Clearside Biomedical Inc

NASDAQ:CLSD

Earnings Call Transcript 2023-Q1

[Operator]

Good day and thank you for standing by. Welcome to the Clearside Biomedical First Quarter 2023 Financial Results and Corporate Update Call. At this time all participants are in a listen-only mode. After the speakers' presentation there will be a question-and-answer session. [Operator Instructions] 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’s Investor Relations.

[Jenny Kobin, 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 about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 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 formal remarks, we will open the call for your questions.

I would now like to turn the call over to George.

[George Lasezkay, President and Chief Executive Officer]

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 blockades directly inhibiting. VEGF receptors, one, two and three 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 away, since 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 CLS-AX administered to participants who were followed for three months. All participants enrolled in OASIS were heavily anti-VEGF treatment experienced with active disease of screening, which was confirmed by an independent reading center.

This 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 77% 85% reduction in treatment burden as measured by the number of anti-VEGF treatment they received during the six months, compared to the six months, 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 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, a planned randomized double masked, multi-centered 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 our Phase 3 program for CLS-AX in wet AMD.

We believe CLS-AX has the potential to be 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 mg is 6 times a year, and VABYSMO 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 the CLS-AX act 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’ve planned to enroll a total of 60 treatment experienced patients with wet AMD.

Patients will be randomized, or participants will be randomized 2 to 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 drug.

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 or 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 eighth 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, BCA reduction of greater than 5 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 designs 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 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.

Second, this trial is more closely aligned with the recent FDA draft guidance for wet AMD drug development by utilizing aflibercept 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 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 US-based clinical trial sites and expect top line data from the trial in the third quarter of next year.

Moving onto XIPERE. At ARVO Dr. Peter Chang presented survey data regarding the use of our SCS Microinjector from retina to uveitis specialists who have completed at least ten Suprachoroidal injections of XIPERE. The findings from the survey are early adopters of XIPERE 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 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 the 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 of macular edema associated with uveitis, and has completed a Phase 1 clinical trial for the treatment of diabetic macular edema. Data from the DNE 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. REGENEXBIO expects to report additional interim trial data from both trials, including initial data from the most recent cohorts in the second half of 2023.

REGENEXBIO 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 and eye care and in the future our RGX-314 will be referred to as ABBV RGX-314.

Our oncology partner, Aura Biosciences is utilizing our SCS Microinjector to deliver their viral-like drug conjugate bel-sar are for the treatment of colloidal 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 turn the call over to our CFO, Charlie Deignan for a financial update. Charlie?

[Charles Deignan, Chief Financial Officer]

Thanks, George and good morning, everyone. Our financial results for the quarter were published earlier in our press release in are available on our website. Therefore, I will just provide a summary of our financial status. As George mentioned, we're 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, 31st 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 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 PacGrow Healthcare Conference in August. We look forward to these interactions and will keep you updated on our progress. I will now turn the call back over to George for his closing remarks.

[George Lasezkay, President and Chief Executive Officer]

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’s medical and scientific input for our clinical and preclinical research pipeline. Dr. Tom Chula now serves as the chair of our SIB and we have also appointed two well-known retinal physicians as new members of our SIB, Doctors, Arshad Khanani and Lejla Vajzovic.

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 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 a multi-billion dollar wet AMD market. While we were intently focused on advancing CLS-AX, we've also been very active intellectually behind the scenes on our science and SCS delivery.

A research team is experimenting with more advanced injection design, as well as other small molecule candidate that can be delivered it into the Suprachoroidal Space to target a number of retinal diseases. In the ophthalmic medical community, this 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.

[Operator]

Thank you. [Operator Instructions] Our first question comes from Serge Belanger of Needham.

[Serge Belanger, Needham & Company]

Hi, good morning. Couple questions, George.

[George Lasezkay, President and Chief Executive Officer]

Good morning, Serge.

[Serge Belanger, Needham & Company]

I guess, this first one. I think in the past, you’ve mentioned that the Odyssey trial was not covered for its purity or non-impurity. So, how should we think about our successful outcome for this trial? And secondly, I think, looking back aflibercept eh 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.

[George Lasezkay, President and Chief Executive Officer]

On the first question, you're correct. With this study is not powered and to be non-inferiority study or a superior 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 satisfying 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 2, and this is not that uncommon is to go into Phase 2 and not power it in such a way is 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.

So we're not doing it. We are setting up or gathering the data in order for us to properly design and power a Phase 3 programming in wet AMD. And 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 Phse 3 trial. Also we're trying to gauge where we're going to end up terms of the final FDA guidance on trial design in wet AMD, as you know, that the produced a draft guidance and there is a comment period and believe that end of 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 our 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 the patients, going at least for six months on the duration of the post the loading in period versus aflibercept being dosed every eight weeks.

And there was a second part to your question. I'm sorry. I forgot now, so.

[Serge Belanger, Needham & Company]

No problem. It was about the assessment for retreatment,

[George Lasezkay, President and Chief Executive Officer]

Right.

[Serge Belanger, Needham & Company]

Some issues with the interpretation of that in OASIS type.

[George Lasezkay, President and Chief Executive Officer]

Yeah. We've taken a number of steps to try to decrease those variations from protocol into protocol that we have 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 and 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, this 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 setup very rigid protocol to try to eliminate that. I am not sure we can eliminate all of that.

But we've done our best to try to minimize if it’s not eliminated.

[Serge Belanger, Needham & Company]

Thank you.

[Operator]

Please standby for our next question. Our Next question comes from Annabel Samimy of Stifel.

[Annabel Samimy, Stifel]

Hi, thanks for taking my question.

[George Lasezkay, President and Chief Executive Officer]

Hi, Annabel.

[Annabel Samimy, Stifel]

How are you? I had a couple questions. One is, just going back to the Phase 2 design that you are talking about, having not designed for your non-inferiority. I guess the FDA was is not going to be booking at loads and burden as a natural end point in Phase 2, correct or in Phase 3? That's never going to be one of their endpoints. So it’s always going to be BCA safety and treat and duration.

So just, I want to make sure we're clear with that. What the good the endpoints have necessarily changed as we go into Phase 3. But you're just looking right now at treatment burden.

[George Lasezkay, President and Chief Executive Officer]

We're looking at maintaining a stable visual acuity. And we're doing a treatment burden and the reason for it is, you're right about what the draft guideline say. We are very - we understand that. It was very clear that Dr. Chambers and the group were very clear in saying that the treatment burden cannot be a primary endpoint. We understand that.

But for our Phase 2 trial, 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, and obviously going to phase 3, unless the draft guidelines change with their final version, treatment burden would not be a primary endpoint in and of itself in a Phase 3 trial and then the FDA's made that pretty clear.

It's very clear they're focused on safety and they are very clear they are focused on vision. So, we understand that. But this is more to give us the kind of information to see, do we have 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 in a non-inferiority trial and in Phase 3, so.

[Annabel Samimy, Stifel]

Okay. Got it. And just go on the draft guidelines. What are some of the potential changes that you might possibly be facing to these guidelines? I mean, are they contemplating potentially a different standard of care with the VABYSMO or is there something else that they're contemplating that or from what you understand as being, I guess, VABYSMO just has different ideas of new guideline requirements?

[George Lasezkay, President and Chief Executive Officer]

I don't have - 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 will be comments coming in from many, 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 the bizmo, as an acceptable or VABYSMO in particular makes find that acceptable as a comparator.

But I don't think they are clear now, that that's not their position. That could change over the next year or two. But as far as what they plan, I think this is their plan, they're going to let the industry comment on it. I'm not sure where it's going to come out. I think there are some things about the comparator arm that we’re a little unclear to some of us in the industry and either require clarification to change. But we'll see. We had those kind of 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, what we need to do there.

[Annabel Samimy, Stifel]

Got it. And then, if I could ask one last question? Odyssey is not going to 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 want to minimize that population? And if you do have sub responders, are going to 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.

[George Lasezkay, President and Chief Executive Officer]

Well, what we're really trying, we're trying to get – and based on the conversations we 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. And if you remember the OASIS trial, they were treatment experienced, but they were heavily treatment experienced.

These are people that were referred to advantage of just addicts. They were being treated much more frequently than even the label indication for either for the anti-VEGF 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 their needing like aflibercept every four to six weeks instead of every eight months – or eight 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 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 are just trying to take this group that we think is the most relevant group certainly in the opinion of our KOL.

[Annabel Samimy, Stifel]

Okay. That makes sense. Thank you.

[Operator]

Thank you. Please standby for our next question. Our next question comes from Jonathan Wolleben of JMP.

[Unidentified Analyst]

Hi, this his is Katherine [Indiscernible] on for Jon. We just had a question about what non-inferiority margins you want to shift in terms of BCVA. I know, in Odyssey, you guys are from the top for the non-inferiority, but what would be kind of the call?

[George Lasezkay, President and Chief Executive Officer]

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

[Unidentified Analyst]

As far as, I guess, I think

[George Lasezkay, President and Chief Executive Officer]

Looking at the two rules?

[Unidentified Analyst]

Yeah, between the EYLEA arm and then your treatment arm. What would be kind of the margin that you guys would be looking for?

[George Lasezkay, President and Chief Executive Officer]

I think we have to be within about four letters or 4, 5 letters plus or minus. Katherine, 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 if I think between the two groups as long as within a couple letters of the two groups where we find.

[Unidentified Analyst]

Great. And then I have one follow-up question to that. As far as the reduction treatment burden versus longer duration, which is still a more meaningful of the two measures?

[George Lasezkay, President and Chief Executive Officer]

Well, I think they're related. If I can, if I can have 80% of my CLS-AX expectations goes six months, I've got a very clear treatment burden reduction. So, I think the duration is related directly to treatment burden. So, I mean, if you look at that period of time, you know you're going to get three, yeah, three aflibercept injections to one CLS-AX injection.

So, that duration feeds directly into treatment burden reduction. It's more convenient for the patient for the caregivers for and for on a reimbursement basis. So it's better all around, and there's a many of us that are trying to have this extended duration of therapy that 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 three, four to eight weeks. So I think the two are directly related.

[Unidentified Analyst]

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 the two?

[George Lasezkay, President and Chief Executive Officer]

Right now, we're looking at, we're hoping that all of our patients, go at least four and the vast majority go to six months in terms of duration, And if you look at what's out what's now in the market VABYSMO says, for example, it can be up to four months, but we know that over half of 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. So we think there's a lot of room for improvement and 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 month. Or excuse me, I said weeks - every go four months to six months, our target really our hope is that we have a twice a year target.

[Unidentified Analyst]

Thank you so much.

[Operator]

Thank you. Please standby for our next question. Our next question comes from Andreas Argyrides of Wedbush.

[George Lasezkay, President and Chief Executive Officer]

Hi, Andreas.

[Andreas Argyrides, Wedbush Securities]

Hi, George. Hey George. Good morning, guys. And thank you for taking the question here. So just maybe a follow-up to some that have been asked in a very different way. So, thinking about 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 the competitors? And then, if you could provide updates on ongoing business development discussions regarding the use of the Suprachoroidal Injector? Thanks.

[George Lasezkay, President and Chief Executive Officer]

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 so, without rescue. So, we're looking for basically the lowest degree of rescue possible the CLS-AX group. I mean, it's also possible even in the comparator group of aflibercept that they're going to need treatment in between their every eight 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 four and hopefully the vast majority go five or six months. And so, that's really all I can tell you. I don't - other groups that have done this had have 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 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, 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 six months. And just watch we are waiting.

So, we want to eliminate that. We want to know if we have something that really works until we want to put it. 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 that the vast majority of the patients go forward 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 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 US.

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 that 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.

[Andreas Argyrides, Wedbush Securities]

Okay, great. Thanks for all the updates and we'll follow up later.

[George Lasezkay, President and Chief Executive Officer]

Sure. Yeah, no problem.

[Operator]

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?

[Yi Chen, H.C. Wainwright]

Hello.

[Operator]

Yes, hello, Yi.

[Yi Chen, H.C. Wainwright]

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?

[George Lasezkay, President and Chief Executive Officer]

All right, Yi. Please repeat.

[Yi Chen, H.C. Wainwright]

I was asking that could you give us some additional color on XIPERE commercial performance and how should be projecting license revenue going forward?

[George Lasezkay, President and Chief Executive Officer]

Okay. Charlie, do you want to take that question?

[Charles Deignan, Chief Financial Officer]

Sure. Yeah. So, from XIPERE, as we all know that Bausch + Lomb has launched that product. They've been very active with training more than 1,000 retinal specialists in the US to use XIPERE. We've heard had positive feedback, but Bausch has - we were 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 partnering estimates that we don't give out revenue forecast. 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 a forecast on our partners, in milestones regulatory milestones.

[Yi Chen, H.C. Wainwright]

Thank you. And my second question is, given the trial design of the Odyssey trial and the comments treatment naïve patients, do you think in real world practice, long lasting wet AMD treatment will ever be used on treatment naïve patients?

[George Lasezkay, President and Chief Executive Officer]

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 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 of the norm. Obviously, physicians will work based on what is that 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 other’s 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 of it is develop, 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 you're being seen every month and demonstrating stable BCVA and their degree of fluid is holding reasonably stable, maybe they're injected in 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 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 has been a tremendous in VABYSMO 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.

[Yi Chen, H.C. Wainwright]

Thank you.

[Operator]

Thank you. I would now like to turn it back to Dr. Lasezkay for closing remarks.

[George Lasezkay, President and Chief Executive Officer]

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.