Good evening, and welcome to Bausch + Lomb's R&D update call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Brent Saunders, Chief Executive Officer. Please go ahead.
Great. Thank you, operator. Thank you everyone for joining us on such short notice. We really appreciate you getting on the call today. I'm joined with my colleagues, Yehia Hashad, our head of R&D, and Mayssa Attar , head of pharmaceutical R&D. We're looking forward to taking you through the presentation and, more importantly, taking any questions you have. Alison, if we could jump to the next slide. Perfect. Today we're sharing results on two first-in-class programs that further reinforces why we believe in our pipeline. First, on our dual-action dry eye medicine. This is the first therapy designed to address both inflammatory and evaporative drivers of dry eye in a single treatment, and we will be moving it into phase III. As you'll learn later throughout this conference call, phase II showed a strong statistical significant effect at day 15, much faster than we expected.
That gives us a clear primary endpoint and a focused design as we advance. Second, on BL1332, our lead ocular surface pain candidate just delivered convincing clinical validation of the TRPV1 mechanism in humans. The result strengthens our confidence heading into phase II readout, which we expect coming in a few months. It opens the door to a broader franchise in ocular pain beyond post-surgical indications. When taken together, these two first-in-class assets represent more than $2 billion in combined potential peak sales, meaningful upside for us beyond 2028. I'll let Yehia and Mayssa walk through the data, but I think the headline is simple. Both programs are going to move forward with conviction. Yehia, I'll turn it over to you.
Thank you, Brent. Good afternoon, everyone. We are really excited to report about these two programs. We will start with the dual -action. Before we dive into the details of the data, I really would like to lead with some of the key takeaways for this program. Obviously, dry eye disease is a multifactorial disease, yet today's therapy generally address one of the driver at a time. This study validates our goal to bring complementary mechanisms together in a single treatment through a novel differentiated formulation that can deliver a high therapeutic effect with a less dosing concepts. The study have revealed a highly encouraging insights. The dual-action eye drops demonstrated a superior effect earlier than what we anticipated, with a strong result at a pre-specified day 15 assessment. Those effects were achieved with lower lifitegrast volume and reduced dosing frequency, supporting the differentiated profile we envisioned.
We are advancing to phase III with greater conviction, a clearer endpoint strategy, and a focused development path. With that, I would like to hand over to my colleague, Mayssa, who will walk you through the details of the study results. Mayssa?
Great. Thanks, Yehia. Hello, everyone. I am thrilled to share our clinical results for our novel dual-action dry eye drop. Let's first start with our program strategy. Dry eye is a complex multifactorial disease. Patients experience similar symptoms, but with different underlying causes. Pure evaporation and ocular surface inflammation are two important disease drivers. At Bausch + Lomb, we have two therapies whose pivotal trials each demonstrated treatment of both the signs and symptoms of dry eye. Their active ingredients work through different mechanisms. We believe in combination, they will deliver superior results. MIEBO forms a monolayer that reduces tear evaporation, while lifitegrast, the active ingredient in XIIDRA, penetrates tissue to act as an anti-inflammatory. Combination products face steep formulation and clinical development challenges. That is why dry eye patients and eye care practitioners do not have one on the market today.
It is for this reason we see a clear opportunity to change that. Combining the XIIDRA and MIEBO active ingredients into the first dual-action dry eyes therapy, simplifying treatment for eye care professionals and delivering better outcomes for patients. Our scientists have cleared the first hurdle by formulating the proven active ingredients in MIEBO and XIIDRA together in a single eye drop, and they have demonstrated those benefits of that combination in non-clinical models. On the left, you see non-clinical pharmacokinetic data comparing how much better lifitegrast, the active in XIIDRA, penetrates ocular tissues when formulated with the MIEBO active ingredient. This matters because lifitegrast needs to penetrate ocular tissues to work as an anti-inflammatory. Drug development breakthroughs often come from finding a way to deliver the lowest effective dose.
With this formulation, lifitegrast reaches the cornea and conjunctiva to ocular surface tissues damaged by dry eye far more efficiently. This drug delivery efficiency is what led us explore in this current clinical study, reducing both the total lifitegrast dose relative to XIIDRA and the dosing frequency relative to MIEBO, aiming to deliver two complementary mechanisms of action in a single, safe, well-tolerated product. Before we get to the results, it is worth pausing on how we dose this novel drug product. The dual-action drop delivered lifitegrast in about a third of the drop volume used in the lifitegrast alone arm. That is 12 uL of dual-action drop versus 35 uL of XIIDRA. We dose the dual -action drop twice daily, so half as often as the PFHO alone arm, since MIEBO is indicated for use 4x a day.
Everything you are about to see, we achieved with meaningfully less drug and less frequent dosing relative to the respective monotherapy. Okay, onto the study design. This was a four-week randomized, double-mask, active-controlled study, and the first time we tested our assumptions regarding the dual-action drop's performance in humans. 443 patients were randomized across six arms. The design included three active arms for statistical comparison and three matched vehicle controls for masking. Our pre-specified primary endpoint was changed from baseline in total corneal fluorescein staining at day 29 versus lifitegrast alone. We chose day 29 because with no prior human data on this dual-action drop, we set our primary time point earlier than the sign endpoint used in either monotherapy's own pivotal trial. We anticipated that combining these two mechanisms would produce a faster effect.
Before looking at outcomes, it matters that patients enrolled across the study arms started in the same place. Corneal staining and symptom scores were well-matched at baseline, and patients came in with moderate to severe disease, consistent with a registration quality dry eye patient population. Additionally, other baseline characteristics and demographics were assessed and found to be consistent across arms. Okay. Now to the exciting part, the efficacy data. Let's start with total corneal fluorescein staining, a sign doctors use to evaluate the health of the cornea. The lower the staining, the healthier the ocular surface. To begin, the study did not meet its day 29 primary endpoint versus lifitegrast alone. While numerically better, it was not statistically significant.
I wanted to lead with that, because what we learned is the superior effect of the dual -action drop is actually faster and evident much earlier than day 29. Here is why we are confident. As early as day eight, the dual-action drop was already pulling ahead of both monotherapies. At the pre-specified day 15 time point, it showed a significant reduction in corneal staining versus lifitegrast alone, with a P value of 0.0007. That gap narrowed by day 29, but not because our effect went away. The dual -action drop's results held steady between the two time points. It narrowed because lifitegrast alone kept improving, which is not surprising. XIIDRA is itself an approved efficacious drug. Ultimately, what we learned was that the dual-action eye drop had a rapid onset of effect, and now we have data to guide when to look for that effect in future studies.
Now let's further evaluate the meaningfulness of this improvement in corneal staining through a responder analysis. We see 41.6% of dual -action drop-treated patients achieved a clinically meaningful three-unit improvement in corneal staining by day 15, more than double the 18.8% treated with lifitegrast alone and ahead of the 31.6% treated with PFHO alone, even though PFHO was dosed twice as often. This result translates the group averages you just saw on the previous slide into individual patients, and more of them experienced a meaningful improvement in corneal health with the dual -action drop than with either of the monotherapies. Again, this was at a fraction of the dose of XIIDRA and less frequent dosing than MIEBO. Now let's examine another responder analysis that tells us how patients feel on day 15.
We know it's the symptoms of dry eye that bring patients into the eye care practitioner's office. A pattern emerges across these individual symptoms we tested. Using complete symptom resolution, so on a visual analogue scale, a score of zero, which for a dry eye patient equates with total relief. The dual -action outperformed numerically lifitegrast alone on every symptom listed in this table. Itching, light sensitivity, blurred vision, irritation, burning, and foreign body sensation. Against PFHO alone, the active ingredient in MIEBO, results are more mixed, better on some measures, comparable or slightly behind on others. But that's still a meaningful result. PFHO is a highly effective treatment and a tough to beat active comparator. There's a reason we don't see active comparators in dry eye trials.
In this trial, we are getting to our result against PFHO while dosing the dual -action drop only twice daily versus PFHO's 4x daily. This head-to-head comparison is exactly the kind of data that will inform the design of our next clinical study. With respect to safety and tolerability, there are no new safety signals that were observed with the dual -action drop or the monotherapies. Overall, adverse events rates were consistent with the established profiles of these two approved medicines. On two specific measures, the dual -action drop looked favorable relative to lifitegrast alone. Instillation site irritation was 11.9% versus 21.2%, and dysgeusia, the altered case some patients report with lifitegrast, was 10.9% versus 15.2%. How do these findings inform our next steps? This first-in-human study didn't meet its day 29 primary endpoint against lifitegrast alone.
But it showed that the dual -action drop works even faster. A significant improvement in corneal staining at the pre-specified day 15 time point with a P value of 0.0007, with the highest responder rate among any arm. That early effect extended to symptom resolution across multiple measures. We achieved all of this with roughly 65% lifitegrast drop volume than XIIDRA and half the dosing frequency of MIEBO, meaning we still have room to optimize our dosing paradigm. This clear fast effect on corneal staining, one of the most important signs of ocular surface health, was achieved at the fraction of the dose and frequency of the two proven drugs, XIIDRA and MIEBO respectively. That's why we have high conviction to advance into the next stage of development with a well-defined path to demonstrate superiority over both individual therapies. With that, I'm going to hand off to Yehia again.
Thank you, Mayssa. Let me transition to the ocular surface pain, a significant and often under-recognized condition across ocular diseases and procedures. BL1332 was built around a powerful scientific premise. Selectively blocking TRPV1 receptors, one of the primary sensors of ocular pain may interrupt pain signaling at its source. This phase I-B study that we are reporting results met its primary endpoint and demonstrated a statistically significant reduction in pain intensity. This validates the mechanism in humans and strengthen our confidence in BL1332's potential as a first-in-class neurosensory therapy of ocular surface pain with unlocking the potential for multiple indications in the future. I now turn it back again to Mayssa to walk you through the results of the study.
Thanks. Okay. The ocular surface, and particularly the cornea, is the most densely innervated tissue in the body. That means it is one of the areas most sensitive to pain. On the cornea and conjunctiva, in the terminals of sensory neurons, the TRPV1 nociceptor is a primary sensor of ocular pain. By blocking, also known as antagonizing TRPV1, we stop the signaling cascade that leads to pain. This is in contrast to the activity of a recently approved dry eye neurosensory agonist, which activates neural signaling. Bausch + Lomb has two distinct TRPV1 antagonist molecules. BL1312 is a first-generation molecule that achieved clinical proof of concept in reducing ocular pain in post-surgical patients. BL1332, which is 100 x more potent water-soluble molecule. Let me share with you data that informed our development strategy. BL1312's clinical experience directly shaped how we developed BL1332.
The graph on the far left simulates human corneal drug levels from two BL1312 dosing regimens. The higher regimen effectively relieved post-surgical pain. A lower exposure regimen depicted by the lower red line tested in a chronic pain population did not. That taught us two things. First, we need a more potent molecule to guarantee sufficient tissue exposure, which is exactly what BL1332 is, being roughly 100 x more potent. Second, we needed to test that potency beyond the post-surgical setting. Immediately after surgery, the cornea's natural barrier is temporarily compromised, which makes drug penetration easier. Outside that setting, with the barrier intact, penetration is harder, which is exactly the scenario a more potent molecule needs to prove itself in. Starting with potency, the center chart here shows why it matters.
In a non-clinical capsaicin-induced pain model, BL1332 blocked the pain response significantly better than both vehicle and BL1312. To de-risk the second issue we have just discussed, we needed to test BL1332 in human subjects who had not just undergone surgery. Those are the clinical data we are going to share today. This was a two-part phase I-B study in healthy volunteers. Capsaicin-induced pain was rated on a 0 - 10 scale, where zero is no pain and 10 is the worst possible pain. Part A in six healthy participants identified the capsaicin concentration that reliably produced a target pain response between five and eight. Part B then randomized 22 participants into a double-masked, two-period crossover. Each person experienced both BL1332 and vehicle on separate occasions. A within-subject design that gives us strong statistical power from this small sample size.
This is the most precise proof-of-mechanism study design that can be achieved in humans. Okay. The result was unambiguous. Our primary endpoint, pain intensity, five seconds after capsaicin challenge, showed a highly significant difference favoring BL1332 with a mean score of 0.6 versus 6.1 for vehicle. This is the first clinical confirmation that BL1332's potent TRPV1 blockade meaningfully reduces ocular pain in humans. Importantly, this pain was induced directly on an intact ocular surface, not a post-surgical eye. Next, I will go through the exploratory endpoints that all tell the same story. 68.2% of participants on BL1332 had complete resolution of pain, a score of zero, compared to none on vehicle, again, with a P value of less than 0.0001. Looking at severe pain.
Not one participant on BL1332 reported high pain, a score of seven or higher, compared to over a third reporting high pain on vehicle. Even looking at the worst moment across the first 30 seconds, not just the five-second mark, the result holds. The same magnitude of difference, still significant. This graph brings it all together. It tracks pain intensity from before capsaicin through 10 minutes after. Pain in vehicle-treated patients spikes sharply and takes minutes to fully resolve. BL1332, the blue bottom line, stays essentially flat the entire time. In practical terms, mean pain duration was 1.6 seconds on BL1332 versus 37.8 seconds on vehicle. Pain that would otherwise last over half a minute was essentially eliminated. Every time point, from five seconds through two minutes, was significant. This is the clearest single picture of what target engagement in humans looks like.
In my career spanning more than a quarter-century, I rarely see efficacy results like this. Like a BOTOX or an EYLEA with such powerful pharmacology that translates to patients. This is where you look to expand to multiple indications where a drug can help patients. BL1332 is that type of drug. On to safety. Zero treatment-emergent adverse events were measured in either eye. No serious events, no discontinuation. At this potency level, that's about the best safety readout we could ask for. It's worth noting that earlier systemic TRPV1 antagonists developed for pain were discontinued due to hyperthermia. Given that history, BL1332 completed a phase I study specifically designed to evaluate systemic exposure and thermoregulatory safety, and it was well-tolerated with no hyperthermia observed. That's consistent with what we'd expect.
Topical ocular dosing produces ultra-low systemic BL1332 concentrations, well below what would be needed to engage the thermoregulatory pathway responsible for hyperthermia in those earlier systemic programs. Now, what does this study add beyond the phase II we already have underway in post-surgical pain that we'll read out later this year? Capsaicin is a deliberately ideology-agnostic pain challenge. It isn't tied to any particular disease or injury process. It tests whether blocking TRPV1 reduces the nerve pain signaling pathway itself. Unlike steroids and NSAIDs, which treat inflammation to indirectly reduce pain, that's exactly why this result is so strategically useful. Every endpoint we measured, primary and exploratory, was significant, which gives us real confidence this mechanism generalizes across pain indication.
It supports evaluating BL1332, not just in post-surgical pain, but across other pain conditions where patients today have limited options, including pain associated with dry eye disease and other acute and chronic ocular surface conditions. This study, in combination with the upcoming phase II data readout, is what will give us the conviction to pursue that broader opportunity and fully realize BL1332 and TRPV1 antagonism's potential across the full range of ocular pain conditions patients face. I'm going to hand it off to Yehia again.
Thanks, Mayssa. Just stepping back, these two programs share a common theme. Each addresses a significant unmet need through differentiated science. The dual-action program has generated clinical evidence that supports a rapid treatment effect and a dose effect relationship that we can build on it with confidence in the next stage of development. BL1332 has delivered clinical proof of mechanism, demonstrating that targeting TRPV1 can significantly reduce ocular pain. Together, these assets reinforce our strategy of translating differentiated science into a value for patients, eye care professionals, and the shareholders. We believe they can become important future growth drivers and further strengthen our leadership in eye health. Next. Before we open up for questions, I really would like to recognize the patients that participated in both clinical studies. They really committed to advance science, especially in the first in-human two molecules.
Second, I really would like also to acknowledge our investigators with all what they have done in efforts to recruit these patients and keep them in the study for the duration of treatment. Actually, their efforts have allowed us to come up with the results about four months ahead of the schedule. Lastly, but not the least, I would like to thank my colleagues in R&D and clinical development for a well-designed and executed study that were able to give us answers and inform us about how we can move to the next step of development. With that, I would like to actually open up for the questions. Line operator, up to you.
Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using speakerphone, please pick up your handset before pressing the star key. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today is coming from Patrick Wood from UBS. Patrick, your line is live.
Amazing. Thank you so much. Thanks for putting this on. Super helpful. I have two. I will just ask them upfront. Firstly, I guess, how are you thinking about 15-day response times as it relates to patients and marketing and that go to market on that side? How critical that speed of relief is relative to 29-day efficacy? That is question one. Then question two. You sort of hinted in dual -action for you might be able to tinker with the dosing plan. Any thoughts around strategy around that as you move forward and how you are thinking about dosing? Thanks, guys.
Sure. Thanks, Patrick. I will start and then I will turn it over to Mayssa and Yehia to weigh in, at least on the first part of the question with how it stacks up commercially. Day 29, which was the primary, was an ambitious time point for an anti-inflammatory. As you know, the two significant anti-inflammatories are lifitegrast and cyclosporine, and both can take a month or months to show effect. When you see a statistically significant effect at day 15, which was surprising to us, that is important. That is the results I think that matter most to patients and eye care professionals. If you think about dry eye patients do not want to wait around for months to decide if a drop is working. They tend to quit early if they do not feel relief.
A therapy like what we are demonstrating here that shows real measurable benefit at two weeks solves an adherence problem that has plagued the category for years. I think as a patient or an ECP, this would be a very valuable tool in the toolbox with rapid relief. Mayssa or Yehia, you want to?
I think just a couple of things, Patrick. I think one, we need to recognize that the corneal fluorescein staining is, as Mayssa mentioned, indicating the health of the corneal surface. The more inflammation and the more damage to the corneal surface, the more is the fluorescein staining. Less fluorescein staining is meaning that the cornea started to get back to the healthy condition. With the effects that is happening at day 15, that is great achievement, meaning a very rapid onset for healing of the cornea back to its normal state. Obviously, this is supported as well with the responder analysis that we have seen at this time point of day 15. A three-point change in the corneal fluorescein staining gives us, again, another great confidence that this is great news for patients, that they can actually be treated and have a symptom and sign relief at an earlier stage.
The second important part clinically, you have to remember that the anti-inflammatories in particular take time until they work. I am speaking now about the monotherapy, the single agents. We know from the data on XIIDRA, and we know the data from other anti-inflammatory that they could start to work starting from four weeks, and they could have a peak effect at a later time point. This actually has resulted in many, sometimes patient can drop off the treatments if they are just waiting for one week, two weeks, three weeks, and they still do not see a response. Some of them could be dropping off from the treatment. Having this now that we can see this effect at day 15 will be, again, another good reason that the patients have a good compliance on this type of treatment and continue on it.
Clinically, it is a very relevant and it is a very good endpoint, and actually, for our positive surprise, it did even earlier than what we have anticipated in terms of onset of action.
Mayssa, do you want to talk about—
The FDA.
—the strategy around formulation? Yeah, the dosing.
Sure. Happy to do that. Let's take a step back. It's important to remember, and it's a great question. The results we shared today, we achieved with roughly one-third the dose of XIIDRA and half the dosing frequency of MIEBO. That's what the dual -action drop was able to do. If you look at the clinical evidence that's been generated in this study, if you just look at corneal fluorescein staining. In the first two weeks, numerically, the dual -action eye drop is numerically better than both these approved medicines. For the first month, it's numerically better than XIIDRA. That's a fantastic result. Then we showed additional efficacy results that give us high conviction with the performance of the dual -action drop. Another point is that when you look at the tolerability, it's very acceptable. In fact, in some numbers, we're numerically better than XIIDRA.
When we look at that evidence, we know that moving forward, there's many levers we can pull. We can think about the dose of lifitegrast and would we want to optimize for that, and there's also the dose frequency. We have a lot of flexibility to amplify those efficacy results that we saw. We'll share that final phase III study design at a later date. Right now, we're taking these data as well as previous clinical experience and using a modeling and simulation strategy to optimize the dose and dose frequency we'll take into phase III.
Thanks, Patrick. Operator, next question.
Thank you. The next question will be from Larry Biegelsen from Wells Fargo. Larry, your line is live.
Hi, this is Simran on for Larry. Thanks for taking the questions here. Maybe just to go along the lines of the prior question around how you're thinking about commercialization. As you move into phase III, how are you thinking about differentiating this combination from XIIDRA and MIEBO individually in the eyes of both physicians and payers? And does that positioning give you added confidence in the program?
Yeah, it does. I think obviously we have to produce more data, but with the data we have today, I think it's quite clear to me how we would position this initially, which is against the anti-inflammatory category, both XIIDRA and the cyclosporine medicines that exist out there. If you think about the rapid onset, you think about the tolerability, and then you think about the combination, that would be the best place for us to promote to patients because they would get the most immediate and rapid benefit from this type of medicine. I think over time as managed care and access is built. Remember, by design, these are superiority studies or contribution development studies, so payer discussions should be more straightforward, but that will still take some time. I think our goal would be to make this first-line therapy and standard of care.
As a healthcare professional in this space would tell you, they'd love to have both an evaporative and anti-inflammatory on board with compliance and persistence. This medicine should be designed to give them exactly what they want.
Okay, thank you. The next question will be from Joanne Wuensch from Citibank. Joanne, your line is live.
Thank you, and good afternoon. Two quick questions. It was unclear to me what the control arm was in the BL1332 you described as a vehicle. I was hoping you could clarify that for me. Then I will give you the second one upfront. A very elaborate analyst meeting in the fall talked about a three-year plan. How do each of these products sort of fit into that? Are those contributing before the three-year plan, supportive of it, or is this post that plan? Thank you.
Yeah, absolutely. Maybe I will take the second part first and then ask Mayssa and Yehia to talk about the control in BL1332. Joanne, you are right. We did put out our three-year plan last November at Investor Day. To be fair and to be clear, these programs won't launch until after we have achieved or exceeded that plan. The only real impact during that period of time is the cost of the clinical development, which we have anticipated and had planned for success. This changes nothing in our three-year plan. More importantly, I think it shows that beyond the three-year plan, there is strong durability in our pharmaceutical business and big upside of growth with these two assets coming soon after the plan is completed. Does that answer your question, Joanne?
Yes. Thank you.
Okay. On the control arm on BL1332—
Yeah. Mayssa, would you like to comment on the control arms and just the masking purposes for that?
Sure. In BL1332, the ocular pain study, the vehicle was essentially a placebo. What it was everything in the BL1332 eye drop except the active. As you know, in pain, it is notorious for a placebo response. That really underscores the power of BL1332, that it was not hindered by any placebo response. It was truly differentiated in pain relief.
Thank you.
Great. Thanks, Joanne.
Thank you. The next question will be from Aidan Leahy from Bank of America. Aidan, your line is live.
Good afternoon. Thanks for taking the questions. I guess on the first one to level set, can you confirm that your conversation with the FDA gave you confidence that they are fine with a 15-day endpoint for the phase III? I will ask my second one up front. I guess while a fixed-dose combination offers the convenience benefit, how big of a deal is it for physicians to be able to flexibly manage each dose independently? Is that something that you would think will be completely overcome by the convenience factor, the dosage, and the earlier impact? Thanks.
Yehia, you want to talk about the 15-day?
Yeah, sure. Let me speak about the 15-day very clearly. I guess there are two points here. One is the total corneal fluorescein staining being changed from baseline is an approvable endpoint. The answer is yes, has been used in a lot of products that got to the market approval, and it is a very common endpoint to be used. Second, have any product been approved before using 15 days? Yes. But the 15 days with the corneal fluorescein staining actually will be the first time, and this is actually because no product before has achieved total corneal fluorescein staining as early as 15 days.
If I could, Aidan, I would say the reason people don't do it is it's a really high bar to get to 15 days.
Yeah.
Which is why we were so surprised, pleasantly surprised by it.
Majority of the 15 days were symptoms before. You could expect in 15 days you should have a little bit of improvement symptom. But it's the first time to demonstrate corneal fluorescein staining with a responder analysis of three or more step better at a 15 day, which makes us. Again, we will speak with the FDA, but I don't think that the FDA will have issues with having something like this.
Again, from a patient's perspective, that's what they want.
Yeah.
With the second part was on a fixed dose versus the individual elements. First, for those doctors or professionals that want to do it, they will always have the two individual drugs to use. That being said, having been in this space for a long time, at my predecessor company and here, I can tell you overwhelmingly what ECPs want is a fixed-dose combination. No different than many other conditions where, whether it be hypertension or glaucoma or COPD or asthma, where you have multifactorial diseases with different etiology. They want to solve the problem for patients in the most efficient, effective way that ensures compliance and persistence. A fixed-dose combination is that easy button for this disease.
Thank you. The next question will be from Tom Stephan from Stifel. Tom, your line is live.
Great. Hey, guys. Thanks for taking the questions. I will keep it to one. Just on dry eye, I get the comparisons against XIIDRA, but the dual -action dry eye data, it is generally either I think inline or worse than the MIEBO, which obviously has seen some really solid success over the years. Brent, maybe for you, what is the value prop of this combo drug if it is not meaningfully better than MIEBO, including from a rapid onset of action standpoint? I think we have seen some data on that from you guys. Is it the twice-daily dosing? Maybe talk about just where this product fits if it is not really better than MIEBO.
Yeah. I do not want to take issue, but I would say that the framing of the question perhaps is a little off, with all due respect. Look, MIEBO is a terrific drug, and obviously you see it in the numbers of TRx every week. Andrew and his team have done an amazing job with that, and patients and ECPs love MIEBO. But MIEBO is not solving the entire spectrum of the disease. It is creating a healthier tear film by preventing evaporation. But most patients still have inflammation. This is a way to solve both of those in one easy-to-use medicine. It is better than MIEBO in that it is solving inflammation, where MIEBO is not. But I would ask Yehia to weigh in, too.
No, I think that is absolutely right, Brent. I think there is also a very important point to realize here is we know very well that MIEBO is really superior when it comes to the efficacy, when it comes to the single monotherapy treatments. In order that we get the dual -action drop to get approved, we will have to demonstrate superiority over MIEBO. The good news in this study, the results before this study, we did not have any information on the fixed-dose combination because this is the first time we see it in human. We did not have a hypothesis on where it can be superior over MIEBO. What came up clearly in this, that there is a potential because there is a numerically better endpoint that shows that consistently dual -action is better performing than MIEBO numerically despite being at half of the dose.
It validates our hypothesis that if we increase the dose frequency for that, we could achieve the statistical superiority of the dual versus MIEBO. By the way, this is a requirement for the approval in phase III. The product will come out, will be better than MIEBO.
Got it. Super helpful. Thanks, everyone, and congrats.
Yeah. Thanks, Tom.
Thank you.
Thank you. Once again, it will be star one on your touch-tone phone at this time if you wish to ask a question today. The next question is coming from Robbie Marcus from JPMorgan. Robbie, your line is live.
Hi, this is Lily on for Robbie. Thanks for taking the question. To follow up on one of the earlier questions, with the new dual-action dry eye product, you will have three pharmaceutical dry eye solutions. How does the dual-action product fit in with both MIEBO and XIIDRA in the portfolio? Is there a place for all three of them? How cannibalistic versus incremental is the $700 million in peak sales?
Yeah. So great question, Lily. There is a place for all three. I think it goes back to Aidan's question earlier. There will be some doctors that want to manage just one aspect of the disease, and there will be others that want to treat for more of the entirety of the disease with dual -action. Our initial approach will be to promote to the anti-inflammatory segment of the market and then ultimately to the entire market. What we know about this market is it is an under-penetrated prescription market. It is a growing market, and it is promotionally sensitive. There is a lot of room for growth in this market. I was with RESTASIS when it was alone and XIIDRA came in and that expanded the market. MIEBO expanded the market and TRYPTYR's expanded the market. Each new entrant here has expanded the market.
Could there be some cannibalization? It's possible, but I think that most of this will come from incremental new growth in the marketplace.
Thank you. The next question today is coming from Yi Chen from H.C. Wainwright. Yi, your line is live.
Thank you for taking my question. Considering the fact that XIIDRA's pivotal trial efficacy was measured at day 84, MIEBO's pivotal trial efficacy was measured at day 59. I'm just curious, in the next trial for this dual-action dry eye disease eye drop, even though you are going to pick day 15 as the primary endpoint measurement, will you still measure the efficacy at one month, two months, and three months just to show how the efficacy trend and whether the therapy is suitable for long-term use? Thank you.
It's a great question, and thank you, actually. I just would like to thank you because when we started this clinical trial, this is exactly the data that we looked at. We looked at the individual components time points, and we knew from the preclinical data that our formulation, based on the novel formulation that we developed, that it should be acting faster, and it should be acting better when it comes to dose. Our assumption was that XIIDRA was working at day 84. If it acts faster, we selected day 29. We said it would be much faster than XIIDRA original pivotal studies. But we never anticipated it would be even more positively faster, which is at day 15.
So obviously, the day 15 will be selected as the endpoint as we are moving forward because we think that this is great results, showing their data going all in one direction at day 15 from a responder analysis as responder analysis on the symptoms as well. So day 15 will be selected as the primary. Nevertheless, I think that as is the routine with all clinical trials, we will be assessing further time points, especially when it comes to safety and other things to see also how the efficacy reacts, but the primary endpoint will be selected at day 15.
Thank you.
Welcome.
Thank you. This concludes our question and answer session. I would now like to hand the call back to Brent Saunders for closing remarks.
Yes. So again, thank you, everyone. I know it's a lot of data to digest, but we thank you for joining us. We are certainly available as you digest this for further dialogue with you. Just contact George and Yehia, Mayssa and I or Andrew or others can meet with you to help with any questions you may have. But I hope that after you saw the results of these two first-in-class programs, you share our excitement and confidence in our pipeline and the durability of growth of our company. Thank you again so much for your time, and we look forward to keeping you updated.
Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.