Good afternoon, everybody. Thank you for joining us for this installment of our Head, Shoulders, Knees, and Toes series. This call is somewhat different. I like that. This is part of the Bausch + Lomb research and development teaching series, particularly targeting two areas of contact lenses. One is their Project Halo, the other one is myopia control, both of which were unveiled at their analyst meeting last fall. I think this really provides an opportunity to dig in a little bit more on those products from an R&D perspective and take a look at their development and ultimately their commercial impact. There is a large group of people on this call. Not only do we have CEO and CFO, Brent and Sam, we have the Head of Research and Development, Dr. Hashad. We have Vice President of Vision Care R&D, Bryan Reed.
We have Executive Director of Vision Care Clinical Development, Bill Reindel, James DiBella, and last but certainly not least, physician Mark Schaeffer, who is an optometrist in ocular diseases and contact lenses. If I ruined anybody's name from Joanne Wuensch, I say I'm sorry at this stage. I'm going to kick it off to you. There is a PowerPoint presentation. We can go through it. I have some questions. Should you have some questions, please email them to me. You know how to find me at joanne.wuensch@citi.com. We're just going to start to rock and roll. I pass it to you.
Joanne, thank you very much. We really appreciate the opportunity. First of all, I would like to apologize for my voice. I just catch cold, luckily enough, I am the least presenting today. My colleagues will do most of the presentation. I'm very happy just to also to be here to present some of our biggest innovations in the contact lens and the vision care area. Just holistically, if we look to the pipeline strategy that we have started, we actually executing on it in a very good way. It all started by investing in the four business areas: pharma, surgical, vision care, and consumer.
It also focusing on leveraging our internal capabilities, whether it's manufacturing plants or some research capabilities, then obviously investing in areas of a very high unmet medical needs, whether there's no treatments available or to be disruptive in the technology to reshape the therapeutic areas, and reshape the treatment paradigm in these areas. I'm very glad today that we are focusing on the vision care part, primarily the contact lenses. Again, as we are currently in the state of completing the geographic expansion of the SiHy and the silicone lens, which is an excellent platform, which also includes that we are now having all the modalities, the multifocal, the torics, and we are expanding in all the geographic areas that we are able to launch. We looked at other areas also for the SiHy platforms, actually, we came up that we need to have the full portfolio.
That's why we are investing in the premium FRP SiHy, which actually will be also providing unsurpassed lens comforts as it happened with the daily use. We also looked at some of the geographies that it was very difficult to start to launch the SiHy and found out that if we are able to do a cutting-edge new formulation that could have a better cost management there, we could actually be able to progress in a lot of geographies that really looking forward to have the SiHy technology available at certain countries and certain locations. Today, we are focusing on two of the most innovative technologies that we have in the contact lenses. One is the Project Halo. It's the first of its kind bioactive contact lens, and we will explain more what do we mean by bioactive contact lens.
Actually, the second is obviously on the myopia. As everybody knows, myopia is becoming a big healthcare problem, especially not only in the Asian countries, which is most prevalent, but also we started to see it in Europe and the U.S., primarily due to the use of devices and also because children, most of the time, are staying indoors, looking at screens, and so forth. The prevalence started to be very high and becoming really a big problem, and that's why we're looking. While there are some available treatments there, but we're looking to be the best-in-class in this category, and we're going to speak more about our technology and why do we believe that this could be disruptive in being the best-in-class.
Actually, I think in total, these pipeline products, if they come to the market, we should be expecting more than $1.2 billion total from these four assets that could be actually an additional for the revenue and continuous the growth of the revenue for Bausch + Lomb. I'm going to hand over to my colleague, Bryan, who's going to walk us through first the HA project or the Project Halo.
Thanks, Yehia. First, let me frame the opportunity. There are over 140 million contact lens wearers worldwide, yet 25% of those patients drop out of contact lenses in the first year. This is unacceptable and shows a gap between what patients expect and what current lenses are delivering. The key challenges the industry needs to solve are discomfort and dryness at an affordable price. The graph on the left shows a 2025 symptom tracker, and the results show that in the morning, only about 20% of patients report symptoms of dryness, but this steadily increases throughout the day to almost 70% in the evening. People come into contact lenses for appearance and lifestyle, but what determines whether they stay in lenses is that end-of-day comfort.
We are aiming to address that issue with an accessible new lens innovation that will both, number one help keep those 25% of patients into lenses, and number two, bring excitement to the category to help attract new wearers. We want to grow the pie, and we want to take a bigger slice of the pie. Next slide, please. Bausch + Lomb has been the innovator in contact lens materials. About every 28 years, we've introduced a disruptive innovation that has been a true inflection point in how lenses are made and worn. This started in 1971 with SofLens, the first mass-produced soft contact lens, and then again in 1999 with the introduction of PureVision, the first silicone hydrogel lens for extended wear. Now, 20 years later, we're doing it again a third time with Project Halo.
We're introducing the first bioactive category of contact lenses. Project Halo is the code name, and the lens is made out of a double dose of hyaluronic acid, or HA, both the structure of the lens and in the packaging solution. It's a fundamentally different approach to how we've made lenses to help solve that end-of-day comfort challenge. Now I'll turn it over to Jim, who will walk through the science behind this breakthrough material, its unique materials or properties, and what differentiates it from other contact lens materials.
Great. Thanks, Bryan. I'm really excited about the opportunity to talk about Project Halo today, not only because of the innovative science the team's delivering on, but because of what this project represents. It all started with a simple question. What's next after silicone hydrogels? As Bryan just said, the previous couple of decades of research have focused on putting silicone into lenses in order to improve oxygen permeability. With this one, we wanted to look beyond that and try to reimagine what else a lens could be. We explored ocular biology and adjacent biomaterials, and pretty quickly we landed on hyaluronic acid, or HA, as the natural starting point to build our next lens, especially given Bausch + Lomb's heritage and success with the Biotrue solution franchise.
The key breakthrough was once we figured out how to actually polymerize HA so that it becomes part of the backbone of the lens itself. What this does is create a fundamentally different structure compared to the lenses on the market today, and that's highlighted by the images on the right where you can see Halo. This is a cross-section of a lens and a zoomed-in picture of the polymer network. You can see Halo has a very unique structure compared to the conventional hydrogel and silicone hydrogel materials. What this structure does is allow for the differentiated material properties we're going to talk through next. As we go to the next slide, the big material property that was introduced at Investor Day is the bioactivity.
The HA that we're putting into this lens is retained with the lens until it's exposed to hyaluronidase, which is a naturally occurring enzyme in the tear. When that happens, the enzyme goes to work and starts releasing the HA from the lens for continuous hydration throughout the wearing cycle. In the graph, you can see the green line represents the enzymatic release of HA from the lens, and it's compared against the blue line, which is the amount of HA that you would expect to find in a natural tear. You can see the continuous hydration, and what we've tested out to so far is 19 hours, and we've seen HA release out through the 19 hours, we really need to expand our testing. The second material property is breathability. As we've already highlighted, historically, in order to improve oxygen permeability, you needed to include silicone.
As you look at this graph on the right, the bioactive lens, Halo, it compares favorably with the silicone hydrogels on the market on the right side of that graph. The key here is Halo has no silicone. These two data points really were the linchpins for the program that told us we were developing something completely new. As we go to the next slide, the next two material properties we want to talk about are what the patient will actually experience, and that's soft and smooth. The softness refers to the surface modulus. As highlighted by the green bar in the left graph, you can see Project Halo has a significantly softer surface than the conventional and leading silicone hydrogels that we've tested.
What this does is it cushions the interaction between the eyelid, lens, and eye. The smoothness, on the other hand, refers to the coefficient of friction. The easiest way to think about this one is you're going to blink about 13,000 times during a wearing cycle. Minimizing the interaction or friction between the lens and the eyelid is key for patient comfort. Together, these two, soft and smooth, represent more than just marketing claims. They're engineered features that we put into this lens designed around the patient wearing experience. If we go to the next slide, we didn't stop there. As Bryan said, we're also innovating in the packaging solution by introducing HA there as well. That way, as soon as the lens goes on eye, the HA can go to work protecting the ocular surface, creating a double dose approach.
When testing under drying conditions, we've shown that solutions with HA provide a protective effect for corneal and conjunctival cells. Highlighted by the graph on the left, you can see the metabolic activity is being measured for the health of the cells. The black bar represents a solution that has no HA, while the blue bar is our solution with HA. The higher the metabolic activity, the healthier the cells. When testing against oxidative stress, we see similar protective effects. These experiments are meant to represent real-world conditions, such as low humidity environments and screen exposure. All of this is really trying to highlight how we're redesigning this lens from the inside out with the user experience in mind. With that, I'm going to turn it over to Bill, who's going to tell you about how these material properties are translating to clinical performance.
Thanks, Jim. This slide covers the first external study in the clinical development process. As part of our developing of new lenses, we conduct various internal and external clinical studies. We have a research clinic here in Rochester, New York, where we conduct very small studies, but they're important in understanding the transfer of some of the laboratory studies that Jim talked about to see if they translate into clinical outcomes. Once we get feedback on those smaller scale studies, we iterate based on what we learn, and we go through a cycle of various clinical studies, which eventually lead us to a registration study. Our lab-measured advantages are beginning to translate to on-eye performance. As I mentioned, this is our first multi-site external performance study in the feasibility stage.
In this phase, we test, we learn, we iterate on both the material and the lens design. We work with our material researchers and our lens design individuals to improve on what we find in our first studies. In this feasibility stage of the clinical development, the multi-site external study showed strong early performance ratings. In this particular study, we had eight external investigational sites. It was a randomized bilateral masked design. Patients wore their lenses for 8 -1 6 hours per day over about a week. In this study, the investigators rated patient performance on each individual patient after a week of wear. Here you can see that the results were very promising.
With respect to the important wettability and smoothness of the surface that Jim talked about, because the patient is blinking over that lens over the course of the entire day, the eye care practitioners rated smoothness and wettable surface acceptable for 98.5% of the patients. Smoothness and wettability is also important in delivering clear vision. In terms of clear vision, the eye care practitioners rated the acceptability 98.5% on each individual patient. Overall satisfaction also was very acceptable for the individual patients. The acceptability was rated 86.9%. The results of these studies build confidence, and they really help us de-risk the next stage in development. The results show that what we see in the lab is translating to on-eye performance. For the first external study on a large scale with eight practitioners, these are very encouraging results.
If we go to the next slide, I wanted to talk a little bit about a study that we conducted within our Rochester clinic. Here, we wanted to understand the sustained hydration of the lens on eye over a 12-hour period. Now, this becomes very important. We know, as Jim explained, the characteristics of hyaluronic acid and its ability to hold water. What this study showed us was that this very high moisture retention continues over the course of that 12-hour wearing period. After 12 hours of wear, the Halo lens retained 99% of its moisture. Now, this compared to 94% for a conventional silicone hydrogel lens. Why is this important? Well, it's important because if a lens surface or lens material begins to dehydrate, it not only can change the comfort profile of the lens, but it also can change the vision profile of the lens.
As the lens dehydrates, the vision characteristics, the surface properties can change and result in kind of blurry, fluctuating vision. A 99% retention of moisture is very impressive. In fact, it's the highest we've seen in over 10 years of testing material characteristics in our research clinic. This really kind of supports that comfort story that Bryan talked about. It's tied to retention of moisture, and we intend that it will likely result in a better wearing experience as we look to grow the market, but we also look to reduce the potential for dropout. It really ties directly to some of the biggest drivers of dropout in contact lens wear. It really supports our value proposition as well, as we bring both practitioners and patients together to have a better wearing experience.
Now I turn it back to Bryan, who will discuss kind of transitioning innovation into the manufacturing.
Thanks, Bill. The challenge given by Brent was not just to invent a unique material, but to do so on our existing low-cost manufacturing platform. This approach minimizes the capital investment and also drives higher gross margins from day one. In order to accomplish this, we need a high-performing team. We're using our teams in both Rochester, New York, and Waterford, Ireland, to support this. We're using tools as well, like SVEM predictive modeling. SVEM stands for self-validating ensemble modeling, and it essentially layers machine learning with traditional DOE or design of experiments. As you can kind of see in the graph on the right, this allows us to balance multiple competing factors and optimize them, such as design, process, and material. The overall benefits are a faster development cycle and a more robust manufacturing process and supply chain.
Utilizing existing lines enables faster volume scaling for a more efficient global rollout across markets and modalities. Since we're not waiting for new lines to be built, it's ultimately a more capital-efficient path to market. Next slide, please. Right. Here's our key takeaways for the bioactive contact lens. Number one, the science is tracking. The material delivers a unique combination of bioactivity, breathability, softness, and low friction that directly targets end-of-day discomfort and dryness, the number one cause of patient dropout. It's also the first lens in this new bioactive category of lenses. Number two, we're taking a capital-efficient manufacturing approach by leveraging our existing low-cost manufacturing platform. It minimizes that upfront capital investment and drives higher gross margins from day one. Lastly, our timeline is intact. We have positive early clinical results that Bill highlighted before, and we're continuing to optimize the design and material.
We have our second external clinical study, multi-site clinical, on track for the second half of this year with launch in 2028. All right. Next slide. Now we're going to shift gears a little bit and talk about myopia control and the opportunity here. As Yehia mentioned earlier, myopia prevalence is significantly increasing globally and is expected to impact over 50% of the population by 2050. Specifically, among children and adolescents, it's been rising from 24% in 1990 to 36% in 2023, and is projected to impact over 740 million kids by 2050. What's causing this increase? Again, lifestyle shifts are the drivers. Yehia mentioned some of these earlier. Number one is kind of that near work, so increased screen time and close distance reading from tablets and phones. Number two is less outdoor time and exposure to sunlight and kind of distance viewing.
Number three, urbanization and more kids in urban environments. There's a lot less natural light and more time on screens. We are developing a differentiated myopia control contact lens to support early and effective intervention to address this growing pediatric need. Now Bill's going to walk through the science and why that early intervention is so important.
Thanks again, Bryan. Let's talk a little bit about the science of myopia progression and really why does intervention matter. It also hinges on axial elongation. You can see kind of on the central illustration here, myopia with the increase in axial length, the light rays come and focus in front of the retina. As a result, we can address that by prescribing, as eye care practitioners, spectacles or contact lenses. What happens in conventional lenses, what we've learned through studying the science, is that the correction will focus light on the back of the retina. Very sharp focus we see in that upper right-hand illustration. The peripheral rays focus light behind the retina, and the science indicates that that is a signal for myopia to continue progression. The ramifications of that are that it increases lifetime risk of serious eye diseases.
Unchecked, the progression can increase macular retinopathy, can have the potential for retinal detachment and glaucoma. That's why it's so important for us to hold myopia progression in check. Peripheral myopic defocus is really the scientific foundation for optical myopia control, where the peripheral myopic defocus signals the eye to slow axial elongation. In this bottom right-hand illustration, we are engineering this defocus to now be in front of the retina by adding a high amount of plus power in the periphery. In this illustration, you can see that the central rays continue to be focused on the back part of the retina. Now, with the higher amount of plus power, we pull those peripheral rays in front of the retina. This is the engineering that results in the foundational optical principles of slowing the progression of myopia.
It's founded on science, the mechanism is established, and our goal is to come up with a differentiated way of how we engineer a unique option for eye care practitioners and patients. If we go to the next slide, please. There are a variety of options available to practitioners and patients. We're going to focus on the optical interventions. In the world of optical interventions, the first soft myopic contact lens to control myopia was introduced in 2019. Since that time, there's been a convergence of science that really focuses on three basic principles. First of all, the higher peripheral plus power is important. Second, the larger pupil area coverage for the contact lens is important. Third, zone customization is very important. We'll talk about these a little bit. Our design mapped directly to those principles.
First of all, we're looking to have a stronger myopic defocus signal, more so than we see in traditional soft myopia control contact lenses. We're looking for a larger treatment zone across the pupil, we're also offering multiple zone diameters for the clinician to adjust the treatment mechanism. It's all science-led. It's not repurposed multifocal contact lens approach. It's evolving across the optical world based on science. Again, not a me-too multifocal repurpose. If we go to the next slide, please. Our investigational device is offered in two optical configurations, and you'll see illustrated here, we call one Z1 and the other Z2. What we're doing is balancing the vision for the myopia progression. You'll see in the center of the lens is the distance portion, the refractive portion of the lens.
In the Z1 lens on the left, you can see it's a little bit larger than the Z2 on the right-hand side. The circular surround is where the high plus power is located. If one moves to the illustration on the right, what's critically important is that whether the Z1 lens is fit or the Z2 lens is fit, is that the high plus power is consistent across the two configurations. Here you can see a Z1 line in blue and a Z2 line in green. What this references is where the light energy is concentrated for focusing light on the retina. You can see a cross-section of the eye, where you see the yellow rays continuing to focus on the retina, the fovea, and that's the principal image of focus ± 10 degrees from that focal point.
What drives the stop signal is the high amount of plus, which you can see in the 20–30-degree range on both sides, which on this illustration, you can see that those rays then are focusing light in front of the retina. Our optical modeling shows that both configurations preserve the intended myopic defocus mechanism. It supports an efficient regulatory manufacturing pathway because it represents one material with two different designs. That, in particular, makes it an easier path from a regulatory perspective, and it also is an easier path from a manufacturing pathway as well. It enables the clinicians then to direct the dose adjustment without having lots of complexity in fitting the contact lens. We can now move to the next slide, where Bryan will kind of summarize our efforts in the myopia control initiative.
Thanks, Bill. Let's take a look at the final lens. We are pairing our premium INFUSE One-Day daily disposable SiHy material, which has proven to be very successful in wearing experience, with our cutting-edge optical design. The optical design, which is the most important element of a myopia control contact lens, is differentiated from the competitors in three key areas. Number one is that high peripheral plus power. We have a unique power profile that provides that effective stop signal for the myopia progression. Number two, we have multiple zone diameter configurations, which allows for customization, as Bill just explained. Number three, we have dose adjustment across the SKU range, where we are adjusting the amount of myopia treatment based on the refractive prescription. For example, a -6 gets more treatment than a -1 patient.
Overall, it's designed for kids to balance controlling their myopia progression with their daily vision needs, and to deliver a healthy lens with exceptional comfort. Next slide, please. In summary, we're targeting a best-in-class myopia lens by combining that novel design with our premium material. That material supports both comfort and compliance, since it's important for kids to wear the lenses all day for high myopia efficacy. The daily disposable format supports a convenient wearing experience for kids and parents. Number two, the differentiated design allows for a customized approach, and it's made for kids. As Bill explained, it's backed by the latest science to support high myopia efficacy again. Lastly, the product's going to be supported by clinical data.
We have a U.S. registration clinical study that will kick off in the next couple of months, with additional studies planned in China and Japan to support the globe. Next slide. I think I'll kick it back to you here to wrap up.
Thank you.
Oh, boy. Sorry.
Thank you, Bryan and the team. I really want to conclude here by saying that we have a very robust pipeline for the contact lenses and the vision care. As you can see, beyond the SiHy platform, which has been very successful, and we are expanding in terms of geographies and modalities. We are actually going to sustain this growth and we're going to actually look at the bioactive contact lenses and the myopia contact lenses to be launching in the range of 2028 and 2029 consecutively. This will sustain the growth of the organization, and we do believe that they are addressing a huge unmet medical need, and as well as whether the myopia control also will be the best-in-class in its category. I'll end up here, Joanne, because I know there is a lot of questions.
Again, let's open up for the questions. I know that the team is here as well, so I'm going to direct the questions if we need to each person.
Perfect. Thank you so much. If anyone wants to ask a question, you can email it in to me at joanne.wuensch@citi.com, or I'm already seeing questions coming in on OpenExchange. We can take them in any direction. We're just going to jump in here. I want to talk a little bit first about Project Halo. When I think about the progression of contact lenses over time, I think you're right. As an industry, it's been sort of stuck in this, I've got a silicone hydrogel lens, and then you're like, and then what? What does it really take to bring Halo to market? What does the clinical trial look like that you're going to need, and how do you think about the regulatory pathway?
Let me start first, and then I also may defer to Bryan if he wants to add anything else. I think, first of all, we wanted to confirm that we actually been successful with the material, and I think the team have done a fantastic job, as explained, by having actually different formulations, and we ended up with one formulation that we were able to test, and this has been very successful. They also have conducted multiple internal studies to start to see if the lens can hold for a short period of time, the feel of getting out of the eye, inserting in the eye. We were very confident after we saw the results of the first [audio distortion] study or external study, the one that we present the data from it.
The path moving from here is obviously we need to have all the learnings from the first [audio distortion] study and apply it in a second [audio distortion] study that will be starting the second half of the year. Then we should be able, if all goes well with the second study, we start the registration study in 2027. Based on the 2027 results, we can do the submission and obviously also the claim data and get the approval in 2028. These are the important steps in terms of the clinical study for the Project Halo.
How many patients-
Right. Sorry.
I just want to make sure I know how many patients you're expecting that you're going to need to have in these studies.
I think for the [audio distortion] study, we are expecting a very similar number to the one we have so far.
Right.
For the registration study, this number should be, again, Bill, if you want to add what the registration study, how many patients we will include?
Yeah. It can vary depending on the desired outcomes and the claims we're looking for. It can be in the neighborhood of 130, but sometimes we can take it up higher depending on the specific characteristics that we want to feature with this particular new lens design, lens material.
When they come to market, are you going to come to market with a lens that is, and excuse me for using the word just because it's going to come out, just a sphere, or will you come to market with a sphere and a toric and a multifocal, or are those staggered over time?
No. I think the plan is to have all modalities with this platform. Obviously, we need to come first with the monofocal and start with all the work now being done there, but the plan that we will come with all modalities on this platform, including toric, including multifocal, and include all the others.
Okay. The second half of 2028 launch timeframe, is that a U.S. launch, or how do we think about international and geographic reach?
The specific date, 2028, is focusing on the U.S. launch. However, obviously once we get more closer, maybe after the second [audio distortion] study, we will start also to think about the other regions and other countries as well.
Great. One of the things that's happened in this industry, as you have introduced new materials or new modalities, there's a price premium that goes along with it. Should we assume that this comes to market with a price premium and maybe one similar to other new product introductions?
I know that the commercial team is working on a lot of pricing research and doing a lot of work there. I don't want to comment on this because obviously this is outside the R&D area.
Maybe I'll say a word on that, Joanne.
Thank you, Brent.
Look, I think because of the way we designed this lens to be manufactured on existing lines, this will be a high-margin lens from the get-go. That gives us a lot of flexibility. Our goal is to expand the market, and so we are running pricing studies in various geographies, but the goal here would be to make this a lens for everybody.
All right, that goes right into my next question. When you say make a lens for everybody, do you anticipate this cannibalizing the current silicone hydrogel market or your current silicone hydrogel sales?
I don't think that that would happen immediately. I think it will take a long time. There's still so much unmet need around the world and changing practice patterns and prescribing patterns. Mark Schaeffer should jump in. We do have a KOL on the line here as well. I don't see that as really an issue for us in cannibalization. I think this is more about expanding our market share and the market in general for contact lenses.
Mark-
I agree.
Do you want to have a comment?
Yeah, I'll agree. I think there's three areas and three buckets when we talk about new materials that this should really go for. One of those is obviously retention of patients. When you talk about contact lens dropout, we've seen so much advancement in contact lenses since 1999 with silicone hydrogels. We've also seen a change in how we live our world, that these lenses have kept up with the times. We're doing so at a flatter rate than I think we expected to do so. We still have 20% dropping out every single year, whether that's quietly or loudly in our own practices. We want to retain those patients that are at risk for dropout.
You also have recruitment for new patients who may be thinking that contact lenses are designed to be uncomfortable because, in the last 28 years, we've had one material advancement in the backbone of the lens. The third is the re-engagement. I think there's a lot of patients who have dropped out of lenses silently for whatever reason, who are looking for a new reason to get back. The Contact Lens Institute, which includes all four major manufacturers, have done research on this, 62% of the public either have no opinion or think that all contact lenses are exactly the same. I think that speaks to what we do as practitioners every day in explaining the difference, because there are a lot of silicone hydrogel lenses that all perform very differently based off of their characteristics and their features.
Having a new material and a new category allows for us to really elevate and talk about a brand-new lens and a brand-new material that might re-engage some of those patients who have lost desire for contact lenses because they just think they're not a candidate anymore.
Is this ultimately going to be a daily lens? I just want to make sure I understood that.
Yes.
Yes.
Yes. Okay.
It is a daily lens.
Would you therefore see people who are still wearing longer range or frequently replaced lenses moving down? Is this another impetus to get more people into a daily lens?
I don't think that would be our focus. Our focus would be exactly as Mark. We're not going to try to trade people out if they're happy with what they have. It's about bringing innovation into the category, creating energy into the category again, bringing people who Mark, I think appropriately said, who dropped out, come back to the category. People who are sitting on the fence because they've heard from their friends or family about end-of-day dryness, and now that can be solved, come into the category. It's really about, as I said before, expanding our market share, but also expanding the market.
I think to that point, patients ultimately think that it's their fault that their contact lenses are getting dry. They blame screens just like everybody else does. Having materials that are designed specifically to help with having hyaluronic acid onto the surface of the eye, whether that's in a solution or in the lens itself, helping to protect and helping to elevate that lens experience. Again, that changes that equation from, okay, maybe I'll stop wearing my lenses as much, in the reusable space , let me upgrade to a better wearing experience. I think that ultimately, yes, we want all of our patients. If you ask every eye care provider in the country, they're going to say, I want all of my patients in daily disposables. We know that's not economically feasible for every single patient.
For those on the fence that can, we want to put them in a lens that's going to elevate, especially end of day, where we have more activities and more screen time and more Zoom calls and more work that we're doing after hours that we need to account for in our day.
To the best of your knowledge, is anyone else working on a bioactive material or on a new material that'll graduate from the silicone hydrogel wave?
We are not aware of anybody working on the material piece of it. There could be some other competitors or companies trying to add HA to the contact lens solution. At least up to our knowledge, nobody is working on having a contact lens with the backbone is an HA. Bryan, do you want to comment also?
Yeah, just like you said. Yeah, I think we're the only ones that are really making the structure out of the lens, out of HA. We have IP that's protecting that space. IP is only part of that story as well, because there's certain knowhow that's required to incorporate the HA and develop and scale this up, and that's not something that's easy to replicate as well. Lastly, we're not really building just this one product here. We're really trying to build a material platform and the capability to develop future products in this bioactive category down the road.
Okay. Can we pause or double-click on the contact lens market, and what you're seeing in the market? Particularly any trends that you're seeing that you can address on this call. Specifically, are there trends that you've seen over the last period of time that made you want to develop this product outside of patients complaining about end-of-day dryness?
It goes to what we were saying earlier, that the industry has done a decent job of iterating innovation around the silicone hydrogel platform. No one has really tried to solve the end-of-day comfort and dropout. That 20%-25% of dropout has been pretty stable, as Mark suggested. That's a big leaky bucket for the industry and for the practitioners. Our goal here was to really try to close the bottom of the bucket.
Okay. More specifically, I apologize, I am getting this question a fair bit right now. Anything that you can say about the second quarter contact lens trends? I know that wasn't the goal of this call. I am getting that question.
Yeah.
Here we go with it.
This is an R&D-based call. I think the market is, I've used this word many times to describe it, typical. That's probably as far as we should go on that here.
Thank you. Allows me to ask the next question.
Joanne, can I go back to the trends? I do want to say.
Please do.
One thing. In our world, some of the things that I'm seeing is, and it's not just dryness, but it's also vision, and we kind of talked about it earlier. Patients want to see clearly from 4:30 A.M. when they're doing CrossFit and gym and doing all that, all the way till their kids' activities at 9:00, 10:00 o'clock. These days, it feels like we're over-scheduled and we're on screens and phones, and we need to be going, and we need to drive late at night, and we're going back and forth. A colleague of mine drove 1,700 mi in a week because they had softball tournaments in three different cities, and that's just what we do now. I think that we need materials that will keep up with the hydration of the lens that maintains that vision throughout. We're asking our lenses to do more.
Again, as Brent said, we've done a good job of keeping up so that it doesn't leak too hard. If we had PureVision original as our only option, as our most advanced option, I think our dropout numbers would probably be in the 50%-60% range. As much as I would love to think how great of a material it was, it's also 28 years old. I think vision is also such a key component, but it's underrated in the fact that the lens material makes the vision work. I think that that's the second reason patients drop out of lenses, is that the vision isn't there, and it's usually at the end of the day or towards the end of the evening or afternoon. That's another reason why hydration matters. That 5% is the difference between 20/20 vision and 20/30 vision.
That's as little as it takes for refraction to change, one or two steps in the wrong direction, now I can't see clearly, I have to make some sort of consideration or swap in order for me to get through my day. It just makes me not want to wear my contact lenses more, I default to glasses, now I'm frustrated.
I hear you. I think I could go on and on talking about this product, but I do want to make sure we get some questions in on presbyopia management. Sorry, myopia management. My age is presbyopia management. Myopia management for kids, and this market, I don't think anyone that I've spoken to or any physician has ever questioned the size, the opportunity, but the problem has been multifactorial in terms of the product at the right price point, with the education of the parent, and identifying the right kid. What makes this product check those boxes?
First, maybe Mark can just give an idea that what are some of the problems with children in particular that we are trying to address.
How much time is it not a parenting podcast here? Kids.
Problems with children? I don't know. I could go on, let's focus on this.
My wife is a child life specialist. If you don't know what that is, thank goodness you don't spend a lot of time in healthcare. She's taught me a lot about how to balance talking to parents, talking to kids, and helping to understand where they're at, both from a parent's perspective and a child's perspective. I think it's hard when you're talking about correcting vision because. The other thing that we're seeing is there's a lot more parental myopia, which leads genetically to child myopia. We're seeing more parents with nearsightedness that end up passing it on to their kids. That just happens with life. We really have to get in the mindset of these are our most sensitive times as a parent.
If you're sitting there and having that conversation about your child's vision is changing dramatically, and we have to do something. You have a child who's in the most sensitive time in their lives, and any parent will tell you something like a pair of clothes can be comfortable on Monday, but on Tuesday, it's absolutely the worst thing they've ever put on. You have to account for all of these things, whether it's vision, and it needs to be clear. Whether it's comfortable, whether it's easy to handle. All of these things matter. It's like Whac-A-Mole. With my kids, it's like one day it's this, the next day it's this. You have to check all of the boxes because you have to be able to correct those objections.
With this lens, it's designed for kids, but it also has leading technology when it comes to comfort and handling and different vision profiles so we can match the patient to the vision so they can get the best outcome. The parent is motivated, the child is motivated, and the doctor is motivated. You have to get all three aligned because if one of those is not, that's when the cracks happen. That's when we don't take care of our patients as well as we know that we can.
There are other.
And I think the-
Oh, I'm sorry. Go ahead.
I was just going to say, and I think such a feedback was very important for us when we were looking for the technology.
Yeah.
It's going to be differentiated both on the material and the optical design part. The material we're using, obviously the SiHy that we have a great experience, and it's very comfortable, and we have been used also with children. The second, on the optical design, it's really about having the ability to titrate according to the progression of the myopia, so as actually we can control the myopia in a much bigger way. The second is also the clarity of vision, central vision, and the higher power on the periphery that prevent the progression on the axial elongation. This is really why we think that this is going to be a differentiated, and hopefully that this translates also a completely differentiated outcome we will see from the clinical trial.
It's not just the identification of myopia in kids, but it's identification of a specific product for them. There was something you said when you talked about the regulatory pathway, that it is easier in regulatory pathway, the Z1 versus the Z2 approach. What did you mean by that?
I think, Bryan, you said this?
I think Bill said that, basically, it comes down to these are not really two distinct different designs. This is basically an overall design, and we have multiple configurations in that, so we can provide options to the doctor with this single product. It's almost like a low add and a high add and a multifocal where you might start somebody in a low add and move to a high add. We're giving similar options to doctors and patients in this case.
Excellent. A similar question that I asked on Halo, which is to reach a launch date in 2029, what are the steps that needs to happen?
For the myopia, I think we're starting with some of the registration studies. The only thing here that it takes longer time that the regulation requires us to do two to three years of studies, depending on the geography and the region. Some countries require three years because they need to demonstrate that we are holding the progression over three years time period. Some other could actually accept two years. That's why we are starting multiple studies in different region, Japan, China, and the U.S. The whole time is going to be in the registration study, which we're starting early second half of the year.
Okay. When we think about your whole portfolio, you've got the myopia management, the bioactive, the silicone hydrogel, which is sort of a new lens also. How do you think about formulating all of those in your offering? This is really a question for you, Dr. Schaeffer, also, which is: how do you think about spending your time on which one you're going to be prescribing?
The answer is yes, right? I think it's who's in my chair, and what are their lifestyle questions? What are we talking about? What are their hobbies? What do I know about each and every lens? Because a lens for a nine-year-old with emergent myopia is going to be very different than a 55-year-old who wants to wear contact lenses for the first time. Right? These are very different propositions for me as far as value going across the board.
My job is to ultimately make the best recommendation that I can for the patient, and that's having state-of-the-art technologies for me to sit back and say, this is why I'm choosing this lens. Whether I'm choosing Project Halo or a lens like that, or choosing a silicone hydrogel because the patient has told me, listen, I can't afford a daily disposable on the front end. Okay, well, let's get you something that we have a premium product at not necessarily a premium price. A child with myopia, let's talk about your options. Everything is customizable, and every patient is different.
It is the paradox that we live in, unfortunately, because Yehia said that we need hundreds and thousands of patients to prove that something works, but in the exam room, a patient doesn't care if it works for 3,000 other people if it doesn't work for them. We have to live in this N of one paradox where we need it to work, but that's where B&L's come in, is giving us that confidence that when we pull these lenses and reach for them, that we're confident in how the results work and confident in that experience in the exam lane and beyond.
Maybe this is a question for you, Bryan. I'm not sure how, or I'm not going to identify who on the Bausch + Lomb team should answer this question.
Sorry, the question on the.
Portfolio management.
Yeah. No, portfolio management, I can take this, actually. In terms of portfolio management, I think we look at these opportunities as not competing internally. These are complementary. Actually, the different teams are working. I'm speaking from an internal perspective. We utilize some of the functions that support the developments, in completely different settings, so as we can proceed with all the projects at the same time. Externally, obviously, they are working in different populations. Myopia is a completely different population than the one we are going to target with the HA lens. Even on a clinical trial perspective or all these type, I think they are not competing at all, but they are complementary. Again, I think we are executing very well when it comes to the milestones for each one of them.
Excellent. I think I could go on for some time, we are at the top of the hour. I am not sure which one of you wants to do closing remarks or thoughts.
I'm happy to do the closing remarks. I hope that this just was a good session on showing you our innovations in the vision care and the contact lenses. Obviously, we're going category by category in these teach-ins, and we are very glad to do this today on the contact lenses in particular, because we are enjoying in Bausch + Lomb that the vision care and the contact lenses is one of the most mature R&D organizations. We can do everything from ideation all the way up to post-approval support. As you can see here, actually, the team have done a fantastic job in moving from the ideation all the way to where we are right now in a very short period of time.
Again, we have now actually a very good sense of where we're going, and I think we have already two platforms that can be showing the success within coming couple of years, 2028, 2029. Lastly, I just want to thank you, Joanne, as well, for providing us with this opportunity and looking forward for more on other assets as well that we can present as well.
Well, it's my pleasure to host, but it's also really been completely fascinating for me. Bausch + Lomb team, thank you. Everyone who's listening, have an absolutely fabulous day, and we'll all talk soon. Thank you.
Thank you very much.
Thank you.
Appreciate it. Thank you.
Thank you.
Thank you.