Good day, and thank you for standing by. Welcome to the Clearside 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 the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one 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 Kobin, Clearside Investor Relations.
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 Lasezkay, our Chief Executive Officer, and Charles Deignan, 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.
Thank you, Jenny. We delivered a productive start to 2023 as we execute on our near-term plan to advance our lead asset, CLS-AX, an investigational proprietary suspension of axitinib for suprachoroidal injection. Axitinib 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 CLS-AX suspension delivers axitinib directly to the site of disease and has demonstrated signs of biological effect and the potential for extended duration of therapy in our phase 1/2a OASIS clinical trial in wet AMD. Results from the OASIS trial and extension study were presented last month at ARVO, at the ARVO annual meeting by Dr. Dennis Marcus.
The trial consisted of 4 cohorts with single escalating doses of CLS-AX 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 axitinib 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 therapy. 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%-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 CLS-AX delivered via our SCS Microinjector into the suprachoroidal space. We're excited to further explore the potential of CLS-AX in ODYSSEY, our planned randomized double-masked multicenter phase 2b clinical trial in participants with wet AMD. Our primary goals for ODYSSEY are to demonstrate improved duration and reduce treatment burden for the CLS-AX 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 3 program for CLS-AX in wet AMD. We believe CLS-AX 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. Lucentis on label is 12 times a year.
Eylea 2 milligrams is six times a year. Bevacizumab is up to six times per year. We believe the ODYSSEY trial is balanced to meet its objectives effectively and efficiently, with topline results expected in Q3 2024. The ODYSSEY trial will compare CLS-AX against the current standard of care, Eylea or aflibercept. In essence, we are comparing CLS-AX maintenance versus aflibercept maintenance with a goal of demonstrating similar visual acuity outcomes with a lower treatment burden for the CLS-AX arm. We plan to enroll a total of 60 treatment experienced patients with wet AMD. participants will be randomized 2 : 1. 40 participants will receive CLS-AX administered by suprachoroidal injection via the Clearside SCS Microinjector, and 20 participants in the comparator arm will receive intravitreal aflibercept.
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 aflibercept at 2 milligrams. At the second loading dose visit, defined as the baseline visit, participants in the CLS-AX arm will also receive 1 milligram of CLS-AX by suprachoroidal injection.
Participants in the comparator arm will also receive a sham suprachoroidal injection to ensure masking of the trial. Participants in the CLS-AX arm will then receive another CLS-AX dose at week 24, unless they require supplemental treatment prior to that visit. Therefore, participants in the CLS-AX arm will receive at least two doses of CLS-AX during the trial, which will provide valuable multi-dose safety information for an end of phase 2 meeting with the FDA and the design of a phase 3 trial. In the comparator arm, participants will receive additional aflibercept injections every eight weeks until week 36, unless they require supplemental treatment prior to the scheduled every eight-week aflibercept 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, BCVA 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-experienced 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 aflibercept as a comparator. BCVA is the primary outcome measure and utilizing a 36-week duration. Together, this will help us most effectively and efficiently prepare for a phase 3 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 XIPERE. At ARVO, Dr. Peter Chang presented survey data regarding the use of our SCS Microinjector from retina and uveitis specialists who have completed at least 10 suprachoroidal injections of XIPERE. The findings from the survey of early adopters of XIPERE suggest suprachoroidal injection was easy to learn, and patient improvements in vision and macular edema aligns 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 U.S. and Canadian commercial partner for XIPERE, Bausch + Lomb, continues to expand outreach with XIPERE product education and SCS injection awareness and training to healthcare providers. A significant number of physicians have been trained to date in the proper use of our SCS Microinjector.
Bausch has also filed for XIPERE regulatory approval in Canada, so we're looking forward to market expansion in that additional territory. Our Asia- Pacific commercial partner for XIPERE, Arctic Vision, is currently enrolling a confirmatory phase 3 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, REGENXBIO announced that they had completed enrollment in the expansion cohorts of phase 2 AAVIATE and ALTITUDE clinical trials. These trials are utilizing suprachoroidal delivery of RGX-314 in patients with wet AMD and diabetic retinopathy. REGENXBIO expects to report additional interim trial data from both trials, including initial data from the most recent cohorts in the second half of 2023.
REGENXBIO also announced that IND sponsorship has now been transferred to AbbVie for continued clinical development of the two suprachoroidal gene therapy clinical programs using Clearside's SCS Microinjector. AbbVie is a widely recognized global leader in eye care. In the future, RGX-314 will be referred to as ABBV-RGX-314. Our oncology partner, Aura Biosciences, is utilizing our SCS Microinjector to deliver their virus-like drug conjugate, bel-sar, for the treatment of choroidal melanoma. Based on promising data presented earlier this year, Aura announced final plans for its global phase 3 trial utilizing the suprachoroidal route 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, Charles Deignan, for a financial update. Charlie?
Thanks, George. 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 CLS-AX, and we continue to prudently manage our cash balance 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 Form 10-Q.
In the coming months, we will be participating in several investor conferences, including the JMP Securities Life Sciences Conference next week and the Wedbush PacGrow Healthcare Conference in August. We look forward to these interactions, we'll keep you updated on our progress. I will now turn the call back over to George for his closing remarks.
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 Ciulla now serves as the chair of our SAB. We have also appointed two well-known retinal physicians as new members of our SAB, Doctors Arshad Khanani and Lejla Vajzovic. The entire Scientific Advisory Board has been instrumental in providing input into our phase 2b clinical trial design. 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 CLS-AX Phase 3 program design.
As we continue advancing CLS-AX, we are excited about the potential for a potent, well-tolerated tyrosine kinase inhibitor in the multibillion-dollar wet AMD market. We are intently focused on advancing CLS-AX, we've also been very active intellectually behind the scenes on our science and SCS delivery. Our research team is experimenting with more advanced injection designs, as well as other small molecule candidates that can be delivered into the suprachoroidal 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 suprachoroidal 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.
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 one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Serge Belanger of Needham.
Hi, good morning. couple questions for us.
Morning, Serge.
Good morning. First one, George, I think in the past you've mentioned that the ODYSSEY trial was not powered for superiority or non-inferiority. How should we think about a successful outcome for this trial? Secondly, I think looking back at the OASIS trial, I think in one of the cohorts, there were some issues in the how physicians were assessing the retreatment criteria. Just curious how you plan to minimize that as an issue for the ODYSSEY trial? Thank you.
Okay. Thanks for the question, Serge. On the first question, you're correct. With this study is not powered to be a non-inferiority study or a superiority study per se. 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 3 on a fixed dosing schedule. We don't need to do this in phase 2, this is not that uncommon, is to go into phase 2 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 fixed dosing schedule would be to go into a non-inferiority trial in phase 3. We're not doing it. We're setting up, we're gathering the data in order for us to properly design and power a phase 3 program in wet AMD. This is what we're gonna do in ODYSSEY, is gain that estimation of what we need to do in order to design the proper phase 3 trial. We're trying to gauge where we're gonna end up in terms of FDA, the final FDA guidance on trial design and wet AMD. As you know, the FDA produced a draft guidance, and there's a comment period, I believe that ends this month.
We'll see where the final, the final guidelines come out. We're also being very cognizant of the possibility for some changes in that guideline. 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. We would be very happy if we see the vast majority, if not all the patients, going at least four or six months on their duration post the loading in period versus aflibercept being dosed every eight weeks. There was a second part to your question. I'm sorry, I've forgotten it now.
Oh, no problem. It was about the assessment for retreatment.
Oh, right.
I think there were some issues with the interpretation of that in OASIS. Just curious how you.
Right.
Minimum.
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 on-site 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. We've been very cognizant of some of those off-protocol rescues. As you recall in the OASIS data, those off-protocol rescues when they were assessed by the independent reading center, most of them should not have been treated. They should not have been rescued. 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.
Thank you.
Please stand by for our next question. Our next question comes from Annabel Samimy of Stifel.
Hi. Thanks for taking my question.
Hi, Annabel.
Good morning. How are you?
Good.
I had a couple questions. One is, just going back to the phase 2 design as you're talking about having not designed it for superiority or non-inferiority. I guess the FDA was, is not gonna be looking at lower treatment burden as an actual endpoint in phase 2, correct? Or in phase 3. That's never gonna be one of their endpoints. It's always gonna be BCVA safety and duration. Just I wanna make sure we're clear that we know what the, that the endpoints haven't necessarily changed as we go into phase 3, but you're just looking right now at treatment burden.
We're looking at maintaining a stable visual acuity, and we're doing a treatment burden. The reason for it. You're right about what the draft guidelines say. You know, we understand that. He was very clear, Dr. Chambers and the group were very clear in saying that treatment burden cannot be a primary endpoint. We understand that. For our phase 2 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 3 with a fixed dosing schedule of CLS-AX. Obviously going into phase 3, unless the draft guidelines change with their final version, treatment burden would not be a primary endpoint in and of itself in the phase 3 trial, and the FDA's made that pretty clear. It's very clear they're focused on safety, and it's very clear they're focused on vision. You know.
We understand that. 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? Without doing it according, you know, in a non-inferiority trial in phase 3.
Okay, got it.
Yeah.
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 bevacizumab, 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?
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 bevacizumab as an acceptable or even, yeah, bevacizumab in particular, find that acceptable as a comparator. I don't think they're clear now that that's not their position. That could change over the next year or two. As far as what they plan, I think this is their plan. They're gonna let the industry comment on it, I'm not sure where it's gonna come out.
I think there are some things about the comparator arm that were a little unclear to some of us in the industry and either require clarification or change. We'll see. You know, we've had some conversations with the agency, as I'm sure all the other companies have, and we think we understand it well enough for at least the ODYSSEY trial, know what we need to do there.
Got it. If I could ask one last question. I know that ODYSSEY is now gonna include treatment-experienced patients only. But I think, I understand that you're going to try to minimize the sub-responders. Can you just help us understand why you might wanna minimize that population? And if you do have sub-responders, are you gonna be doing these different analyses within the trial to, I don't know, to separate them out or identify different responses, based on their stages of disease?
You know, 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 a largest, most relevant population to them that we can enroll them here. If you remember the OASIS trial, they were treatment experienced, 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 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 is not in the category of they're needing like aflibercept every four to six weeks instead of every eight weeks.
We're not looking for the really difficult to control patients, but we're not looking for patients that are naive either. We're taking patients that have had some treatment response, some treatment history, and seeing what we can do when we compare ourselves to aflibercept. We're trying to keep a fairly homogeneous group of patients, 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.
Okay. Great. That makes sense. Thank you.
Thank you. Please stand by for our next question. Our next question comes from Jonathan Wolleben of JMP.
Hi, this is Catherine O'Keeffe on for John. I just have a question about what non-inferiority margins you wanna hit in terms of BCVA ultimately. I know, I know in ODYSSEY you guys said that it's not powered for non-inferiority, but what would be kind of the goal?
You mean in terms of. I'm not sure I quite understand the question. What?
Just as far as, I guess, what.
Looking at the two groups?
Yeah, between the Eylea arm and then your treatment arm, what would be kind of the margin that you guys would be looking for?
I think we have to be within about four letters.
Okay.
Four or five letters ±. It's comparable. We're just looking for a comparable, stable, comparable BCVA. It's certainly gonna have to be clinically acceptable, that's for sure. I think between the two groups, as long as within a couple letters of the two groups, we'll be fine.
Great. I just have one follow-up question to that. As far as reduction in treatment burden versus longer duration, which do you feel is more meaningful of the two measures?
Well, I think they're related. you know, if I can, if I can have 80% of my CLS-AX patients go six months, I've got a very clear treatment burden reduction. I think the duration is related directly to treatment burden. I mean, if you look at that period of time, you know you're gonna get three aflibercept injections to one CLS-AX injection. That duration feeds directly into treatment burden reduction. It's more convenient for the patient, for the caregivers, for, you know, and for on a reimbursement basis. It's better all around, you know, and there's many of us that are trying to have this extende-- duration of therapy.
It's better all around for the, you know, for patients and for payers and for caregivers, that you can maintain stable visual acuity and not have to be injected, you know, every four to eight weeks. I think the two are directly related.
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?
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, 'cause if you look at what's now in the market, Vabysmo 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 Eylea is being up for approval, and they're asking for approval between three and four months after quadrupling the dose. We think there's a lot of room for improvement and 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 month. Excuse me, I said weeks. Every, we'll go four-six months. Our target, really, our hope is that we have a twice-a-year product.
Thank you so much.
Thank you. Please stand by for our next question. Our next question comes from Andreas Argyrides of Wedbush.
Hi, Andreas.
Good morning, guys, and thanks for taking our question here. Just maybe a follow-up to some that have already been asked, but in a different way here. Thinking about or, you know, heading into ODYSSEY here, what is the bar for efficacy in terms of percentage of injection frequency reduction and % of patients rescue-free, given kind of some of the data that you've seen with competitors? If you could provide updates on ongoing business development discussions regarding the use of the suprachoroidal injector. Thanks.
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 injection. You know, without rescue. 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 aflibercept that they're gonna need treatment in between their every eight-week doses. We're looking at that and we think that we're gonna 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. That's really all I can tell you. I don't.
You know, other groups that have done this have had rescue. Other groups that are studying, that 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 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, we know that patients require medicine. Right? We do not want to enroll anybody in our trial, 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 with N that have been diagnosed but have inactive disease or they're completely dry on diagnosis, may not require any treatment for six months and just watchful waiting. We wanna eliminate that. We wanna know if we have something that really works, we wanna put our drug in patients that we know, to the best of our ability, will require treatment. Hopefully in our arm, there's very few, if any, need for supplemental treatment, and that the vast majority of the patients go four to six months after receiving their initial dose of CLS-AX. 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 Biosciences is going to be doing their clinical trials here and overseas with our SCS Microinjector. You know, people know we're clearly the leader in administering drugs in the suprachoroidal space, and people know that if they wanna get there and they wanna get there in a proven way, in a reliable way, in a safe way, That should be talking to us. 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. We'll follow up later.
Sure. Yeah, no problem.
Thank you. Please stand by for our next question. Our next question comes from Yi Chen of H.C. Wainwright & Co. Yi? Yi, are you able to speak?
Hello, can you hear me?
Yes. Hello, Yi.
Hi. Sorry. Thank you for taking my question. My first question is, could you give us some additional color on the XIPERE launch, and how should we project the license revenue going forward?
All right, Yi, please repeat.
I was asking that, could you give us some additional color on the XIPERE commercial performance and, how should we project the license revenue going forward?
Okay. Charlie, you wanna take that question?
Sure, yeah. From XIPERE, you know, as we all know, Bausch + Lomb has launched that product. They've been very active, training more than 1,000 retinal specialists in the U.S. to use XIPERE. We've heard had positive feedback, Bausch has, you know, we're not allowed to step ahead of them and talk about their sales. When they're ready to, they will report on it. I can't give you any insight into Bausch's sales, P&L sales. Then from partnering estimates, we don't give out a revenue forecast, you know, but there are some, you know, 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 a forecast on our partners and milestones, regulatory milestones.
Thank you. My second question is, given the trial design of the ODYSSEY trial and your comments on treatment-naive patients, do you think in real world practice long-lasting wet AMD treatment will ever be used on treatment-naive patients?
On treatment- naive. I think with sufficient. It's why we're going to the group that we're going to first other than treatment- naive. I do think that in eventually, as more data is obtained on ours and other products, I do think that its 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. Now, 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. 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 wet 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.
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. 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 Vabysmo 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 Vabysmo with that small incremental gain.
I think if you were able to show that with very solid data, that 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.
Thank you. I would now like to turn it back to Dr. Lasezkay for closing remarks.
I wanna 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.