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spk07: Good day and thank you for standing by. Welcome to the ClearSci Biomedical Quarter 2023 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Jenny Coben, ClearSight Investor Relations.
spk08: Good morning, 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, and about the company's future expectations, plans, 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 31st, 2022, 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 Levesque, our Chief Executive Officer, and Charlie Degnan, our Chief Financial Officer. After our formal remarks, we will open the call for your questions. I would now like to turn the call over to George.
spk05: Thank you, Jenny. We delivered a productive start to 2023 as we execute on our near-term plan to advance our lead asset, CLSAX, an investigational proprietary suspension of Excedinib for suprachoroidal injection. Excedinib is a highly potent tyrosine kinase inhibitor that achieves pan-VEGF blockade, directly inhibiting VEGF receptors 1, 2, and 3, with high potency and specificity. We believe this broad VEGF blockade may have advantages over existing therapies for retinal diseases by acting at a different level of the angiogenesis cascade. Suprachoroidal injection of our proprietary CLSAX suspension delivers Excedinib directly to the site of disease and has demonstrated signs of biological effect and the potential for extended duration of therapy in our Phase I-IIa OASIS clinical trial in wet AMD. Results from the OASIS trial and extension study were presented last month at the ARVO annual meeting by Dr. Dennis Marcus. The trial consisted of four cohorts with single escalating doses of CLSA-X administered to participants who were then followed for three months. All participants enrolled in OASIS were heavily anti-VEGF treatment experienced with active disease at screening, which was confirmed by an independent reading center. The three-month trial was followed by an additional three-month extension study in the higher dose cohorts for a total of six months follow-up for those OASIS participants who elected to continue. CLS-AX was administered by our proprietary SCS microinjector, demonstrated an excellent safety and tolerability profile at all doses and in all cohorts. There were no adverse effects, no dose-limiting toxicities, no sign of inflammation, and because we inject behind the retina, we didn't have any instances of vitreous floaters or dispersion of drug into the vitreous. We anticipated this favorable safety profile as exudative is a well-characterized small molecule with much less propensity for ocular inflammation as compared to the administration of biological agents or viral-based gene therapies. In terms of outcomes, the OASIS extension study demonstrated that two-thirds of wet AMD patients in the two higher-dose cohorts were able to go at least six months without additional treatment. Participants experienced a 77% to 85% reduction in treatment burden, as measured by the number of anti-VEGF treatments they received during the six months compared to the six-month period prior to entering the OASIS trial. We observed anatomic signs of biological effect and reported stable mean best corrected visual acuity, or BCVA, and stable mean central subfield thickness, or CST, in the extension study participants in the two higher-dosed cohorts. These promising results are supportive of the potential safety, potency, and pan-VEGF blockade effects of CLSAX delivered via our SCS microinjector into the supracoroidal space. We're excited to further explore the potential of CLSAX in ODYSSEY, our planned randomized double-mass, multi-centered Phase IIb clinical trial in participants with wet AMD. Our primary goals for ODYSSEY are to demonstrate improved duration and reduce treatment burden for the CLSAX arm while maintaining visual acuity. We expect that the results of this trial will provide the necessary data to properly inform the design of a Phase III program for CLSAX in wet AMD. We believe CLSAX has the potential to be a twice-a-year maintenance drug for wet AMD, which, if demonstrated, would compare favorably to on-label maintenance dosing for the currently approved anti-VEGF drugs. The census on-label is 12 times a year, ILEA 2 mg is 6 times a year, and Bovismo is up to 6 times per year. We believe the Odyssey trial is balanced to meet its objectives effectively and efficiently with top-line results expected in Q3 2024. The Odyssey trial will compare CLSAX against a current standard of care, ILEA, or a FlibberSeb. In essence, we are comparing CLSAX maintenance versus a FlibberSeb maintenance with a goal of demonstrating similar visual acuity outcomes with a lower treatment burden for the CLSAX arm. plan to enroll a total of 60 treatment-experienced patients with wet AMD. Patients will be randomized, or participants will be randomized two-to-one. Forty participants will receive CLS-AX administered by suprachoroidal injection via the ClearSide SCS microinjector, and 20 participants in the comparator arm will receive intravitreal aflibrocept. The trial will include participants diagnosed with wet AMD within 36 months of their screening visit and with a history of responding to anti-VEGF treatments for the disease. Participants will have reading center confirmation of persistent active disease. The primary outcome measures for this trial are the mean change in BCVA over 36 weeks, as well as the assessment of safety and tolerability of CLS-AX. The secondary outcome measures are treatment burden, as measured by total injections over trial duration, other changes in visual function and ocular anatomy, such as CST, and the need for supplemental treatment. Participants in both arms will receive three monthly loading doses of Aflibrisib at two milligrams. The second loading dose visit, defined as the baseline visit, participants in the CLSAX arm will also receive one milligram of CLSAX by suprachoroidal injection. Participants in the comparator arm will also receive a sham suprachoroidal injection to ensure masking of the trial. Participants in the CLSAX arm will then receive another CLSAX dose at week 24, unless they require supplemental treatment prior to that visit. Therefore, participants in the CLSAX arm will receive at least two doses of CLSAX during the trial, which will provide valuable multi-dose safety information for an end-of-Phase II meeting with the FDA and the design of a Phase III trial. In the comparator arm, participants will receive additional Aflivirseb injections every eight weeks until week 36, unless they require supplemental treatment prior to the scheduled every eight-week Aflivirseb dose. Disease activity assessments will be conducted in both arms at week 12 and then every four weeks through week 32. This will determine if there is a need for supplemental treatment based on the occurrence of any one of the following four criteria compared to baseline. BCVA reduction of greater than 10 letters, an increase in the central subfield thickness of greater than 100 microns, BCA reduction of greater than five letters, and an increase of CST of greater than 75 microns, or the presence of a new or worsening vision-threatening hemorrhage due to wet AMD. The detailed trial design slides are available on our website in the corporate presentation. We believe this trial design makes sense for two key reasons. First, we are enrolling treatment experience participants with a history of responding to standard anti-VEGF treatments. We believe this will minimize recruitment of anti-VEGF sub and non-responders and may provide a larger population of participants to facilitate our trial enrollment efforts. This trial is more closely aligned with the recent FDA draft guidance for WET-AMD drug development by utilizing Aflibirzeb as a preparator, BCVA as the primary outcome measure, and utilizing a 36-week duration. Together, this will help us most effectively and efficiently prepare for a phase three program in WET-AMD. Our clinical operations team has been working hard to get Odyssey up and running this quarter. I am pleased to announce today that the study will open for enrollment in the next few weeks, and we expect to enroll our first patient shortly thereafter. We are targeting a total of 30 U.S.-based clinical trial sites and expect top-line data from the trial in the third quarter of next year. Moving on to Zypyr. At ARVO, Dr. Peter Chang presented survey data regarding the use of our SCS microinjector from retina uveitis specialists who have completed at least 10 suprachoroidal injections of Zypyr. The findings from the survey of early adopters of Zypyr suggest suprachoroidal injection was easy to learn and patient improvements in vision and macular edema aligned with the findings in clinical registration trials. This broadening use of our suprachoroidal delivery platform is encouraging as multiple clinical trials advance both with us and our development and commercialization partners. Our US and Canadian commercial partner for Zypyr, Bausch & Lomb, continues to expand outreach with Zypyr product education and SES injection awareness and training to healthcare providers. A significant number of physicians have been trained to date in the proper use of our SES microinjector. Fauci has also filed for Zypure regulatory approval in Canada, so we're looking forward to market expansion and additional territory. Our Asia Pacific commercial partner for Zypure, Arctic Vision, is currently enrolling a confirmatory phase three trial in macular edema associated with uveitis, and has completed a phase 1 clinical trial for the treatment of diabetic macular edema. Data from the DME trial is expected to be made public in the near future. Let me now provide a brief update on our SCS microinjector partner programs. Last week, Regenexx Bio announced that they had completed enrollment in the expansion cohorts of phase 2 AV8 and altitude clinical trials. These trials are utilizing supercorrelant delivery of RGX314 in patients with wet AMD and diabetic retinopathy. Regenexx Bio expects to report additional interim trial data from both trials, including initial data from the most recent cohorts in the second half of 2023. Regenexx Bio also announced that IND sponsorship has now been transferred to AbbVie for continued clinical development of the two superchoroidal gene therapy clinical programs using ClearSight's SCS microinjector. AbbVie is a widely recognized global leader in eye care. In the future, RGX314 will be referred to as ABBV-RGX314. Our oncology partner, Aura Biosciences, is utilizing our SCS microinjector to deliver their viral-like drug conjugate, Belsar, for the treatment of choroidal melanoma. Based on promising data presented earlier this year, ORA announced final plans for its global phase three trial utilizing the superchloroidal lute of administration. They expect to begin dosing for the trial in the first half of this year. With that summary of our programs, I'll now turn the call over to our CFO, Charlie Degnan, for a financial update. Charlie?
spk03: Thanks, George, and good morning, everyone. Our financial results for the quarter were published earlier in our press release and are available on our website. Therefore, I will just provide a summary of our financial status. As George mentioned, we are making excellent progress in advancing CLSAX, and we continue to prudently manage our cash balances as we move forward with our programs. As of March 31, 2023, our cash and cash equivalents totaled approximately $41.4 million. Based on our current outlook, we expect to have sufficient resources to fund our planned operations into the second quarter of 2024. We fully intend to fund the Odyssey study, and we'll be exploring the best available options. On a financial housekeeping note, our current shelf registration is expiring, so we plan to file a new shelf registration statement in addition to our 10Q. In the coming months, we will be participating in several investor conferences, including the J&P Life Sciences Conference next week, and the Webb Bush PACRO Healthcare Conference in August. We look forward to these interactions, and we'll keep you updated on our progress. I will now turn the call back over to George for his closing remarks.
spk05: Thanks, Charlie. I'd like to wrap up with a few final comments. During the first quarter, we enhanced our scientific advisory board composed of industry-leading retinal physicians to obtain expert medical and scientific input for our clinical and preclinical research pipeline. Dr. Tom Chula now serves as the chair of our SAB, and we have also appointed two well-known retinal physicians as new members of our SAB, Drs. Arshad Kanani and Leila Vajevic. The entire Scientific Advisory Board has been instrumental in providing input into our Phase IIB clinical trial design, and we appreciate their ongoing guidance on all of our development programs. We look forward to the initiation of our Odyssey trial this quarter. We believe that the number of participants, the duration, and the outcome measures of the study will provide necessary clinical data to inform the CLSAX Phase III program design. As we continue advancing CLSAX, we are excited about the potential for a potent, well-tolerated tyrosine kinase inhibitor in the multibillion-dollar wet AMD market. While we are intently focused on advancing CLSAX, we've also been very active intellectually behind the scenes on our science and SCS deliveries. Our research team is experimenting with more advanced injection designs, as well as other small molecule candidates that can be delivered into the supracoroidal space to target a number of retinal diseases. In the ophthalmic medical community, there's increasing acceptance for treating serious retinal diseases through the delivery of therapeutics behind the visual field into the supracoroidal space. We believe this creates significant value for our proprietary SCS microinjector platform that provides a safe, in-office, repeatable, non-surgical procedure to reach the back of the eye. We are well positioned to evaluate new collaboration opportunities along with tracking progress by our current partners. Our industry continues to generate exciting advancements, and we're pleased to be a player in that development of promising new retinal therapies. We look forward to providing updates as we move forward. I would now like to ask the operator to open the call for questions.
spk07: Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.
spk01: Our first question comes from Serge Bellinger.
spk02: Hi, good morning. A couple questions. Good morning, Serge. Good morning. First one, Serge, I think in the past you've mentioned that the ODYSSEY trial was not powered for superiority or non-inferiority. So, how should we think about a successful outcome for this trial? And secondly, I think Looking back at the OASIS trial, I think in one of the cohorts there were some issues in how physicians were assessing the retreatment criteria. Just curious how you plan to minimize that as an issue for the Odyssey trial. Thank you.
spk05: Okay. Thanks for the question, Serge. On the first question, you're correct. This study is not powered to be a non-inferiority study or a superiority study per se. What we're doing is we're trying to, a successful trial for us would be to show a lower treatment burden, as I mentioned, by looking at the number of injections over the trial period with maintaining stable visual acuity. What we're doing here is we're really looking for means and percentages that give us an estimation of how we would go into phase three on a fixed dosing schedule. So we don't need to do this in phase two, and this is not that uncommon, is to go into phase two and not power it in such a way as to be a non-inferiority trial. What we're trying to do is basically find our best estimate of what the The fixed dosing schedule would be to go into a non-inferiority trial in phase three. So we're not doing it. We're setting up or gathering the data in order for us to properly design and power a phase three program in wet AMD. So this is what we're going to do in Odyssey is gain that estimation of what we need to do in order to design the proper phase three trial. Also, we're trying to gauge where we're going to end up in terms of the final FDA guidance on trial design and wet AMD. As you know, the FDA produced the draft guidance, and there's a comment period, I believe, that ends this month. And so we'll see where the final guidelines come out. So we're also being very cognizant of the possibility for some changes in that guideline. So You know, that's the way we set up our trial for us. If we can see a successful outcome would be for us, as I said, a lower treatment burden. And we would be very happy if we see the vast majority, if not all, of the patients going at least four or six months on their duration post the loading-in period versus a flibrocept being dosed every eight weeks. There was a second part to your question. I'm sorry, I've forgotten it now, so...
spk02: Oh, no problem. It was about the assessment for retreatment. Oh, right. I think there were some issues with the interpretation of that in ways such as .
spk05: Right. Yeah, we've taken a number of steps to try to decrease those variations from protocol. The protocol, we've enhanced the training. We've enhanced the onsite supervision. We have a computer program that directs the physicians as to what to do exactly. The measurements in office have been done in a more stringent way. So we've been very cognizant of some of those off-protocol rescues. And as you recall in the OAC's data, those off-protocol rescues, when they were assessed by the Independent Reading Center, most of them should not have been treated. So they should not have been rescued. So we've been very cognizant of that and set up a very rigid protocol to try to eliminate that. I'm not sure we can eliminate all of that, but we've done our best to try to minimize it, if not eliminate it.
spk01: Thank you.
spk07: Please stand by for our next questions.
spk01: Our next question comes from Annabelle Simimi of Stifle.
spk09: Hi. Thanks for taking my question.
spk05: Hi, Annabelle.
spk09: Good progress. How are you? Good. I had a couple questions. One is just going back to the phase two design as you're talking about having not designed it for superiority or non-imperiority. The FDA is not going to be looking at lower treatment burden as an actual endpoint in phase two, correct, or in phase three. That's never going to be one of their endpoints. It's always going to be BCVA safety and duration. So just I want to make sure we're clear that we know that the endpoints haven't necessarily changed as we go into phase three, but you're just looking right now at treatment burden.
spk05: We're looking at maintaining a stable visual acuity, and we're doing a treatment burden. And the reason for it, you're right about what the draft guidelines say. We understand that. He was very clear, the Dr. Chambers and the group were very clear in saying that treatment burden cannot be a primary endpoint. We understand that. But for our phase two trial, for our phase two trial, we're looking at treatment burden And we're looking at duration, as I said, to set up the best design possible to go into phase three with a fixed dosing schedule of CLSAX. And obviously going into phase three, unless the draft guidelines change with their final version, treatment burden would not be a primary endpoint in and of itself in a phase three trial. And the FDA has made that pretty clear. It's very clear they're focused on safety and it's very clear they're focused on vision. So, you know, we understand that. But this is more to give us the kind of information to see, you know, do we have a twice-a-year product here? Can we dose it in such a way in Phase 3 to give us the optimal chance of success in Phase 3, doing it according, you know, in a non-inferiority trial in Phase 3?
spk09: Okay. Got it. And just on the draft guidelines, I guess – What are some of the potential changes you might possibly be facing to these guidelines? I mean, are they contemplating potentially a different standard of care with the BISMO or is there something else that they're contemplating that or from what you understand is being, I guess, tossed around as different ideas of new guideline requirements?
spk05: I don't have any insight into what the FDA might be considering. This is their first shot across the bow. I expect that there'll be comments coming in from many corners of the industry to either seek clarification or suggest possible changes to this. I would think it's possible over time that they may add something like Bovismo as an acceptable product. or even, um, yeah, Bob Isbell in particular, um, makes, uh, find that acceptable as a comparator. Um, but I don't think, uh, the time they're, they're clear now that that's not their position that could change over the next year or two. But, uh, as far as what they plan, I think this is their plan. They're going to let the industry comment on it. And, uh, I'm not sure where it's going to come out. I think there are some things about the, the comparator arm, um, that were a little unclear to some of us in the industry and either require clarification or change, but we'll see, you know, we, we, we've had those conversations. We've had some conversations with the agency as I'm sure all the other companies have. And, um, we think we understand it well enough for at least the Odyssey trial, know what we need to do there.
spk09: Got it. And then if I could ask one last question, I know that, um, Odyssey is now going to include, um, treatment experience patients only, um, But I think I understand that you're going to try to minimize the subresponders. Can you just help us understand why you might want to minimize that population? And if you do have subresponders, are you going to be doing these different analyses within the trial to, I don't know, just separate them out or identify different responses based on their stages of disease?
spk05: Well, you know, what we're really trying, we're trying to get, based on the conversations we've had with our KOLs and our scientific advisory board, we're trying to get the largest, most relevant population to them that we can enroll them here. And if you remember the OASIS trial, they were treatment experienced, but they were heavily treatment experienced. These were people that were referred to as anti-VEGF addicts. They were being treated much more, you know, frequently than even the label indication for either for the anti-VEGFs that they were on. We're not looking for that group. We're looking for a group that has shown a positive response to anti-VEGFs, but is not in the category of they're needing like a Flibosev every four to six weeks instead of every eight weeks. We're not looking for the really difficult to control group. But we're not looking for patients that are naive either. So we're taking patients that have had some treatment response, some treatment history, and seeing what we can do when we compare ourselves to a Fliboseb. We're trying to keep a fairly homogenous group of patients. and not trying to get a lot of sub-responders, and then we have to go in and do a lot of analysis. We're just trying to take this big group that we think is the most relevant group, certainly in the opinion of our KOLs.
spk09: Okay, great. That makes sense. Thank you.
spk07: Thank you. Please stand by for our next question. Our next question comes from Jonathan Wolding of JMP.
spk06: Hi, this is Catherine of Oconee on for John. And we just have a question about what non-priority margins you want to hit in terms of BCVA? I know in Odyssey you guys said that it's not powered for non-priority, but what would be kind of the goals?
spk05: You mean in terms of – I'm not sure I quite understand the question.
spk06: As far as, I guess – Looking at the two groups? Yeah, between the ILEA arm and then your treatment arm would be kind of the margin that you guys would be looking for.
spk05: I think we'd have to be within about four letters, four or five letters, plus or minus. It's comparable. We're just looking for a comparable, stable, comparable BCVA. It's certainly going to have to be clinically acceptable, that's for sure. But I think between the two groups, as long as within a couple letters of the two groups, we'll be fine.
spk06: Great. I have one follow-up question to that. As far as the reduction in treatment burden versus longer duration, which do you feel is more meaningful of the two measures?
spk05: Well, I think they're related. You know, if I can have 80% of my CLSAX patients go six months, I've got a very clear treatment burden reduction. So I think the duration is related directly to treatment burden. I mean, if you look at that period of time, you know, you're going to get three, yeah, three Aflibrasep injections to one CLSAX injection. So that duration is, feeds directly into treatment burden reduction. It's more convenient for the patient, for the caregivers, and for on a reimbursement basis. So it's better all around. And there's many of us that are trying to have this extended duration of therapy. It's better all around for patients and for payers and for caregivers that you can maintain stable visual acuity and not have to be injected every four to eight weeks. So I think the two are directly related.
spk06: What would be kind of a meaningful result as far as the measure goes in terms of time and then in terms of the duration between treatments?
spk05: Right now we're looking at, you know, we're hoping that all of our patients go at least four and the vast majority go to six months in terms of duration. I mean, because if you look at what's now in the market, Boviasmo says, for example, it can be up to four months, but we know that over half their patients need to be retreated before three months. High-dose ileas being up for approval, and they're asking for approval between three and four months after quadrupling the dose. So we think there's a lot of room for improvement and improvement. An excitement by physicians, if we can be over four weeks, up to five and six weeks, really our target is trying to have a twice a year or every six months. Excuse me, I said weeks. We'll go four months to six months. Our target really, our hope is that we have a twice a year product.
spk07: Thank you so much. Thank you. Please stand by for our next question. Our next question comes from Andreas Arjorides of Whitbush.
spk04: Hi, George. Hey, George. Good morning, guys, and thanks for taking that question here. So just maybe a follow-up to some that have already been asked in a different way here. So thinking about or, you know, heading into Odyssey here, what is the bar for efficacy in terms of percentage of injection frequency reduction and percent of patients rescue-free? given kind of some of the data that you've seen with competitors. And then if you could provide updates on ongoing business development discussions regarding the use of the supracordial injector. Thanks.
spk05: Well, I think I was basically been answering that in some of the previous questions. We're hoping that a significant percentage of our patients in the Odyssey trial go five to six months after the injector. So, you know, without rescue. So we're looking for basically the lowest degree of rescue possible in the CLS-AX group. I mean, it's also possible even in the comparator group of the flibroceb that they're going to need treatment in between their every eight-week doses. So we're looking at that, and we think that we're going to get the vast majority of our patients go without need for supplemental therapy at least four, and hopefully the vast majority go five or six months. And so that's really all I can tell you. I don't, you know, other groups that have done this that had to have rescue, other groups that are studying, certainly the tyrosine kinase inhibitors have had patients that are enrolled in their study that arguably may not have required any treatment, which may make their data look a little bit better. We again are going Making sure that what we do when we enroll patients in our studies, like we did in OASIS and like we intend to do in Odyssey, is make sure that patients that are being enrolled have active disease. All of them need to have active disease so we know that patients require medicine. We do not want to enroll anybody in our trial, and we're trying very hard to prevent this, that may never need treatment over the trial duration period. I mean, there's a significant literature that supports people within that have been diagnosed but have inactive disease or they're completely dry on diagnosis may not require any treatment for six months. Just watchful waiting. So we want to eliminate that. We want to know if we have something that really works. And so we want to put our drug in patients that we know, for the best of our ability, will require treatment. And so hopefully in our arm, there's very few, if any, need for supplemental treatment. And the vast majority of the patients go forward to six months after receiving their initial dose of CLSAX. On the BD front, we continue to have active discussions with a number of companies that are interested in accessing the suprachoroidal technology that we have. We're the only technology that's been used in the clinic We've got six trials ongoing now around the world with several different partners, including our own trial. We have clinical trials in China. We have clinical trials here in the U.S. Aura is going to be doing their clinical trials here and overseas with our supercoital microinjector. And so, you know, people know we're clearly the leader in clinical administering drugs in the supracordial space. And people know that if they want to get there and they want to get there in a proven way, in a reliable way, in a safe way, they should be talking to us. And so we have those ongoing conversations, but we're not ready to announce anything on the partnering front at this time. Okay, great. Thanks for all the updates and we'll follow up later. Sure. Yeah, no problem.
spk07: Thank you. Please stand by for our next question.
spk01: Our next question comes from Yi Chen of HC Wainworth and Co. Yi? Yi, are you able to speak?
spk10: Hello, can you hear me?
spk07: Yes, hello, Yi.
spk10: Hi, sorry. Thank you for taking my question. My first question is, could you give us some additional color on this IPR launch, and how should we project the license revenue going forward?
spk05: All right, Yi, please repeat.
spk10: I was asking that could you give us some additional color commercial performance and how should we project the licensed revenue going forward?
spk05: Okay. Charlie, you want to take that question?
spk03: Sure. Yeah. So, from Zypyr, as we all know, Bausch & Lomb has launched that product. They've been very active. training more than a thousand retinal specialists in the U.S. to use Zypure. We've heard, had positive feedback, but Bausch has, you know, we're not allowed to step ahead of them and talk about their sales. And when they're ready to, they will report on it. So I can't give you any insight into Bausch's sales, B&L sales. And then from Bausch, Partnering estimates, we don't give out revenue forecasts, but there are some licensing milestones, nothing major coming up, I would assume, as some of our partners move into different phases in their clinical study. Sorry, but we don't give forecasts on our partners in milestones, regulatory milestones.
spk10: Thank you. My second question is, given the trial design of the Odyssey trial and your comments on treating naive patients, do you think in real-world practice, long-lasting, what AMD treatment will ever be used on treatment-naive patients?
spk05: On treatment-naive? I think with sufficient... That's why we're going to the group that we're going to first other than Treatment Naive. But I do think that eventually, as more data is obtained on ours and other products, I do think that more extended duration treatment will become more the norm. Obviously, physicians will work based on data. But as that data is accumulated, I think they will. there's a difference between saying they'll use extended duration and will they extend the duration of patient visits to the physician's office. I think that I can't really comment on what physician practices would be, but in our estimation, and I think in others estimation, it's not really going to change significantly the number of times per year a physician wants to see a patient. But I think it would, with extended duration, as it gets more, as more data is developed, I think it could make a small difference. For example, if patients with weight AMD are being seen monthly, they may go to being seen every other month. And then they may not need to be injected on every visit. But if they're being seen every month and demonstrating stable BCVA and the degree of fluid is holding reasonably stable, maybe they're injected every other visit. So they're being injected four times a year, but only seeing the doctor six times a year, but being injected three times a year or two times a year. So I do think it will eventually change the practice. In our conversations with KOLs, they're very excited about seeing durations longer than two months. You can see from the uptake of the BISMO right now where it has the opportunity to go to every four months, but not the guarantee because, again, like I said earlier, over half their patients needed to be retreated by three months. There's been a tremendous uptake in the BISMO with that small incremental gain. So I think if you were able to show that with very solid data, you can dose somebody and maintain stable visual acuity and keep the fluid in the retina under control for four to six months with solid data, I think that will change the treatment paradigm eventually in the physician's office. Thank you.
spk07: Thank you. I would now like to turn it back to Dr. Lozeski for closing remarks.
spk05: I want to thank everyone for joining us this morning on the call. We appreciate your continued interest in Clearside, and we look forward to updating you on our progress. Operator, you may now disconnect. Thank you.
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