Clearside Biomedical Q1 2023 Earnings Call Transcript

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Provided by Quartr
May 11, 2023

There are 7 speakers on the call.

Operator

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

Speaker 1

are in a

Operator

listen only mode. After the speaker presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker today, Ginny 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.

Operator

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 ks for the year ended December 31, 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 Begnan, our Chief Financial Officer.

Operator

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

Speaker 1

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, 23 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 A X 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 IIIa OASIS clinical trial in wet AMD. Results from the OASIS trial and extension study were presented last month at the ARVO Annual Meeting by Doctor.

Speaker 1

Dennis Marcus. The trial consisted of 4 cohorts with single escalating doses of CLSAX administered to participants who were then followed for 3 months. All participants enrolled in OASIS were heavily anti VEGF treatment experience with active disease of screening, which was confirmed by an independent reading center. The 3 month trial was followed by an additional 3 month extension study in the higher dose cohorts for a total of 6 months follow-up for those OASIS participants We 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.

Speaker 1

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 victories. 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 Participants experienced a 77% to 85% reduction in treatment burden as measured by the number of ANDAVEGF treatments they received during the 6 months compared to the 6 month period prior to entering the OASIS trial. Also, 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 and the extension study participants in the 2 higher dosed cohorts. These promising results are supportive of the potential safety, potency and PAMVEGF blockade effects of CLSAX delivered via our SCS microinjector into the suprachoroidal space.

Speaker 1

We're excited to further explore the potential of CLSAX in ODiSI, our planned randomized double mass Phase 2b clinical trial in participants with wet AMD. Our primary goals for Odysee are to demonstrate improved duration and reduce treatment burden for the CLS A X 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 A X in wet AMD. We believe CLS A X has the potential to The 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 6 times a year and bevizumab is up to 6 times per year.

Speaker 1

We believe the ODiSI trial is balanced to meet its objectives effectively and efficiently with top line results expected in Q3 2024. The ODiSI trial will compare CLSA X 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 A XR. We plan to enroll a total of 60 treatment experienced patients with wet AMD. Patients will be randomized participants will be randomized 2:1.

Speaker 1

40 participants will receive CLS ax Administered by suprachoroidal injection via the Clearside SCS micro injector and 20 participants in the comparator arm will receive intravitreal aflitercept. 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 treatment 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 A X. 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 3 monthly loading doses of vafliversted at 2 milligrams.

Speaker 1

At the 2nd loading dose visit defined as the baseline visit, participants in the CLS axon will also receive 1 milligram CLSAX by suprachoroidal injection. Participants in the comparator arm will also receive a sham suprachoroidal injection to ensure masking of the drug. Participants in the CLSA as CLSAX arm will then receive another CLSAX dose at week 24, unless they require supplemental treatment prior to that visit. Therefore, participants in the CLS A X arm will receive at least 2 doses of CLS A X 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 8 weeks until week 36, unless they require supplemental treatment prior to the scheduled every 8 week of Liberaceb dose.

Speaker 1

Disease activity assessments will be conducted In both arms at week 12 and then every 4 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, BCBA reduction of greater than 10 letters, An increase in the central subfield thickness of greater than 100 microns, DCA reduction of greater than 5 letters and an increase of CST of greater than 75 microns for 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 2 key reasons. First, we are enrolling treatment experienced participants with a history of responding to standard anti VEGF treatment. 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.

Speaker 1

2nd, this trial is more closely aligned with the recent FDA draft guidance for wet AMD drug development By utilizing aflibercept as a comparator, 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 3 program in wet AMD. Our clinical operations team has been working hard to get Odysee 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.

Speaker 1

S.-based clinical trial sites and expect top line data from the trial in Q3 of next year. Moving on to XIPERE. At ARVO, Doctor. Peter Chang presented survey data regarding the use of our SCS microinjector from retina uveitis specialists We have completed at least 10 suprachoroidal injections of XIPERE. The findings from the survey of early adopters of XIPERE suggest This broadening use of our suprachoroidal delivery platform is encouraging as multiple clinical trials advance both with us and our development and commercialization partners.

Speaker 1

Our U. S. And Canadian commercial partner for XIPERE, Bausch and 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. Pausch has also filed for XIPERE regulatory approval in Canada, so we're looking forward to market expansion in additional territory.

Speaker 1

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 AVIATE and ALTITUDE clinical trials. These trials are utilizing suprachoroidal delivery RGX-three fourteen in patients with wet AMD and diabetic retinopathy.

Speaker 1

REGENXBIO expects to report Additional interim trial data from both trials, including initial data from the most recent cohorts in the second half of twenty twenty three. REGENXBIO also announced that IND sponsorship has now been transferred to AbbVie for continued clinical development of the 2 RGX-three fourteen will be referred to as ABBB RGX-three fourteen. 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, Aura announced final plans for its global Phase 3 trial utilizing suprachoroidal lute of administration. They expect to begin dosing for the trial in the first half of this year.

Speaker 1

With that summary of our programs, I'll now turn the call over to our CFO, Charlie Deignan, for a financial update. Charlie?

Speaker 2

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 CLSAX 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 $41,400,000 Based on our current outlook, we expect to have sufficient resources to fund our planned operations into the Q2 of 2024.

Speaker 2

We fully intend to fund the Odysee 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 10 Q. In the coming months, we plan we will be participating in several investor conferences, including the JMP Life Sciences Conference next week and the Wedbush 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.

Speaker 1

Thanks, Charlie. I'd like to wrap up with a few final comments. During the Q1, 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. Doctor. Tom Ciulla now serves as the Chair of our SAB, And we have also appointed 2 well known retinal physicians as new members of our SAB, Doctors.

Speaker 1

Arshad Kanani and Leila Vazovic. The entire Scientific Advisory Board has been instrumental in providing input into our Phase 2b clinical trial design, and we appreciate their ongoing guidance on all of our development programs. We look forward to the initiation of our ODiSI 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.

Speaker 1

While we are intently focused on advancing CLSAX, 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 We're pleased to be a player in that development of promising new retinal therapies.

Speaker 1

We look forward to providing updates as we move forward. I would now like to ask the operator to open the call for questions.

Operator

Thank you. At this time, we will conduct a question and answer session. Our first question comes from Serge Belanger of Needham.

Speaker 3

Hi, good morning. Couple of questions.

Speaker 1

Good morning Serge.

Speaker 3

I guess, Good morning. First one, George, I think in the past you've mentioned that the ODiSI trial was not powered for Purity or non impurity, 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 the How physicians were assessing the retreatment criteria? Just curious how you plan to minimize that as an issue for the ODiSI trial? Thank you.

Speaker 1

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 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.

Speaker 1

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. So we don't need to do this in Phase And this is not that uncommon is to go into Phase II and not power it in such a way as to be a non inferiority trial. 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. 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 3 program in wet AMD, so this is what we're going to do in ODiSI It's gained that estimation of what we need to do in order to design the proper Phase 3 trial.

Speaker 1

Also, we're trying to gauge where we're going to end up terms of FDA, the final FDA guidance on trial design in wet AMD, as you know, the FDA produced a 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 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.

Speaker 1

And we would be very happy if We see the vast majority, if not all the patients going at least 4 to 6 months on their duration, post the loading in period Versus aflibercept being dosed every 8 weeks. There was a second part to your question. I'm sorry, I've forgotten it now.

Speaker 3

No problem. It was about the assessment for retreatment. I think there were some issues with the interpretation of that in OA such as curacyte.

Speaker 1

Right. We've taken a number of steps to try to decrease those variations From protocol, the protocol is that we've enhanced the training, we've enhanced the on-site supervision, we have a computer program that directs the physicians as 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 OASIS data, the Zolpi 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.

Speaker 1

So we've been very cognizant of that and set up 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.

Operator

Please stand by for our next question. Our next question comes from Annabel Samimy of Stifel. Hi. Thanks for taking my question.

Speaker 1

Hi, Annabel.

Operator

Good progress. How are you? Good. I had a couple Question 1 is just going back to the Phase 2 design as you're talking about I guess the FDA is not going to be looking at Lower treatment burden as a natural endpoint in Phase II, correct, or in Phase III. That's never going to be one of their endpoints.

Operator

It's always going to be BCVA safety and duration, so just I want to make sure we're clear that we know what That the endpoints haven't necessarily changed as we go into Phase 3, but you're just looking right now at treatment burden?

Speaker 1

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 We understand that. He was very clear that Doctor. Chambers and the group were very clear on saying that Treatment burden cannot be a primary endpoint. We understand that.

Speaker 1

But for our Phase II 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 CLSAX and 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 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 we understand that, but this is more optimal chance of success in Phase 3 without doing it according in a non inferiority trial in Phase 3.

Operator

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 Care was the BISMO or is there something else that they're contemplating that from what you understand is being, I guess, tossed around as different ideas of new guideline requirements.

Speaker 1

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 or even Bebeyslaw in particular makes find that acceptable as a comparator. But I don't think the time they're clear now that that's Not their position. That could change over the next year or 2. But as far as what they I think this is their plan. They're going to let the industry comment on it.

Speaker 1

I'm not sure where it's going to 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, But we'll see. We've had those 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 ODiSI trial, know what we need to do there.

Operator

Got it. And then if I could ask one last question. I know that ODiSI is now going to include treating experienced patients only, but I I understand that you're going to try to minimize the sub responders. Can you just help us Understand why you might want to minimize that population. And if you do have sub responders, are you going to be doing these different analyses within the trial to, I don't know, to separate the matter or identify different responses based on their stages of disease?

Speaker 1

Well, 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 experience, but they were heavily treatment experience. These are people that were referred to as anti VEGF addicts. They were being treated much more frequently than even the label indication for either for the anti VEGFs that they were on. We're not looking for that group.

Speaker 1

We're looking for a group that has shown a positive response to anti VEGFs, But it is not in the category of their needing like a flippers of every 4 to 6 weeks instead of every 8 weeks. We're not looking for the really difficult to control patients, 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 aflibercept. We're trying to get a fair a more 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

Operator

KOLs. Okay. That makes sense. Thank you. Our next question comes from Jonathan Walgreen of JMP.

Speaker 4

Hi. This is Catherine Obicone on for John. And I 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 inferiority, but what would be kind of the goal?

Speaker 1

You mean in terms of I'm not sure I quite understand the question. What's what?

Speaker 4

As far as, I guess Looking at the 2 groups? Yes, between the EYLEA arm and then the your treatment arm, what would be kind of the margin that you guys would be looking for?

Speaker 1

I think we have to be within about 4 letters, 4, 5 letters plus or minus. And it's comparable. We're just looking for 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 of letters of the two groups, we'll be fine.

Operator

Great. And then I just

Speaker 4

have one follow-up question to that. As far as the reduction in treatment burden versus longer duration, which do you feel as more meaningful of the two measures?

Speaker 1

Well, I think they're related. If I can have 80% of my CLS ax patients go 6 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're going to get the 3, yes, 3 of Libercev injections So that duration feeds directly into treatment burden reduction. It's more convenient for the patient, for the caregivers and for on a reimbursement basis.

Speaker 1

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 4 to 8 weeks. So I think the 2 are directly related.

Speaker 4

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?

Speaker 1

Right now, we're looking at we're hoping that all of our patients go at least 4 and the vast majority go To 6 months in terms of duration. I mean, because if you look at what's now in the market, Bovismo says, For example, it can be up to 4 months, but we know that over half their patients need to be retreated before 3 months. IDose EYLEA is being up for approval and they're asking for approval between 3 4 months after quadrupling the dose. So we think there's a lot of room for improvement and excitement by physicians if we can be over 4 weeks up 5 6 weeks. Really, our target is trying to have a twice a year for every 6 months.

Speaker 1

Excuse me, I said weeks. Every, we'll go 4 months to 6 months. Our target really, our hope is that we have a twice a year product.

Speaker 4

Thank you so much.

Operator

Our next question comes from Andreas Arderaj of Wedbush.

Speaker 1

Hi, George. Hi,

Speaker 5

George. Good morning, guys, and thanks for taking my question here. So just maybe a follow-up to some that have already been asked In a different way here. So thinking about or heading into ODiSI here, what is the bar for efficacy in terms of percentage of injection And then If you could provide updates on ongoing business development discussions regarding the use of the suprachoroidal injector? Thanks.

Speaker 1

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 ODiSI trial go 5 to 6 months after the injection. So Without rescue, so we're looking for basically the lowest Degree of rescue possible in the CLSX group. I mean, it's also possible even in the comparator group with aflibercept that they're going to need treatment in between every 8 week doses. So we're looking at that and we're very We think that we're going to get the vast majority of our patients go without need for supplemental therapy, At least 4 and hopefully the vast majority go 5 or 6 months.

Speaker 1

And so that's really all I can tell you. I don't Other groups that have done this have had to have rescue, other groups that are studying certainly the Tyrosine kinase inhibitors have had patients that are enrolled in their studies 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 ODiSI, 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, Right. 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 6 months, just watchful waiting.

Speaker 1

So we want to eliminate that. We want to know If we have something that really works and so we want to put it, we want to put our drug in patients that we know to 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 6 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 We're the only technology that's been used in the clinic. We got 6 trials ongoing now around the world with several different partners, including our own trial.

Speaker 1

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 suprachoroidal microinjector. And so people know if we're clearly the leader In administering drugs in the suprachoroidal 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.

Speaker 5

Okay, great. Thanks for all the updates and my follow-up later. Sure. Yes, no problem.

Operator

Thank you. Please stand by for our next question. Our next question comes from Yi Chen of H. C. Wainworth and Co.

Operator

Yi? Yi, are you able to speak?

Speaker 6

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?

Speaker 1

All right. Can you please repeat?

Speaker 6

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?

Speaker 1

Okay. Charlie, you want to take that question?

Speaker 2

Sure. Yes. So from XIPERE, as we all know, Bausch Alarm has launched that product. They've been very active, training more than 1,000 retinal specialists in the U. S.

Speaker 2

To use IPE. We've Heard had positive feedback, but Bausch has 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, P and L sales and then from 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. But Sorry, but we don't give forecasts on our partners and milestones, regulatory milestones.

Speaker 6

Thank you. My second question is, given the trial design of the ODiSI trial and your comments on treating naive patients, Do you think in real world practice long lasting wet AMD treatment will ever be used on treatment naive patients?

Speaker 1

On treatment night,

Speaker 6

I think with sufficient

Speaker 1

It's why we're going to the group that we're going to first rather than treatment naive. But I do think that in eventually, As more data is obtained on ours and other products, I do think that it's 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.

Speaker 1

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 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. 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.

Speaker 1

So they're being injected 4 times a year, but only seeing and seeing the doctor 6 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 2 months. You can see from the uptake of abysmal right now where it has to go to every 4 months, but not the guarantee because again, like I said earlier, over half better patients needed to be retreated by 3 months. There's been a tremendous uptake in Bevyzmo with that small incremental gain.

Speaker 1

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 4 to 6 months with solid data, I think that will change the treatment paradigm eventually in the physician's office.

Speaker 6

Thank you.

Operator

Thank you. I would now like to turn it back to Doctor. Luzewski for closing remarks.

Speaker 1

I want to thank everyone for joining us this morning on the call. We appreciate your continued interest in ClearSign and we look forward to updating you on our progress.

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