All right. Welcome, everyone. I'm Yigal Nochomovitz. I'm one of the biotech analysts here. I've been covering the ophthalmology space, among other therapeutic areas, for quite a long time. So I'm really pleased to have with me three distinguished members of the ophthalmology drug development world. So from LENZ Therapeutics, Eef Schimmelpennink, President and CEO.
Thank you.
Hope I said that right.
You did.
Okay. Todd Brady, CEO of Aldeyra and the new CEO of Opthea, OPT, Fred Guerard. Thank you so much.
Thank you.
All right. So a lot to talk about. Each of you have very interesting pipelines and products that are either close to the clinic or in late-stage clinical trials. So why don't we just go through and give a quick introduction, what the lead asset is in ophthalmology and where you are as far as your path to commercialization.
Sounds good. And thanks for inviting us. Always great to be here. Definitely better in Miami than in New York on Tuesday. At LENZ, we've developed a pharmaceutical eye drop that basically restores your near vision. So it reverses presbyopia on a daily basis. So think of this as an eye drop that you put in in the morning, and you can actually see your phone up close again, if you're like me. And most people over 45, you will develop presbyopia. It's a huge market. Everyone gets it. That's why it's $128 million TAM for us. Very late stage. We actually have a PDUFA date of August 8 last year or next year, sorry. So we've completed our phase three, read that out earlier in the year with stellar results.
Very good.
Eef, do you have any samples?
That's a very, very common question. It's a very, very long list. And the FDA keeps telling us that we're on the review. And if they ever catch us handing out samples, that's it, so it's a long answer to say no.
No one is looking. No one can hear this. I'm Todd Brady. I'm the President and CEO of Aldeyra Therapeutics. We are. I tell people an immunology company that happens to be in the eye. Our first product is called reproxalap. It's for dry eye disease. We also believe we've completed phase three testing for allergic conjunctivitis, which are two of the biggest markets in the front of the eye, aside from presbyopia. But we have a robust pipeline behind that. We're pan-eye. So we also work on the retina. We have two retina programs, one in an orphan disease called retinitis pigmentosa. We have a nascent program for dry AMD, hopefully starting next year. And we have systemic programs for liver inflammation, metabolism, atopic dermatitis, and a few other things ongoing as well.
Fred Guerard, CEO of Opthea. Opthea is developing a biologic for a first-in-class VEGF-C/D trap that is being developed as a combination play with anti-VEGF-As to deliver better vision outcomes for patients suffering from wet age-related macular degeneration. This is a very interesting technology simply because we are targeting the unexploited pathway, which is proven to be the main driver of the disease, using, again, a technology platform that has proven to be successful because it's very similar to what Regeneron did with Eylea, except we are binding to a different form of VEGF. Finally, the market has not progressed over the last 20 years since Lucentis has been launched.
None of the drugs on the market today are more efficacious than Lucentis on visual outcomes. We're very excited. We are now in the middle of our phase three program. The readouts took two large clinical trials, 1,000 patients each, and the readout is next year.
Okay, great. So although each of you are sort of in different, mainly non-overlapping areas except for your early program in AMD, you're improving on an existing option in the case of presbyopia, in the case of dry eye, where there are many options, in the case of wet AMD, where there are also a few options. So go through, and for each of you, just sort of explain the value proposition, for example, for LNZ 100. Why is it advanced? How is it advanced versus what was attempted before? What's the value proposition? So people can understand why your asset is interesting.
Absolutely. So I've yet to come across somebody that likes to wear reading glasses. So think of it as this is an alternative to reading glasses. So you're no longer doing the on and off all day to see up close. But if you put your reading glasses on, you can't see in the distance. So that's how you should think about this eye drop. It's really a convenient way to bring your vision back to what it was before you were like 45, before you used to actually think about your vision. It was something that was just there. It was granted. You can see up close. So that's the value proposition. What you referred to, Yigal, is that AbbVie launched a product with the promise of what our product is actually doing a couple of years ago.
If you think about the MOAs, the simplest of MOAs that I've ever had to explain in any of the companies that I've been part of, basically what you want to do is get somebody's pupil to below two millimeters. It's been known for decades, if not centuries, that if you create a pinhole pupil, your near vision improves dramatically because you basically increase the depth of focus. So you want to get below two millimeters. That improves your near vision dramatically. Anything over two millimeters doesn't really do that. So the product that Vuity launched a couple of years ago, the smallest pupil that that product got to was about 2.3 millimeters. If you look at the clinical data, only one in four people saw a little bit of effect, and it was a very short lift.
Very different from what the target product profile and what our profile is and what people want. They want a once-a-day eye drop that, again, works for the full workday. So it needs to work rapidly and needs to work for the full workday. And that's what we've shown in our phase three study, which is a very large three-study program. We saw that within half an hour, which was the first time point that we've measured, we had 71% of patients hit at least a three-line gain of near vision.
That gets people back to 20/20, 20/32. And it lasted very long. At 10 hours, still 40% of people had that gain. The clinically relevant endpoint is actually a two-line gain. If you give people two lines of near vision improvement, they're able to go without their reading glasses. We had 95% of patients hit two lines at half an hour, still close to 70% at 10 hours, so truly a product that works for almost everyone, works very rapidly and for the full day.
All right.
In dry eye disease, there's no product that works fast today. Weeks, months, but not minutes. And that is our product. We have data not only showing that people look better in terms of reduced redness in minutes, but also they feel better in minutes. And I think that's a paradigm shift. Who wants to take an eye drop for weeks or months and then maybe have some marginal benefit? Instead, you'd rather take something and feel better in minutes. And the way we do that is we use dry eye chambers, which are small rooms where we torture patients by eliminating humidity and blowing air in their face. But it allows you to assess rapidly. And that's been the focus of our clinical development program.
So for us, there are drugs on the market today to treat wet AMD. And these drugs have been a complete revolution. Patients were 20 years ago given the diagnosis of wet AMD, and they were visually impaired or legally blind in a matter of weeks. And these drugs came. Lucentis was the first one and changed the market. Now patients get diagnosed and actually recover some vision. The remaining unmet medical need is that most patients, even in countries like the U.S., where patients are treated very well, do not go back to fully operating level of vision. So half of patients still cannot drive after even if they get these injections every four weeks. Half of them cannot go back into driving. And if you cannot drive, it means you cannot perform daily activities at home.
And wet AMD is a terrible disease because the disease starts by losing the center of your vision, which is what you use for any precise task. Recognizing people, reading, operating your house, you need the central vision. It's not like glaucoma where you lose the lateral vision first or the peripheral vision first. So this is what we are trying to solve here, is by giving patients when they're already in the chair and they were already getting their existing anti-VEGF-A, is to get on top, so they need to be receptive at every visit and gain better vision. We have phase 2b data showing that with a statistically significant superiority in visual outcomes at 32 weeks, showing that we can deliver up to a line or a bit more than a line of vision on average into these patients that are extremely hard to treat in wet AMD.
So that's why we think this approach is very sound.
So if you think about commercialization for your three markets, I guess I would characterize Eef and Todd sort of in the same conceptual bucket where the market is very big, 128 million. I don't think you referenced the number of dry eye, but it's a lot. And you don't need a large share to command a nice revenue picture. On the other hand, for anti-VEGF, I think the numbers are the share of patients on an anti-VEGF amongst the wet AMD; it's very, very high, if I'm not mistaken. So you have sort of opposite issues that you want to achieve that very, very high share to supplement the efficacy.
So as you think about commercialization, give us a sense as to how you would attempt to gain share where you don't need a lot of share, but even a small share is many hundred thousands, if not millions of patients.
No, absolutely. Great question. And given that we're within a year of going commercial regarding to the Q4 of next year, we're obviously very far advanced on our commercial strategy, which basically rests on three key pillars. One, we want doctors to recommend us. So that's the sales force. We want patients to request us by name. So that's a DTC effort. And I want to make sure that the journey to actually get the product is seamless.
So that's the sampling and then actually going to the retail or e-pharmacy to get the product. So hitting real briefly on those three, we'll have about a 100-person sales force that targets the doctors, really telling them about the product, having a high-frequency call cycle. If you think about those doctors, we just did a massive survey. We surveyed about 430 of our target doctors.
On average, they see about 350 patients on a monthly basis. 61% or 215 of them are presbyopic, so they're already seeing 215 patients a month. A 1% penetration on the target doctors that we're getting to equals to 30,000 new monthly scripts, so that's on its way to being a blockbuster with a half-decent refill rate, five packs a year, so with a 1% penetration, you can effectively show that this is a product that can get to that blockbuster status. To do $1 billion in revenue, you need about 5.6% of the current patients that they're seeing. That's before we're sending anyone in through DTC, and that's obviously that second pillar. This is going to be a self-pay, heavily branded product.
So we're putting everything in place to achieve just that, build that brand, get that patient recognition, send them in on top of the patients that, again, doctors are already seeing.
One follow-up there, Eef. When I speak with investors on it, given that it is largely a market that will be served by the opticians and the ones that are providing eyewear, people aren't completely clear that you do need a prescription for this product and that you do need to have a retinal exam. So can you just explain that aspect of it, that it's not just an over-the-counter product?
Absolutely. Yeah. This is still a script. It's an FDA-regulated drug, not self-pay, but still a script. And we like that because that gets the optometrists and the ophthalmology community engaged. So you go into optometry, you're seen there as part of the 215 patients. And the doctor says, you know what, I've got something else. Here's a five-day sample. Try it. See if you like it. And again, like I said earlier, within 10, 15 minutes, you can decide whether you like it or not.
I can sort of promise you that you'll be able to see your phone up close. You can decide then, do you like it? Do you feel the script? Yes or no? The question that we sometimes get, and that's maybe what you were getting at, is, well, doesn't that conflict with what the optometrist is doing? He's actually selling glasses.
Most of the readers, at least $2 readers that I have, that I literally get a 10-pack sent to my door every two months through Amazon. So that's not the revenue that we're taking away from them. We're actually adding revenue. So patients are now coming in because it is a script. They need to come back every year to get that new script. On average, a patient is only seen normally about once every three years. So you're increasing that, which means more sitting fees, additional exams.
And then the very last quick point, that retinal exam is recommended. It's not required, but it's a good thing to have a retinal exam. It's also a moneymaker for optometrists. So they'll immediately try to get you onto what's a non-dilated eye exam, which is a $40 copay. Again, more patients means more exams, means more money into the practice.
Todd, you just got the acceptance of the resubmission. You're on the final stretch. Tell us about your commercialization plan.
We have nine people in our company. So exactly 11% of our company is on this stage right now. We have a partnership with AbbVie, who I think is the only large pharmaceutical company left in the front of the eye. AbbVie invented dry eye with Restasis and thrilled to be part of what they're up to. AbbVie owes us what amounts to $94 million on exercise of the option. They have 10 days after approval. Our PDUFA date is April the 2nd. If the drug is approved, there's an additional $100 million milestone. And then we have sort of a co-promotion relationship where the P&L is split 60/40 AbbVie/Aldeyra. So our approach is a little different, which is we intend to support AbbVie. I think the point you make about optometry is interesting.
I mean, both of us are in markets that are becoming more and more optometry dominated. You don't have that problem yet, but I'll tell you it's coming, and I'm actually, from a patient standpoint, thrilled about that. Ophthalmologists make money with surgeries, and not everyone needs surgery. I see an optometrist, and so what that means for folks like Eef and me is that we need to have a broad reach, and the way we're doing it is, in theory, through AbbVie.
Just to follow up there, you mentioned dry eye. You mentioned AC. What's the thinking there in terms of how you're going to prosecute this marketing pitch? Do you need to talk about both? Because as we know, the Venn diagram there is nicely overlapping.
I was just going to say, you always sound smarter when you say Venn diagram.
It's a good word.
About half of the patients, there's a guy named Milton Hom who discovered this optometrist, actually. And he surveyed the patients that came into his office that talked about itching. Itching is what you get with allergy. As those of us that suffer from allergy, we claw our eyeballs out. And then he said, how many of you have dryness? And about half of them said they were dry. And then he did the same thing with dry patients. How many of you itch?
About half. So the Venn diagram is 50% overlap. There's no drug approved for both of those. So unless you want to take a steroid, which you can only take for a couple of weeks. So our proposition there is interesting from a dry eye standpoint. I think this is a differentiator for the dry eye market. There's simply no one-stop shop for both of those conditions today.
Okay. And Fred, you have an ophthalmologic challenge, but a different one, obviously, with several approved products. And there's continued innovation in the space. You're innovating, but you're not the only one. We've seen the bispecific approval with Vabysmo. We've seen the high-dose Eylea. We're seeing the TKI inserts. But tell us, what is your path? What is your approach to commercialization?
So we're in a very different situation because we are not competing with any of these drugs. We are going to be adding drugs. They are all anti-VEGFs in one way or form. The FDA accepted that fact. And therefore, that's why the clinical program we have, the phase three, is designed with one trial being done in comparison to Eylea, in combination with Eylea. The other one is done in combination with Lucentis because the FDA agreed, as well as EMA, that it's a class effect. These drugs are all non-inferior to Lucentis. So there has been no progress in quality of care over 20 years. The new ones last a bit longer. On average, in the U.S., seven to 10 days longer in terms of interval of injection. But this is certainly not.
And then now, when you add these seven, 10 days, the injections need to be given in the US market around every 55 days. So they are not even every eight-week drugs. So we're not competing with any of them, which will not be fun, knowing now Amgen entered that market a couple of weeks ago, launching a biosimilar of Eylea in the US. You have Genentech and Roche with Vabysmo. You have Regeneron with Eylea. That will not be a fun fight. The good thing is we are friends with everybody. We don't fight with anyone. The business model for us to launch is very different to my colleagues. It's a business-to-business model. Four retina networks in the US make 70% of the volume of injections in the whole country. So basically, we have four customers to convince.
Cencora acquired Retina Consultants of America a couple of weeks ago for $4.6 billion. So now it's all almost private equity-owned. They have purchasing departments, and you basically strike commercial contracts with them. And you get used this way. So it's a very elegant model. We believe we can launch in the U.S. having a team of tens of people, not hundreds of thousands of people. So very different business model.
And then just to follow up on that in terms of how you think about the practice dynamics. And of course, as we know and as we learned even yesterday from one of the experts, efficacy will rule the day. I mean, convenience is good, but efficacy is better. So how do you think about that? I mean, obviously, it's a second injection. Do you have plans for co-formulations? How are you thinking about that?
The way the drug is administered in the clinical trials that are ongoing is there are two injections given at the same time when the patients are in the chair and they get their anti-VEGF injections. We are monitoring the increase of intraocular pressure between the two injections, but we inject a 50 microliter injection for sozinibercept. And the anti-VEGFs are also 50 microliters. So the total volume we would inject at the same time would be 100 microliters. And that volume has been approved by the FDA for the geographic atrophy drugs. So we know already that our precedents, the volume is safe. We are indeed working. So that's the way it's going to be administered at launch. This is not disrupting the flow of the clinic because the patients are already in the chair.
Even if the intraocular pressure is being measured between the two injections, it doesn't take a very long time, and normally, you can inject the patients within a minute between the two injections. We are already working on a co-formulation to make it easier so that it's only one needle in the eye instead of two. And we are now in stability testing. It's actually quite complex because we are mixing two biologics in one vial. And the stability, obviously, is a real challenge, so we are already working on it. I want to say that with the fragmentation of the anti-VEGF-A market, where before we only had until recently branded products, so very few drugs were on the market, we now have a vast number of biosimilars that have launched or will launch in the years to come.
It may not be a commercial benefit to necessarily have a co-formulation in the U.S. market because there may be financial incentives for the clinics to use a certain biosimilar with which they have better commercial terms than using a co-formulation with us. So it's an option we want to provide, but it may not be the solution for all the patients.
What patients dislike are not necessarily the injections. They really dislike the visits. It's to have when you're 80, 90, or 100 years old to go every four weeks if you're on a very high frequency of injection. Some patients get even more frequently than every four weeks. You have to go find someone to drive you. You're normally visually impaired because anti-VEGF is in half of the cases to not restore your vision. You cannot drive there. You need someone to get there. It takes time to get your vision measured, to get your OCT done, to get the eye prepared, to get injected. Time-consuming when your independence is limited. The real burden is the visit. It's not the injection itself.
That's a good point. If you want to talk a little bit more about your direct-to-consumer initiatives as well as how you're targeting eye care professionals, I mean, you're going to be using a lot of channels to get the message out. You can't speak to all the details on the label yet, but you're doing some market awareness in terms of getting people to understand that they even have presbyopia because they may not actually realize that it's a disease or condition. So maybe talk a little bit more about that. And you're leveraging social media and potentially some "influencers" eventually to do this.
Yeah, no. A lot of next question. One thing is for sure, we'll never use the word presbyopia towards patients or, as we call them, consumers. Nobody knows what that is. When I was asked for this company, and they were telling me presbyopia, I had to Google it. I was like, "Oh, that's what I have." So how you talk to them is about you talk about blurry vision or the things that they can no longer do.
There's a million different instances on a daily basis that make you realize that your near vision is no longer there. So that's how we'll approach the consumer with a true DTC campaign. So what that looks like in our mind is not what Vuity did. Even though it was very effective, they doubled the amount of scripts when they turned on DTC.
Their version of that was putting commercials on the Hallmark Channel, which we feel is not your target population. That's not where the people that will buy this drug mostly live. It's also not very effective, so if you think about our DTC strategy, it's much more targeted, much more digital. We know where these people live on the TikToks and the Facebooks and the Instagrams, YouTubes. We'll obviously use, as you would do nowadays, the right influencers. Think about the big names that we're bringing in there, and Shawn here keeps asking me whether he can hire. No, he can't, so a lot of people that are higher on our list to bring in and get that word out. That's on the DTC consumer end.
What we're already doing now on the doctor end, and obviously, this is all unbranded because we're not approved yet, is we have our MSL team out starting to have those doctor-to-doctor interactions. We've also started an unbranded campaign earlier in the year, "I Am Selective" all spelled out in words, where we're talking about the importance of pupil size and being below 2 millimeters, that you can get the best with a pupil selective miotic. That's what these active ingredients are called. And then we're starting to highlight what some of the target populations are. It's one thing to have 128 million population out there that you can target.
That's very broad. So you want to bring people in. We want to focus them on what we initially see, three groups of early adopters. People have had refractive surgery, AKA LASIK. People are wearing contact lenses or people that go to a beauty spa. So think about your Botox users. Each of these groups alone is well over 100 million. So that's why we're targeting our campaigns.
Very good. I thought RFK was getting rid of DTC. Aren't you guys concerned about that?
Yeah. So if you can overcome the First Amendment, then that would be an issue or a potential. I think it's been tried before, and it's not something that we foresee happening soon, even if it goes in that direction. This is a self-pay product. This is not probably the first one that you would go after. I think you would target the Medicare-type products. But again, we don't see that going anywhere anytime soon.
It is an effective modality in dry eye too. We've all seen dry eye ads. It's used because it works. Be interesting to see how that evolves over the next four years.
Todd, maybe talk a little bit more because you said at the beginning, you're an immunology company with applications in the eye or something to that effect. So can you go back and talk a little bit more about aldehydes and aldehyde biology just at a high level and what you're doing beyond dry eye? You mentioned retinitis pigmentosa as well. So talk a little bit about that. I mean, I think we understand you've got a very good partner in AbbVie, so that box is checked.
Right. Right. We have a new target. We call it RASP, reactive aldehyde species, which is actually one of the few non-protein targets. It's very difficult to think of any drug that doesn't directly target a protein, a receptor, an enzyme, or something of that nature, and it's kind of interesting. I tell the KOLs we work with, Optometry, Ophthalmology, they're the first, well, should be the first physicians or healthcare providers anywhere to use this approach in humans on a commercial scale, so it's exciting.
I think proteins are great. We're good at targeting them. We need to move on and target other things, and so RASP are a family of small molecules, broad implications with immunology, but also metabolism. RASP are pre-fat. So maybe one day we could have a drug that reduces inflammation, makes you a little thinner, and reduces ocular redness at the same time.
And Fred, can you talk also a little more about MOA? And everyone's pretty familiar with the A and the B isoforms, but VEGF, C and D, how do you think about them in terms of driving the disease?
Yeah. So the disease is characterized by these abnormal blood vessels that grow in the back of the eye, and they start leaking. So you have this vascular permeability that is increased, and therefore, you have accumulation of fluid in the back of the eye. Think like a blister when you burn your finger. You have that on your retina. And of course, the longer the fluids stay there, the more likely the photoreceptors are going to die, and then the visual impairment becomes irreversible.
So this pathway, the vascular endothelial growth factor pathway, has been very well described for decades and as a main driver for that phenomenon of neovascularization and vascular permeability. The existing drugs on the market all target VEGF-A or VEGF-B or PlGF, basically everything that binds to the first and the second receptor of the VEGF pathway.
But they leave VEGF-C and D entirely free to bind also in the second receptor, but also in the third receptor of the pathway. So by combining anti-VEGF-A and C and D, you basically entirely block the stimulation of these three receptors and completely shut down the main driver of the disease. In animal models, it's actually really, really interesting. You see VEGF-C does everything VEGF-A does. It increases these abnormal blood vessels, increasing this opening of the walls of these blood vessels. Very interestingly, when you have AMD, you have a natural elevation of VEGF-A and C. And when you start treating the patient with anti-VEGF-A, you have a further upregulation of VEGF-C.
So the reason why some patients actually do not respond very well to anti-VEGF A or do not respond completely to anti-VEGF A or respond for a while, and then there is some sort of an escape mechanism at some stage, which you see in clinical trials, maybe because of this countermeasure elevation of VEGF C. So for us with sozinibercept, we trap C and D, remove them, and refrain them from stimulating the second and third receptors. And we should be able to better control the disease. That's what we saw in phase 2b.
We saw not only better visual acuity for the patients, but better resolution of the anatomy of the eye, reduction in the retinal thickness, reduction in presence of fluid in the retina, subretinally, the reduction of the choroidal neovascularization area in the back of the eye, as well as a reduction of the lesions in the back of the eye. So the totality of the anatomy of the eye was better with a combination drug as opposed to the traditional monotherapy.
You have a very extensive phase III program, the COAST and the ShORe, one with Eylea, one with Lucentis. So just a few follow-ups there. I mean, obviously, you did the phase II with Lucentis. You made the point that these are very similar. The basic VEGFs are very similar. Anti-VEGFs are very similar in how they behave. So just help us understand how you think about the outcomes here and also remind us when the data because they're coming pretty soon, right?
Right. So the first trial, the aflibercept comparator trial, will read out in the early Q2 of next year. The Lucentis one will be middle of next year. So it's really around the corner now. We indeed do not have data in wet AMD with aflibercept. We only have data with ranibizumab. Aflibercept was developed as a non-inferior product to ranibizumab.
So we have very good data from the VIEW 1 and VIEW 2 pivotal trials that Regeneron did 15 years ago, where they were comparing ranibizumab 0.5 milligram given every four weeks to aflibercept 2 milligram given every eight weeks or lower dose of aflibercept or aflibercept given more frequently. And so we have that data. So we know how these two drugs behave when you compare them head to head. And the comparison was that they were just non-inferior to each other. They were exactly the same.
And this has been proven again and again in real-world evidence data when very large trials were conducted comparing Avastin, Lucentis, and Eylea. And you could see that over a two-year period, there were maybe one injection difference over two years in terms of frequency. There was no difference in terms of visual outcomes. So we're very confident that the Lucentis data will translate into similar results with aflibercept.
Okay. And then one question I get, I don't get it as much these days, but I did get it early, is obviously with the phase II, you had a great result with the 2.0 milligram. With the 0.5, it didn't really differentiate much from just Lucentis. So I mean, the answer I've heard is, well, I mean, it's normal, right? I mean, you got to do dose exploration, and that wasn't a high enough dose. But I guess when some people see the picture, they just wonder a little bit. So maybe just help us understand that.
Yeah. So it was a dose-ranging trial. So the idea was to find the right dose. The 0.5 milligram was not statistically different from the Lucentis monotherapy. The combination with Lucentis and the 0.5 milligram was not different to Lucentis alone statistically on vision, but it was actually better on the anatomy. So the 0.5 milligram had some activity. You could see it on the resolution of the anatomical parameters, but it was probably not enough to drive better vision.
As you may know, there has never been a very strict correlation between one anatomical endpoint and visual acuity. That's why the FDA never accepted to move from BCVA as a primary endpoint in these trials to anatomical measurements, which would be a lot easier to do, a lot cheaper. But sadly, we have to go for functional endpoints in clinical trials. To answer your question, the two milligram is the dose, and that's the one we are moving with in the pivotal program.
Okay. And then just to wrap up, give us just a quick over the next three, four quarters, what are the key milestones? I mean, you mentioned the PDUFA day, but what other data sets or presentations at medical meetings or other milestones that we should be aware of from you as everyone anticipates the launch, which I assume would be late 3Q, early 4Q next year?
Yeah. No, so key things really focused on us getting ready for the launch. So obviously, on the regulatory side, we continue to have very productive discussions with the FDA. All working towards our August 8th PDUFA date on the manufacturing end. We already produced our clinical trial material at commercial level. So we'll continue to scale that up.
We're starting our standard production for commercialization in the Q2 . And then, as I've said, really having the MSL team out there currently talking to doctors, explaining what our product is, increasing on the unbranded campaigns, and then truly getting ready for launching this product in the Q4 , having a sales force ready to do so. So we're currently hiring the sales force. We'll have them ready by the middle of the year. And then Q4 is all about the launch.
Todd, quickly, your milestones?
April 2nd.
You're beating me to this.
How's that? Yeah, barely. Barely. April 2nd, so that's our PDUFA date for dry eye. Hopefully, we'll have an sNDA later next year. Behind that, it's skin, liver, and retina, so atopic dermatitis, metabolism, and dry AMD.
Awesome. All right. Good luck, everyone. Thank you.