the prophylactic effect observed in the dry eye chamber is similar to the Invigorate results, which also demonstrated a prophylactic effect in the allergen chamber, with subject-reported ocular itching.
If you'll notice on slide four, the slope of the line is slightly reduced after entry to the chamber. Compounding that with the effect that Yale mentioned about at the first time point, we have a numerical separation, a numerical advantage of reproxalap over vehicle. That combination should result in a more comfortable patient experience in a setting of exacerbation. We all experience exacerbations in daily life. The dry eye chamber, the allergen chamber, they're considered by the FDA for good reasons. The dry eye chamber is a simulation of experiencing acute low humidity environments, such as the airplane example I gave earlier, exposure to pollen, temperature changes, forest fires, particulate matter in the air. All these things are known to exacerbate dry eye disease, and thus, I think there's real value-...
to showing the potential activity of a drug in a dry eye chamber.
Great, that's very helpful. And then lastly, from your regulatory discussions and also, thinking about clinical meaningfulness, beyond statistical significance, had the FDA required any prespecified difference on the Ocular Disease Impact Scale?
That's a good question, Dan. If you go to the draft FDA guidance, there is no mention of thresholds or threshold requirements. And I think the reason for that, particularly in the dry eye chamber, is that the chamber de facto is clinically relevant for all the reasons that I just mentioned. And, that I'm aware, the FDA certainly has not publicly said, and in our conversations with the FDA, we have no evidence of, threshold requirements for, for clinical relevance, here. And again, I think the reason for that is, de facto, that these models are clinically relevant.
Great. Thank you very much, and congrats again.
Thanks, Dan.
There are no further questions at this time. I would like to turn things back over to Dr. Todd Brady for some final remarks.
Well, thank you all for joining us today. Obviously, we are very excited about the results announced this morning, and as always, we look forward to updating you on future developments.
This concludes today's conference call. You may now disconnect.