Clearside Biomedical at The Citizens Conference: Strategic Trial Insights

On Wednesday, 07 May 2025, Clearside Biomedical (NASDAQ:CLSD) presented at The Citizens JMP Life Sciences Conference 2025. The company highlighted its innovative suprachoroidal space (SCS) drug delivery technology and upcoming Phase 3 trials for CLS-AX, a treatment for wet age-related macular degeneration (AMD). While showcasing the potential of extending treatment intervals, the company also addressed the financial challenges of funding these trials.

Key Takeaways

• Clearside’s SCS delivery technology is less invasive and reduces the risk of endophthalmitis compared to intravitreal injections.
• The Phase 3 trial for CLS-AX aims to extend treatment intervals for wet AMD to three to six months.
• Clearside’s partnerships with major companies like Bausch + Lomb and AbbVie REGENX are integral to its strategy.
• The company reported a cash balance of $20 million, funding operations into Q4 2025.
• Funding for the Phase 3 trials, projected at $55-60 million per study, is actively being sought.

Financial Results

• Clearside ended last year with a cash balance of approximately $20 million.
• This cash position supports the initiation of the Phase 3 trial and sustains operations into the fourth quarter of 2025.
• Each Phase 3 study is projected to cost between $55 million and $60 million.
• The company is exploring funding options to cover these costs.

Operational Updates

• Clearside’s SCS Microinjector has been utilized in over 15,000 injections, underscoring its established presence in ocular drug delivery.
• The company’s internal pipeline includes CLS-AX, ready for Phase 3 trials, and preclinical candidates targeting geographic atrophy.
• Partnerships with Bausch + Lomb, AbbVie REGENX, Aura, and BioCrysta leverage Clearside’s SCS technology across various indications.

Future Outlook

• The Phase 3 trial for CLS-AX will incorporate learnings from Phase 2, such as redosing strategies and adjusted screening criteria.
• The trial aims to better align with real-world clinical practice by using advanced imaging for personalized treatment intervals.
• Clearside anticipates that its flexible dosing model could differentiate it from competitors, potentially achieving a six-month regimen for over 50% of patients.

Q&A Highlights

• CFO Charlie Dignan emphasized the focus on delivering drugs through the suprachoroidal space, highlighting its advantages.
• CMO Victor Chong discussed the strategic decision to redose earlier in Phase 3, a move not mirrored by competitors.
• The agency’s support for an adjusting frequency model without rescue medication was noted as a positive regulatory indicator.

In conclusion, for a detailed analysis of Clearside Biomedical’s strategic plans and financial outlook, refer to the full transcript below.

Full transcript - The Citizens JMP Life Sciences Conference 2025:

John Walden, Senior Analyst, Citizens Life Sciences Conference: Welcome to day one of the Citizens Life Sciences Conference. My name is John Walden, senior analyst here. We’re pleased to have Clearside Biomedical represented by CMO Victor Chong and CFO Charlie Dignan. So thanks for joining us guys. Thank you.

Charlie Dignan, CFO, Clearside Biomedical: Great to be here.

John Walden, Senior Analyst, Citizens Life Sciences Conference: So, for those who may not be as familiar with the story, you talk to us about what you’re working on at Clearside?

Charlie Dignan, CFO, Clearside Biomedical: Yeah, I’ll just give a quick, overview. We’re focused on delivering drugs to the back of the eye through the suprachoroidal space. We’re the proven leader with this approach and have successfully navigated the drug and device regulatory pathway with the FDA. And our SCS Microinjector continues to provide safe, reliable delivery. We have now over 15,000 injections.

From a strategy approach, we’re focused on our internal pipeline and supporting our external collaborators. We have a small molecule pipeline. Victor will go into more detail on that I’m sure in chat. CLS AX is our phase three ready asset in wet AMD and we have, preclinical candidates for geographic atrophy. We’ve demonstrated flexibility of our suprachoroidal technology with established partners using our SES injector, microinjector, and we’re real pleased with the progress our partners are making.

B and L is commercializing XIPERE, our first product for uveitic macular edema. AbbVie REGENX is going into phase three in diabetic retinopathy with gene therapy. Aura is in phase three for choroidal melanoma and BioCrysta is getting ready to get into clinic for DME. So that’s kind of a quick overview. Can

John Walden, Senior Analyst, Citizens Life Sciences Conference: we talk a little bit about the suprachoroidal space just big picture wise? What are the potential advantages? Any drawbacks? We still hear some pushback from people not understanding why you do this and then also that physicians don’t like it. But it’s newer versus intravitreal injections, which everybody does all day every day.

So can you talk a little bit about the potential benefits and what you need to do to get more traction as Charlie mentioned there’s been thousands of injections done but there’s thousands of injections done daily for intravitreal. So can you talk a little bit about that dynamic?

Victor Chong, CMO, Clearside Biomedical: Yeah so I think that you know like was old enough to remember that doing intravitreal injection is a very big deal. I think that was the time that was the case and then obviously now it’s not a big deal. And I think the same thing with suprachoroid though that is slightly different and just for those who are not familiar with intravitreal is you can imagine the eyeball like a tennis ball, you go all the way in, you you you shut the whole thing in and then suprachoroidal is injecting that into the coat of the tennis ball or the coat of the eye. So you don’t go all the way in. By not going all the way in, one advantage is that going all the way in, that even you injecting a small amount of bugs into the into the eye, that bugs will allow to grow because you don’t expect bugs to be in the middle of the eye.

In the coat of the eye that is actually where the tissue is and then so we are under normal surveillance so just like that you know infection can easily get killed. So one of the key advantages is actually less invasive because we didn’t go all the way in and then without that the risk of what we call endopharmitis which is a terrible thing can happen to patient. So I think there are two important benefits over the procedure that we’re talking about intravitreal that you’ve done millions of times already. I think it’s just like really a culture change you know like just like that before intravitreal is an everyday thing it’s a big deal and then suprachoroidal is actually not a big deal at all. It’s a safer procedure, it’s less invasive, easier to a certain extent but it’s just something that you know if someone that would say that I’m a surgeon I would say that if someone say that it’s difficult either they are not a very good surgeon you know or that they have never done it before.

Anyone that would never done a procedure before obviously could find it challenging.

John Walden, Senior Analyst, Citizens Life Sciences Conference: I also think it’s interesting that each one of your partner Charlie mentioned have looked at the more traditional approach whether it’s subretinal for gene therapy in suprachoroidal or with Ora’s case intravitreal versus suprachoroidal have opted to go forward with suprachoroidal. So it’s showing that it has benefits that are manifesting in the clinical data.

Victor Chong, CMO, Clearside Biomedical: Right. So that’s an additional benefit that intravitreal the drug go everywhere in a way in a sense that it can induce more inflammation. And but going to suprachoroidal space is more contained and certainly for our pilot in choroidal rhemoma that they have tried intravitreal and then it doesn’t really able to focus on the tumor and then gene therapy has a similar problem that either you do very invasive to do some retinal surgery and then by intravitreal gene therapy also have some degree of inflammation. So I think that’s kind of like that there’s additional advantages, but again for our internal pipeline that we had a proven FDA approved product, we now have a phase three ready molecule. Those are in additional benefit over that individual approach.

Let’s focus on CLS AX. Tell us about that candidate and how it works, why

John Walden, Senior Analyst, Citizens Life Sciences Conference: is it different than what’s out there and how it fits into this broader class of drugs that are all coming in the late stage development.

Victor Chong, CMO, Clearside Biomedical: Yeah, so I think that you know we are focusing on the ocular anti VEGF area and I think one, you mentioned about AMD in specific is one of the biggest part of the market more close to $1,010,000,000,000 dollars. And most of the, currently all the tremors are biologic and biologic that, getting into the intravitreal space and then they kind of last, you know, potentially up to four months. I think there was always advertised that, but most physicians including myself would say that, well, you know, lucky to even get to three months, but again, that is something that we are the center of care and they only been, two of them only been approved quite recently so this is not really something that no recent approval and since some of them do extremely well, know, multi billion within one or two years. So what we would like to do is to extending that, you know, from say one to four months to more three to six months. And I think that sounds like a small in in incremental improvement.

It would be just like that, you know, when people think about moving from two months to one to four months, what was the big deal, but that always seems to be quite a big deal. So we think that is where the important is. So what we did differently is not instead of using a biologic, we’re using a TKI, a, you know, basically blocking the slightly different further further intracellular changes. And they’ve been effective and shown that also in the oncology world as well so we can understand that the biology makes sense and they are competitors, two other companies using a slightly different technology they’re using intravitreal and they need to put into an implant for the drug to release. But obviously because it’s something that you need to get into inside the eye, that make it difficult and they can’t kind of keep on putting more things inside the eye and so they decided to go for the every six months strategy but a fantastic thing from our point of view is that we are ballet biologic that you know we can just re dosing on our own drug in a different time frame and different period.

So we do know that patient needed different variability. We know that some patient will need to try every four weeks, some patient can go to twelve weeks and occasional sixteen weeks with the current standard of care. And so we chose that three to six months every twelve weeks to every twenty four weeks. I think that is a kind of schedule that most physicians also want to see the patient. So it’s really a perfect balance from our point of view that yes, patient, elderly patient might not want to come to the clinic every six weeks or so, but every three months is manageable.

But we believe that our drug can get most patients to the five to six months.

John Walden, Senior Analyst, Citizens Life Sciences Conference: And can you talk a little bit about your phase two data that you reported last year? What did you show? What makes you excited?

Victor Chong, CMO, Clearside Biomedical: Yeah, so in our phase two, we first try to do a proof of principle on those who have the very high need, almost the patient that more toward the four to four week lead patient. So on average, those patients had 10 injections over the preceding twelve months, so those are people that who need injection maybe every four to five weeks. And even in that population, we managed two thirds or so, get to six months without any additional therapy. And again, we maintained the vision, maintained the anatomy, I think that’s what we expected a drug would do. But I think most importantly for our phase two is we actually redose with our own drug already, so we tested that what we are going to redose with our own drug.

I think that’s a very critically important that we do move into phase three when you have never redosed your own drug. You don’t know what happened when you redosed your own drug. So we knew what happened and we do learn from that and then to design our phase three, our competitor that in their phase two or phase one they have never even redosed a drug and then they go straight to phase three. What did you see when you redosed and then what would be the theoretical risk with redosing for others? Yeah, I think the re dosing that we have found that in our study that if you are re dosing a bit late that in other words that you know physician always comment on the fact that you know some of the so called what we use are so called re dosing or rescue criteria are people that we don’t use in clinical practice and I think that we learned that when you’re actually getting to that stage that you actually need a so called rescue and then you redose at that time you know you might be taking a little bit longer for it to recover.

It was just like that in a patient that who had a problem if you leave it too late it might be actually more difficult to do so. So we adjusting on our phase three that we would be actually redosing a little bit earlier but again we believe that would be the right things to do and then our competitors not necessarily have that opportunity to do that.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Well it’s an interesting dynamic because we hear from some of the louder leading KOLs that the criteria of these trials are criminal that you know this isn’t how we treat anyway, we treat way earlier than we do in clinical trials and you guys are gaming the system. You know you’re showing what you’re showing in the trial but then in the real world you’d be treating earlier anyway correct?

Victor Chong, CMO, Clearside Biomedical: So I think that was what, you know I think to me as a clinical trial specialist you know I would say that phase two is taught learn how to do a phase three properly and I think that you know from our point of view that we learn that you know how that our phase three will be able to de risk. And again we are moving our phase three closer to the clinical practice and I think that a lot of KOL have told us about exactly what you just said and I say that what we were going to be a responsible company to actually do something closer to what the physician want to do in clinical practice and then we believe that our phase three data will provide even more information for physicians to use our drug in the future.

John Walden, Senior Analyst, Citizens Life Sciences Conference: And when we look back at your phase two data and data for the field and for what’s out there today there’s a lot of moving parts between you know rescue criteria, patient population, dosing. How do we go through all those nuances and try and figure out you know making heads or tails of what’s going on?

Victor Chong, CMO, Clearside Biomedical: Yeah so I think that you know from my perspective that comparing phase two with different population is always a little bit tricky. I think that you know we can think about that this simple variable or number one variable is that well they are free company with two different TKI and that’s the first thing that you can talk about. Ocular Therapeutic and us are using Acetinav as with the same TKI and again we believe that Acetinav is a better TKI because the IC50 is lower so I think that is more effective in kind of a more powerful TKI from that perspective. And then the question then would be whether it’s intravitreal or whether it’s suprachoroidal, I think we already mentioned that intravitreal is an implant something floating inside your eye, slightly bigger injection needle and you have other risks associated intravitreal implant and supravagoroid don’t have that problem and then also as I mentioned earlier that we can redose. And I think that the but then if you do look at the relative data you know that the data look quite similar despite the population are slightly different and again from our point of view we have the most active patient so called the worst patient and we can also have the most lenient criteria for redosing.

So in a way that you really want to say that, you know, that we are the easiest to need to redose and we are also the most active patient, So even if they are similar result, basically we’re better. Again, as I say that comparing core trial is always difficult, but at least that we are in the same ballpark. But I think the community sometimes misunderstood that when we want to do three to six months, they think that we don’t last as long as our competitor because they go for six months but in fact that was actually not true. In fact that we probably last as long if not even longer. However that we chose to have flexibility because physician life has ability and I think that is really why that we do that and we can do it.

Other people cannot have that flexibility.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Well we actually heard recently from a physician that they think Vabismo is doing so well because they have the every four week option and that payers are restricting high dose Alea for those more frequent patients. Do you think that’s a real paradigm? Do you think that that matters? And then also like are you losing anything on that early end too, earlier than three months? How do

Victor Chong, CMO, Clearside Biomedical: you think about how frequent is too frequent? Yeah, So I think absolutely true. I think that, know, like, I heard exactly the same thing with abysmal do really well because it won the four months and confirming that was true that Eylea Hido just went for the four weekly label, do another study. So again, know, from our perspective that you know if I were Roche I probably would like to do a four weekly study as well to give us a one to six month label. Although we don’t think we need it, I think that we are very confident even on the very kind of aggressive patient obviously aggressive, I don’t know why word, heavily active patient and we can still manage three months pretty for everyone.

Okay. So I think that might be something that, you know, and also that, you know, to move into a monthly dosing with no data whatsoever, I think that would be a risky approach. And and I think, you know, we could be something that, you know, when we done our three to six month dosing and again, if the time might come that a follow-up study could be a monthly dosing to our drug and we believe that our monthly dosing are completely doable with our drug but we just never had the data.

John Walden, Senior Analyst, Citizens Life Sciences Conference: And Victor you mentioned the big thing in phase two is learning for phase three so what are some of the learnings how are you designing your phase three to maximize their potential?

Victor Chong, CMO, Clearside Biomedical: Yeah. So I think the one thing we already mentioned about that, you know, we might want to redose a little bit earlier, you know, and also that it’s matching what the physician want that to be more real world data. So I think that’s good for both sides, one of the learning as well as what the physician want us to do. And then the second things that we learned is that we do notice that some patients that had a big visual acuity change with no anatomy change at all. And again, even the physician in the trial actually don’t think that was well AMD related.

But again, those are still data. So again, we were using looking at those data that that can really confusing a study. So we talked to a lot of KOL, a lot of discussion about those things and you say, particularly on a non inferiority study design, variability could cause a problem from a statistical standpoint. I think that, you know, we talked to the agency and the agency is quite happy that we justify, that we screen some of the patient out that who likely to have high variability. So for instance, that patient got poor vision, patient got a fair thick retina, patient that will have 10 letters swaying with no change, no real reason for that.

So we actually screened them all out before randomization. So again, the the agency was very was pleased with the way that we explained that why that we wanted to do that and they they completely accepting that that way of taking it forward.

John Walden, Senior Analyst, Citizens Life Sciences Conference: How did you look at that in phase two? Because remind me, I think you did one loading dose of Eylea before but you had a track record or you had records of peoples fluctuations historically. Is that how you monitored that group? So you said in phase two some patients had flexibility in the visual acuity without changes in the but you didn’t have the same loading dose schedule that you have in phase three, so how are you kind of?

Victor Chong, CMO, Clearside Biomedical: Yeah, so I think that you are right that this is changing that what we learn that patient have big variability.

John Walden, Senior Analyst, Citizens Life Sciences Conference: But they did it so early.

Victor Chong, CMO, Clearside Biomedical: Did in the study. So I think that is a translation of what that was the case in a So I think that’s very helpful to, the logic might need a step of adjustment.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Got it. Okay.

Victor Chong, CMO, Clearside Biomedical: So it’s something that we noticed that some patient can do that. Okay. And in fact that talking to KOL that in clinic they don’t even use vision to make any judgment call partly because patient can’t do that. And then I think that we pick up time point that we don’t expect a vision change and if they have vision change then we take them out.

John Walden, Senior Analyst, Citizens Life Sciences Conference: So can you talk about that screening period and the loading doses and you know when you’re ruling them out?

Victor Chong, CMO, Clearside Biomedical: Yeah so what we have decided to do is that you know when you got a very thick retina or very poor vision you would be well from the very beginning. Between the third and the fourth injection so in EYLEA standard treatment, you do monthly injection or free injection and then you then give eight weeks gap between that to the fourth injection. And during that third to four weeks in our historic data and I’ve been fortunate in the academic part that we have a look at 2,000 eyes and during that period you should not have any visual acuity change, certainly not meaningfully. So any patient that who have more than 10 letter change, more than that gain or loss because some people will say that well what happen if they increase 10 letter? The reality is actually increasing 10 letter during those three to four weeks that they should not true but they maybe just thought that they might have done something wrong as well.

So we believe that in a time point that we don’t expect a visual acuity change but they did have a visual acuity change and we take them out and we’re looking at our record that we’re taking out only about two to three percent but that two to three percent could be affecting the non inferiority margin.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Okay, that was my next question. And then talk about your personalized treatment interval and how you guys are determining when someone needs to be re dosed in phase three.

Victor Chong, CMO, Clearside Biomedical: Yeah, so that’s another aspect that we have able to incorporate the more advanced imaging technology that we have now today and so far that everyone that we’re looking at anatomy or just look at the whole overall thickness, but again it’s a condition that we know that when you got fluid inside the retina, we call intra retinal fluid, to dose that fluid actually under the retina because some retinal fluid they have different impact. To cut a long story short, intra retinal fluid is more serious because it’s inside the retina and we would decide that using the modern technology that if you got intraretinal fluid increase then you will be redosed and which is actually much closer to what I do and a lot of KOL do in the clinical practice.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Do you think that squeezes the effect size you saw in phase two then having a more stringent criteria?

Victor Chong, CMO, Clearside Biomedical: So I think that is really why we moved to a general population. So when we’re looking at the post, a very active patient, still a lot of injections are still active, that in the real world are probably five to ten percent of the population. But even that five to ten of the population, we’re still managing so well. I think that by moving to the general population, we believe that we can achieve a very similar percentage but again obviously that is something that

John Walden, Senior Analyst, Citizens Life Sciences Conference: need to off based And then can you talk, you guys have

Victor Chong, CMO, Clearside Biomedical: been mentioning this more as of late the difference between redosing and rescue? Yeah so rescue means that you use another drug. The agency really hated it because the whole idea is that you know if you’re doing a new drug it’s your drug. So if you really do rescue as in taking it from another drug then you know you can potentially not able to get approval. And in fact the agency had told us that if you have rescue requirement close to the primary endpoint, even a small percentage can lead to non approval.

And that is why we also chose the adjusting the frequency model, which the two drugs that was recently approved are also using adjusting the frequency and they wish we have no rescue in their phase three. So we believe that by adjusting the frequency and therefore that we will not expect any rescue and therefore that we are more secure to get approval. And giving patients what they need based on the biology. Do you have any idea how many patients you need added every six months regimen to get every six months included in a label? Is that written out?

It’s never been written out because I think that when you’re looking at furosemumab approval they got us four months they only got about 40 something percent so even not even half you know from that. So I think it’s something that we we don’t know. I think on label discussion, agency never formally talk about label discussion. Now, but I could ask I could argue that, you know, if you turn out to be 1%, then you probably question

John Walden, Senior Analyst, Citizens Life Sciences Conference: you wanna ask either.

Victor Chong, CMO, Clearside Biomedical: Right. But again, on the other hand that, you know, I think based on what we see that we will still expect 50% or more will get to six months.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Which is more than what they’ve shown and got it. Correct. Got it. And then maybe in the last minute, Charlie, if we could touch on, you know, cash where you guys are today, how are you thinking about, you know, the phase three starts and costs, and how do you get from here to phase three data?

Charlie Dignan, CFO, Clearside Biomedical: So we, we report earnings next week. So I could tell you our our cash at the end of last year was about $20,000,000. That allows us to have the resources to start up our phase three or plan for the phase three and and keep our base company going through into q four of this year. So we’re out looking to fund the phase threes. Typically based on Victor’s design and the size, we’re projecting around 55 to 60,000,000 per per study.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Anything like identical rinse and repeat trials? Yes. And then running in parallel?

Charlie Dignan, CFO, Clearside Biomedical: So slightly staggered. We’re trying to get them as close together.

John Walden, Senior Analyst, Citizens Life Sciences Conference: And just so you’d have to have unique sites or how does that work? Just, you know, one one one site can’t run both sites?

Victor Chong, CMO, Clearside Biomedical: No. Correct. Yeah. So so you could be at the same country, but it could there will be some country differences. Yeah but then within say The US that you will have some site doing say study A, study B but they will not be doing both.

Got it okay.

John Walden, Senior Analyst, Citizens Life Sciences Conference: Alright well it’s a very interesting time for the space I think you guys have a very compelling asset and story we’re looking forward to seeing the phase three kicks off And thanks again for coming and joining us today.

Charlie Dignan, CFO, Clearside Biomedical: Thanks for having us.

Victor Chong, CMO, Clearside Biomedical: Thank you. Thanks everybody.

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