Jenny Kobin - IR:.

George Lasezkay - CEO:.

Victor Chong - Chief Medical Officer:.

Charlie Deignan - CFO:.

Jon Wolleben - Citizens:.

Serge Belanger - Needham & Company:.

Debanjana Chatterjee - JonesTrading:.

Yi Chen - H.C. Wainwright:.

Daniil Gataulin - Chardan:.

Greetings, and welcome to the Clearside Biomedical Fourth Quarter 2024 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode and a question and answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to your host, Jenny Kobin of Investor Relations. Ma'am, the floor is yours..

Good afternoon, everyone, and thank you for joining us on the call today.

Before we begin, I would like to remind you that during today's call, we will be making certain forward-looking statements, various remarks that we make during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our annual Report on Form 10-K for the year ended December 31, 2024, and our other SEC filings available on our website.

In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change.

On today's call, we have George Lasezkay, our Chief Executive Officer, Dr. Victor Chong, our Chief Medical Officer and Head of Research and Development, and Charlie Deignan, our Chief Financial Officer. We also have accompanying slides that are available on Clearside's website in the Events and Presentations section.

After our formal remarks, we will open the call for your questions. I would now like to turn the call over to George..

Thank you, Jenny, and good afternoon, everyone. Clearside is the proven leader in the delivery of drugs and drug candidates to the suprachoroidal space. Our SCS Microinjector provides safe and reliable delivery with over 15,000 suprachoroidal injections performed to date.

We continue to have increasing interest among retinal specialists and leading pharmaceutical companies in applying our innovative delivery platform to treating serious retinal diseases.

We are pleased to announce that the positive results from our ODYSSEY Phase 2b wet AMD clinical trial led to a successful end of Phase 2 meeting with the FDA regarding the planned Phase 3 activities for CLS-AX.

Based on our interactions with the FDA, we are aligned on a pivotal Phase 3 program that we believe is positioned for success and maximizes the commercial potential for CLS-AX and wet AMD. Victor will elaborate on these plans shortly.

Our commercial and development partners have made excellent progress over the last several months as they continue to validate the broad applicability of suprachoroidal delivery in several indications.

Across our partners, suprachoroidal treatments being developed for delivery by our SCS Microinjector are now approved in two Asian territories under regulatory review in China and involved in two ongoing or planned Phase 3 trials.

Our partner, Arctic Vision, achieved several regulatory milestones in the Asia-Pacific region with ARCATUS, or XIPERE, for the treatment of Uveitic Macular Edema. This year, they announced that a new drug application is currently under regulatory review in China and that the product was approved in Australia and Singapore.

Importantly, Arctic Vision also entered into a commercial collaboration with Santen Pharmaceuticals for the marketing and distribution rights to ARCATUS in China.

In addition, REGENXBIO in collaboration with AbbVie announced in January that a global Phase 3 Clinical Program in diabetic retinopathy for their gene therapy candidate, RGX-314, now referred to as SURIVEC [ph], is planned to start later this year using our SCS Microinjector.

In addition, their Phase 2 ALTITUDE suprachoroidal trial is currently enrolling a cohort of patients with center-involved diabetic Macular Edema and their Phase 3 AVH suprachoroidal trial is enrolling a cohort in wet AMD at dose level four.

Our oncology partner, Aura Biosciences, is enrolling its global suprachoroidal Phase 3 trial of Bel-sar for the first-line treatment of patients with choroidal melanom delivered using our SCS Microinjector. Aura has also initiated a Phase 2 trial in Metastases to the Choroid.

And finally, our partner BioCryst recently highlighted plans to initiate clinical testing in 2025 of avoralstat, its plasma kallikrein inhibitor using suprachoroidal administration for the potential treatment of DME. With that, I would now like to turn over the call to our Chief Medical Officer and Head of Research and Development, Dr.

Victor Chong, to outline the Phase 3 plans for CLS-AX and other opportunities with our suprachoroidal pipeline.

Victor?.

Thank you, George, and good afternoon, everyone. As George described, we are excited about the result of ODYSSEY that supports CLS-AX as a Phase 3 ready asset for the treatment of wet AMD.

Today, I would like to share several slides outlining the Phase 3 plans that we believe will position CLS-AX as a leading maintenance treatment for wet AMD if the results are positive. To begin, I will highlight two subgroup analysis from ODYSSEY that helped inform the current Phase 3 trial design.

Some of these data were presented at Angiogenesis at Retina Society last month, which provide an opportunity for us to continue to gather KOL feedback. The first analysis provided the basis for the targeted patient population and supports enrolling treatment naive patients in Phase 3 trial.

On this graph, we showed the participant solely redosed the CLS-AX at week 24, meaning that they did not receive any additional interventional treatment before or after the second mandatory CLS-AX dose at week 24. As you can see, the subgroup analysis shows even more stable BCVA and CST in this participant to week 36.

And we believe that by targeting treatment naive patient in the Phase 3 trial, there may be an even greater percentage of patients reaching six months without the need for any intervention.

On the next slide, a second subgroup analysis support the plan to Phase 3 redesign that exclude the participant with non-disease related changes in visual acuity prior to randomization.

This chart exclude the data at which the visit where the patient vision have a change of 10 or more lesser from their previous visit, but did not have a corresponding change in CST of at least 25 microns. What they mean is that the patient did not see as well that day on the eye chart, but without significant OCT changes.

This tell us the BCVA change on that day may not be disease related. It may just be that the patient did not perform the test well on that day. In running this analysis, we again saw compelling BCVA result.

In the Phase 3 trial, by excluding patients who have a 10 letter change just prior to randomization, we may reduce BCVA variability unrelated to wet AMD activities. Now I'd like to walk you through the Phase 3 plans and trial design discussed and agreed with the FDA at our recent end of Phase 2 meeting.

The plan we presented to the FDA is for two pivotal non-inferiority trial. The trial design is similar to the most recent Phase 3 trial in wet AMD that lead to the approval of EYLEA high dose and VABYSMO. The design applies the redosing criteria generally utilized in real world clinical practice which will feature the ability to flexibly dose CLS-AX.

And we believe the ability to redose with CLS-AX versus rescuing patient with anti-VEGF product is an important differentiator compared to other TKI programs currently in development. Slide 9 shows the current plan that Phase 3 program designed to potentially reduce regulatory risk and maximize the commercial opportunity for CLS-AX in wet AMD.

I will walk through this key design aspect. As I mentioned previously, the plan is to enroll treatment naive patients which we believe can potentially expand the commercial value of CLS-AX with a broader patient population. From a statistical perspective, we know it is important to reduce variability in a non-inferiority study.

The plan is optimized outside the population. We know from previous studies, patients with poor vision and or thicker retinas have high variability in the outcome. Therefore, at screening, participants will be required to have a BCVA reading between 20/80 to 20 over 32. In addition, the CST reading on the OCT must be less than 500 microns.

These components are designed to minimize enrollment of highly variable patients to potentially increase the probability of success of the trial. Between the third and the fourth injection of Aflibercept, we do not normally see a change of vision or anatomy.

Therefore, the plan is to exclude participants who had more than a 10 letter change or a CST increase of more than 100 microns from their previous visit. This criteria were strongly recommended by KOLs on our Scientific Advisory Board and are designed to increase the probability of success by further reducing variability.

On day one, participants will then be randomized one-to-one to CLS-AX 1 milligram or Aflibercept 2 milligram. Participants in the Aflibercept arm will receive treatment every eight weeks per standard dosing label up to the primary endpoint at week 52.

In a CLS-AX arm, in week 12, 16, and 20, participants will undergo an assessment for disease activity to determine the personalized treatment interval or PTI. Based on the PTI, participants will be assigned to a treatment regimen of every 12, 16, or 20 weeks.

The plan is to employ in-office OCT biomarker that will be determined using an AI tool to improve consistency in assessing the need for re-dosing. For those patients who did not meet the criteria at week 20, they will be assigned to a treatment regimen of every 24 weeks.

Once a dosing interval is established for each participant during the PTI period, the participant will stay at that interval until the primary endpoint at week 52. This is the fixed dosing period. For example, if the participant met the PTI criteria at week 16, they will be given CLS-AX every 16 weeks in a fixed dosing period.

After the primary endpoint is reached, the trial will continue for another year as a safety follow-up period to produce the data required by the FDA for a new drug application. In a CLS-AX arm, the fixed dosing interval will end.

The participant will then continue and be treated with variable dosing according to anatomical sign based on the PTI criteria. In the Aflibercept arm, patient will cross over to receive CLS-AX every 16 weeks, which will provide additional safety and efficacy data in an anti-VEGF treatment experienced patient population.

It will also provide experience in moving patient from Aflibercept to CLS-AX as a maintenance therapy. Wet AMD is a chronic disease requiring numerous injections to maintain vision and stabilize the disease. We are targeting CLS-AX as a maintenance treatment, which accounts for the majority of the wet AMD treatment market.

We know from clinical experience that patients require differing frequency of treatment to achieve stable vision. We are the only TKI in development with multi-dosing data from our Phase 2b trial, and the only TKI in development with the ability to re-dose before six months.

Therefore, we expect minimal to no anti-VEGF rescue in Phase 3, which could reduce our regulatory risk and prove to be a clear and important differentiator. All in, we believe this important feature of the Phase 3 trial supports a strong regulatory and commercial strategy for the success of CLS-AX.

On Slide 17, we have laid out the competitive landscape related to dosing flexibility in the wet AMD market. The initially approved anti-VEGF drugs to treat wet AMD work well, but have lower durability and less flexibility in dosing regimen. The next generation have moderate durability and a more flexible dosing regimen.

We have heard from numerous physicians that the dosing flexibility of one to four months was important to them. In contrast, the protocol for other TKI currently in development only allow for dosing at 24 weeks’ interval, and participants will need to be rescued if they cannot go that long.

With durability up to six months and flexible dosing regimen, we believe CLS-AX will have a potential versatile and commercially appealing label and would be well-positioned to compete in the WET-AMD market, which represents over $12 billion in annual sales.

Before I turn the call to Charlie, I want to take a minute to review our pipeline opportunities. We continue to be excited about the broad potential of suprachoroidal delivery with SCS Microinjector.

Internally, I see a great potential opportunity beyond wet AMD, where delivering of small molecules via the suprachoroidal space could make a tremendous impact in the treatment of retinal disease.

Our research team is currently evaluating two approaches with certain specific small molecules for in-vivo models for the potential suprachoroidal treatment of geographic atrophy. Our team is doing the necessary work to potentially advancing one or both of these candidates toward an investigational new drug application.

In GA, we are currently evaluating two methods of action that could potentially be used as an add-on to complement-based therapy. Administered suprachoroidally, this small molecule suspension can treat both sides of the Bruch's membrane, including the retina, RPE, and the Choroid.

And with suprachoroidal administration of the agents, we expect to achieve higher concentration of drug in the Choroid. As a result, we believe this molecule will improve Choroidal perfusion to improve retinal function directly and slow progression. And modulating for the inflammatory cell can reduce the root cause of complement activation.

With that, I will turn the call over to our CFO, Charlie Deignan, to provide a financial update..

Thank you, Victor, and good afternoon, everyone. Our financial results for the fourth quarter and year-ended 2024 were published earlier in our press release and are available on our website. Therefore, I will just provide a summary of our financial status on today's call.

As of December 31st, 2024, our cash and cash equivalents totaled approximately $20 million. We believe we have sufficient resources to fund our planned operations into the fourth quarter of 2025. We are actively pursuing options to fund the CLS-AX Phase 3 program, including potentially partnering with one or more third parties.

We look forward to participating in the Needham Virtual Healthcare Conference and the JonesTrading Conference next month. I will now turn the call back to George for his closing remarks..

Thank you, Charlie. We remain focused on our small molecule suprachoroidal pipeline led by CLS-AX for the treatment of wet AMD. We have seen increasing interest among retinal specialists and leading pharmaceutical companies in applying the suprachoroidal delivery approach to treat serious retinal diseases.

Our broad formulation, development, and regulatory expertise in the delivery of agents to the suprachoroidal space makes us well positioned in the overall treatment landscape for retinal diseases.

We are grateful for the hard work and dedication of our Clearside team and the ongoing support from our stakeholders as we continue to advance our suprachoroidal delivery pipeline. I would now like to ask the operator to open the call up for questions..

[Operator Instructions] Our first question is coming from Jon Wolleben with Citizens. Your line is live..

Hey, good afternoon, and thanks for taking the questions.

The subpopulation and the amendments you're making to the planned Phase 3, I'm wondering if you could give any context about how you think that might improve the results from what you saw in Phase 2?.

Victor, are you there?.

Sure.

Can you hear me?.

Yes. I can..

Yes. So can you -- so I think that in the Planned Phase 3 that we tried to exclude the patient with higher rare disease. I think the one to think about is on the Phase 2, we're deliberately selecting the patients who are very difficult to treat, and we believe that moving to a more general population, we would have better results.

One of the subgroup analysis, the first one that we mentioned, said those who actually doesn't need any extra treatment, and so one of the concerns was that could be undertreated, but in fact they were not they were actually doing extremely well.

So we believe that when we move to the general population, that segment that only need every six months’ injection would be actually higher. I don't know whether that is what you are referring to, because the second subgroup analysis changed the population slightly in a different way..

It's sort of helpful. I'm wondering, you know, maybe it's a difficult question to answer, but maybe moving on to two other ones.

How long do you think it could take to enroll -- how long do you think it would take to enroll the treatment-naive population? And then last one for me, did FDA say you need a certain number of patients in each of these treatment intervals to have a sufficient size to show efficacy and safety? Or will it be purely on the individual assessment of the response as well?.

Yes, I think the first question first is how long do we expect it to enroll? And usually this kind of trial will be around 12 months or slightly under 12 months. And indeed that we see the recent trial in other Phase 3 doing pretty well. So we were expecting that would be probably just under 12 months.

In terms of the agency, that this is the type of analysis very, very similar to what the two recent approvals with EYLEA high dosing and faricimab. So we do not expect that they would be separating the adverse event rate in different group on different frequency. And it's really the drug as overall.

And it's just a similar expectation that we're using the drug when we get to market would be on different interval. So we'll not expect that. I think the agency was quite clear that it would be considered as one arm. So the whole event assessment will be merged together.

And I think that's a very similar modality that they use for EYLEA high dosing and VABYSMO..

Okay, got it. All right. Thanks for taking the questions..

Thank you. Our next question is coming from Serge Belanger with Needham. Your line is live..

Hi, good afternoon. I guess my first question now that the Phase 3 trial plan has been finalized, can you give us an estimate of the overall cost of such a program? And I guess, is it feasible, you know, we're talking about 900 patients total here for Clearside to run such a large program? Thanks..

So I'll answer the second part and let Charlie answer the first part. And yes, we would, using a global CRO. And so we believe that it's something that we would be able to manage. And although it's a relatively large trial, but at the same time that wet AMD trial is read to be straightforward from both the end point and the investigation meters.

And I'll let Charlie answer the first part about the cost..

Yes, and Serge, I'll also just remind you, you know, back, we ran two Phase 3 concurrent RVO studies years ago. So, you know, we know how to run Phase 3 trials here.

In terms of cost, you know, we're not giving specifics on the cost, but, you know, I think, you know, some of the other Phase 3s, I think I've seen, you know, they're around $55 million, $60 million for each study. But, you know, we haven't given out an estimate for our numbers -- for our trials..

Okay, thanks. And I guess one for Victor, I'm just curious, and as you set up the design of the Phase 3, whether you considered emulating one of your potential competitor in running a superiority trial? And why -- what were the pros and cons and why you decided to go forward with two non-inferiority studies? Thanks..

The two non-inferiority studies was true and tested, and the agency have reflected that multiple times. And this is a lot more risky if the two trials is not the same. And I can't comment on a competitor why they decided to do something different, and that is their decision.

And I think from our point of view and also our interaction with the agency, the two non-inferiority trials is proven and tested in virtually, if not every single retinal drug was approved based on the two non-inferiority trials, other than obviously the first one, Lucentis was a superior trial..

Thank you..

Thank you. Our next question is coming from Debanjana Chatterjee with JonesTrading. Your line is live..

Hi, thanks for taking my question. I was wondering if you could provide any additional color on the, you know, your financing strategies for the Phase 2 -- I'm sorry, Phase 3, and how should we think about the timeline of the study initiation? I know you were planning initiation in the second half.

Is that still the plan?.

Well, want me to take this?.

Yes, go ahead, Charlie. That's fine..

Yes, so we're still, in terms of the study, we're gearing up to continue to be ready to start the study in the second half of the year. Obviously, you know, we need to fund the clinical part of the study. You know, as we said, we're pursuing all our options to get the study funded, including potentially partnering with one or more third parties.

So that's about all the information I can give you at this point. As soon as we have some clarity, we'll let everybody know. That's all we can say right now..

Thanks for that. I have a quick follow-up.

So if I understood correctly, the sham in the study, is it being administered monthly? And I was just curious as to the design of why would you choose that instead of like every two weeks? Is that to kind of merge it with the PTI phase?.

So the way that we want to do the study is in every single visit, the patient will be given an assessment. And then after the assessment, then they will have a procedure. So that would be how that we agree with the agency of masking the study so that the patient will not know which arm they would be in.

So from a patient perspective, they will have an assessment, and then they will then have a procedure. And the procedure could be a suprachoroidal injection, could be a sham, and could be a Aflibercept injection. And again, that is depending on the PTI that I mentioned earlier, or if they have met the rescue criteria.

So throughout the study, that there will be a patient that has a Aflibercept injection. Sometimes it could be just in the beginning, only just in the beginning for the AX arm. And then the patient would have the injection in the Aflibercept arm.

So we have discussed that in detail with the agency, and the agency felt that would be an adequate masking or blind in the way that some other targeted areas use. So that's how we think that was the right thing to do. I'm not sure about the two weeks that you mentioned, but this is going to be done every month, every visit.

And other than some visits, there will be no procedure needed..

Okay. Thank you so much..

Thank you. Our next question is coming from Yi Chen with H.C. Wainwright. Your line is live..

Thank you for taking my questions.

My first question is, what are the potential factors that could contribute to a BCVA change over 10 letter, so the CST change?.

Yes. So what we have known in the clinic, in fact, that a lot of clinicians don't even believe the vision in the clinic, because it's just that it's such a high variability. BCVA is slightly more reliable. And in fact, at the agency also always talk about this 15 letter, it's only 15 letter is real.

And so I think that the understanding that, you know, a lot of our patients are pretty elderly, and then you could have in a bad day that they couldn't really see better that day or the test, they just couldn't deal with it. And that is something that we know in routine clinical practice.

In a clinical trial, there's some of these data points affecting our data. So what we have done in the support analysis that I show is that, you know, the OCT and last thing we have not changed at all. And normally that, you know, if your vision got worse, your OCT will get worse or vice versa.

And the 25 micron is just a kind of a way to think that, well, you have not given a 25-micron change, which is a very small change. And then your vision might not be reliable. And so we just think that this was the cohort analysis. So we took that out. But just that, not the whole patient, obviously, that would take out a lot of data points.

But just that one data point. And then as you can see on the chart, that make it, that result even better. Although all our research is already good anyway. But this is just making it even better, explaining that sometimes that some patients just don't do it well, you know, could be a problem. So translating to our Phase 3 design.

Now, obviously, we can't do this in a real study because it's a post analysis to understand. And what we decided that, you know, as I mentioned in the call, between the third and the fourth injections, and again, we have a lot of historic data that during those two visits, the vision doesn't change normally.

So again, if they did change, that means that that patient is unreliable patient. And so we believe that by removing those patients before randomization will help us to reducing the variability..

Okay, and by implementing these criteria before randomization, do you expect to have any negative impact on enrollment speed or future market adoption when the CLS-AX eventually reaches the market?.

Yes, so I don't think that it would affect the label in a meaningful way. And again, obviously, that is something that we can't really discuss in detail now. We have seen that in other approved products that they have particular inclusion exclusion criteria, but then the label is still the same as wet AMD [indiscernible] AMD.

We discussed with the agency and the agency didn't really raise any concern on the way that we want to do the study. And in fact, that, you know, I think that reducing variability to truly show whether drug work or not, you know, are scientifically justified.

So I think from that point of view, the label discussion is too early to talk about it, but we believe from past experience, that should not be a key problem. In terms of, you know, the recruitment and other things, you know, we actually did some analysis on a data set that I have access to during my academic time.

The number of patients that would get rejected, you know, between the third and the fourth injection should be less than 10%. And so it won't be a major impact, but we believe that 10% can create a lot of variability. And so by removing them would give us a better, more consistent result. And again, the agency agreed to that..

Okay. Thank you very much..

Our next question is coming from Andreas Argyrides with Oppenheimer. Your line is live..

Hi, thanks for taking our questions. This is Eka [ph] on for Andreas. Can you talk about the powering assumption in the Phase 3 trial? And also, if you would share, do you have any insights on how payers think about reimbursement for a potential three to six-month flexible dosing label for CLS-AX compared to competitors? Thank you..

So I go to second question first. You might be a little bit easier question, but I think the first question is probably quite technical. And the second part is like we have some payer research and the payer research have support our assessment, how that we can potentially put a commercial value to it.

And I think that a simplistic way to think about it is that some of our competitors would do something different to us potentially. So on the other hand, from our point of view, is we have a flexible dosing. So we believe that we're quite likely to model from the flexible dosing drugs such as idea high dose.

And then, you know, one way to think about it is that because we have a small molecule and the device is made by our own device. And so a cost of good would be very low and it would be actually lower than the biologic. So, again, that we can be potentially pricing it very competitively.

So I think that is something that for further down the road that we have explored on the payer research and what would be the best way to get into the market.

And then the first question is really a standard Phase 3, the kind of the assumption that we took some of the assumptions that are very similar to VABYSMO, we were changing to potential around a 14 letter variability. And we believe that our variability is probably a little bit lower.

However, that, you know, we were looking at a very similar to VABYSMO type of number. And we use the 4.5 letter margin as suggested by the agency. And then to get to the 90%, as you would expect on the Phase 3 study..

Thank you..

Thank you. Our next question is coming from Daniil Gatau with Chardan. Your line is live..

Hey, guys, thank you for taking the question. Victor, I have one for you.

Can you please elaborate on redosing criteria, which, as I understand, relies on OCT biomarkers and how these interplay with the rescue criteria of the BCVA loss and the fluid gain? And also, where does the physician's discretion come in in redosing decision? Because I think that's always a big variability factor. Thank you..

Yes, thank you for that question. And allow me to spend time to explain that. So, redosing and rescue is two different things in our position. So, redosing is similar to what we have seen with EYLEA high dose and VABYSMO. They have a certain criteria. And the two companies have different criteria. And I'm not going to go into detail of their criteria.

But, again, neither of those are really used in clinical practice. And we have spent quite a lot of time talking to a lot of KOL, including myself, that we consider that just the thickness is not really that reliable. And, in fact, that something what we call intraretinal fluid, means the fluid is actually inside the retina.

So, subretinal fluid, which is the fluid just underneath the retina, so not in the retina. And, again, over the years, we learned that intraretinal fluid, you know, the fluid that is inside the retina, they cause more damage, and as one would expect it, and also cause more visual loss.

And so, a subretinal fluid, in fact, is actually not as much harm and some debate that even some subretinal fluid is good for you. So, what we have decided is that because now that we can really map out not just the thickness, but we can actually map out the intraretinal fluid and subretinal fluid.

And then the exact criteria we have not openly shared yet, but we can share if that is, if we have intraretinal fluid returning, that would be used to redosing the patient earlier. And both subretinal fluid, we will allow a little bit more.

So, but that is similar to, as I mentioned, EYLEA high dose and VABYSMO, they, you know, have vision criteria, and they have so-called CST increased criteria. But we're just doing it a little bit more scientific, a little more technical. So, I think that is what we would plan to do, and that's what we're referring to.

And luckily that we now have AI tools that can do that. The second part about rescue is, again, just EYLEA high dose and VABYSMO, they were very, very rare that they have rescue. And in fact, that, you know, we have agreed with the agency, the criteria for rescue. And that is different.

That is something that, you know, the patients are losing vision, and as well as anatomy is getting worse. And again, this is something that we have agreed with the agency. That is very different, and even different probably in some of our competitive trials.

So, obviously, as you said, a physician can always so-called rescue a patient when they wanted to. We can't control that. And on the other hand, what we believe is similar to EYLEA high dose and VABYSMO, and in fact, if anything, our redosing criteria are tighter, in other words, easier.

And so we believe that, you know, because of that, we will have no rescue. Very similar to VABYSMO and EYLEA high dose. And again, obviously, that is what we believe. And we believe that that design is particularly useful. It's because that has been proven by other drugs already.

And so by doing that and by eliminating rescue, we believe that we can also reduce our regulatory risk and improve our possibility of success..

Operator:.

,:.

I want to thank everyone for joining us on the call this afternoon. We greatly appreciate your continued interest in our company, Clearside, and we look forward to updating you on our progress. Operator, you may now disconnect the call..

Thank you, sir. Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation..