Stephen Kilmer - Investor Relations Daniel White - Chief Executive Officer Glen Noronha - Chief Scientific Officer Charlie Deignan - Chief Financial Officer Brion Raymond - Chief Commercial Officer.

Liana Moussatos - Wedbush Securities Serge Belanger - Needham & Co..

Good day, ladies and gentlemen and welcome to the Q1 2018 Clearside Biomedical Earnings Conference Call. Currently at this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

[Operator Instructions] At this time, I like to turn the call over to your host, Stephen Kilmer, Investor Relations. Please go ahead..

Thank you. Good morning, everyone, and thank you for joining us. 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 the 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 most recent annual report on Form 10-K on file with the SEC, which can be accessed on the Edgar database at www.sec.gov and the other filings we make with the SEC from time to time.

In addition, any forward-looking statements represent our views only 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 at some future point, we specifically disclaim any obligation to do so, even if our views change.

These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today.

On the call today representing Clearside are Daniel White, Our President and Chief Executive Officer; Charlie Deignan, our Chief Financial Officer; Glen Noronha, our Chief Scientific Officer; and Brion Raymond, our Chief Commercial Officer. With that said, I’ll now turn the call over to Daniel..

Thank you, Steve. Good morning, everyone and thank you all for joining us on the call today. Before we begin, let me briefly layout the agenda for today’s call.

I’ll be catching you up on the Clearside story, Brion will provide some commercial color to highlight our near-term market opportunity in non-infectious uveitis, Glen will then take you through the details of our clinical development programs, Charlie will discuss our financial results, and finally I will summarize our discussion in the end.

We will then have time at the end of the call for Q&A. For the benefit of those who are new to the Clearside Biomedical story, I’d like to start off by taking a moment to highlight our company’s mission. Clearside is developing transformative solutions designed to restore and preserve vision.

As a company, we take on challenges of finding better solutions for sight threatening diseases such as uveitis, Retinal Vein Occlusion or RVO, and Diabetic Macular Edema or DME where Macular Edema is a common complication. Clearside is unique in that we hold proprietary access to 17 square centimeters of the eye called the suprachoroidal space.

Through Suprachoroidal injection of drug candidates we provide a unique distribution of drug for treating diseases of the retina and choroid.

Our successful follow-on public offering completed early March, in which we raised 80 million in net proceeds that puts us in a strong financial position to continue executing our development programs, and treating sight threatening diseases and putting together our first NDA submission in the non-infectious uveitis, and make prelaunch preparations.

In that regard, I would like to begin with a brief update on where we currently stand at our three most advanced clinical development programs.

In each of them, suprachoroidal injected CLS-TA, a proprietary suspension formulation of the corticosteroid triamcinolone acetonide, is being evaluated either alone or with an anti-VEGF agent as a potential treatment for sight threatening disease of retina and choroids.

Let’s start with our first and most advanced program suprachoroidal CLS-TA being developed for the treatment of macular edema associated with non-infectious uveitis.

In March, we announced positive top line results from our pivotal Phase 3 PEACHTREE clinical study of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis. The primary and key secondary endpoints were successfully achieved in the trial.

Suprachoroidal CLS-TA became the first drug candidate to be evaluated in a pivotal Phase 3 trial using improvement and visual acuity as a primary endpoint in patients with the uveitic macular edema.

A little later in today's call, our CFO, Glen Noronha, will provide a brief summary of these top line results and update you on some additional announcements performed subsequent to the March release.

We expect to submit an NDA for suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis to the FDA in the fourth quarter of 2018. We are also evaluating a number of options for potential submissions to regulatory agencies in additional territories outside the US.

Simply put, the release of positive top line data from PEACHTREE marked a potential inflection point for Clearside as it could help pave the way for us to successfully transition from a clinical stage company to a commercial stage company next year. To help lead the transition, we are recruiting Brion Raymond to be our new Chief Commercial Officer.

In that role he is responsible for managing the development and execution of a comprehensive commercial strategy for Clearside’s pipeline of treatments targeting sight threatening diseases if approved by the FDA. Brion was a key member of the team at Genentech responsible for launching a widely used ophthalmic drug called lucentis.

So he brings a tremendous amount of relevant ophthalmic experience in retinal specialist relationships to Clearside. In a few moments, I will ask Brion to provide some more details on the attractive uveitis market opportunity we see ahead of us.

Our second most advanced program is suprachoroidal CLS-TA used together with an intravitreal administered anti-VEGF agent for the treatment of RVO. RVO is a sight-threatening disorder resulting from a blockage of one or more veins carrying blood out of the retina.

According to a 2010 study published in the Journal of Ophthalmology, RVO is estimated to affect more than 16 million adults worldwide. Of those, we estimate approximately 2.2 million reside in the United States. There is a significant need to develop new treatment approaches for RVO that are both effective and more durable.

Our objective is to show that suprachoroidal CLS-TA used together with an intravitreal anti-VEGF agent can result in earlier, superior visual acuity outcomes as compared to monthly injections of intravitreal anti-VEGF alone in newly diagnosed RVO patients.

Ideally, we would like to see better visual outcomes in the early phase of the disease, and if we achieve that we believe that we have a better opportunity to preserve vision over the long term. I'm pleased to report that we are now nearing completion of patient enrolment in our first of two RVO Phase 3 clinical trials SAPPHIRE.

SAPPHIRE is looking at suprachoroidal CLS-TA in combination with anti-VEGF agent Eylea. We expect to report top line eight week data from SAPPHIRE trial in the second half of ’18.

In March, we also announced enrolment of the first patient in TOPAZ, second Phase 3 clinical trial, a suprachoroidal CLS-TA used with an intravitreal anti-VEGF agent in patients with RVO. The design of TOPAZ is similar to SAPPHIRE with one key difference.

In this second trial, we are looking at suprachoroidal CLS-TA used together with one of two different intravitreal anti-VEGF agents Lucentis or Avastin.

If the primary endpoints are met in both SAPPHIRE and TOPAZ trials, we intend to seek a [class label] United States, which if included as part of the market authorization and approved by the FDA, allow suprachoroidal CLS-TA to be used together with an anti-VEGF agent for the treatment of RVO.

Our work in RVO in part also laid the groundwork for us to expand our development programs for CLS-TA to include another retinal vascular condition, DME, or diabetic macular edema. DME is the most common cause of visual loss in people with diabetes mellitus. It affects up to 30% of people who have had diabetes for 20 years or more.

And if left untreated, it may lead to moderate visual loss. While the current standard of care in treating patients with DME is through the use of intravitreal anti-VEGF agents there is still substantial unmet need for this large patient population.

We believe that eye complications associated with diabetes are caused by multiple pathways and even repeated monthly injections of VEGF inhibitors for six months, approximately 40% of DME patients have insufficient response to treatment.

We believe that suprachoroidal CLS-TA used together with intravitreal anti-VEGF agent has the potential to improve patient outcomes, including to reduce the treatment burden for newly diagnosed DME patients as both corticosteroids and anti-VEGF agents have been shown to be effective in the treatment of this disease.

Later this quarter, we expect to announce top line data from our TYBEE trial, and hope to be able to show the potential benefit of CLS-TA in a DME patient population. TYBEE is a controlled, randomized mass Phase 3 clinical trial of CLS-TA used together with Eylea in patients who are naïve to treatment for DME.

I will now turn the call over to Brion to provide a brief commercial update on uveitis.

Brion?.

Thanks Daniel. Uveitis is a set of inflammatory conditions affecting the eye, and is one of the world’s leading causes of blindness.

Macular edema is the build-up of fluid in the macula, an area in the center of the retina and responsible for sharp, straight ahead vision, and has been implicated as the leading cause of vision loss in patients with non-infectious uveitis.

Suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis if approved by the FDA represents an attractive potential market entrance opportunity. The global uveitis market is expected to reach over $1 billion by 2024 and in the United States affects approximately 350,000 patients.

Of these, about a third of these patients develop macular edema, secondary to non-infectious uveitis.

Currently there are no approved therapies to treat uveitic macular edema and despite available treatment options for non-infectious uveitis up to 50% of uveitic macular edema patients continue to present with persistent macular edema after completion of a uveitis treatment.

Further rates of IOP events, associated with today’s approved intravitreal steroids, which are often used for non-infectious uveitis, range from 25% to 60% depending on the therapy.

We believe this persistent macular edema after treatment and these rates of IOP events associated with the currently approved local steroid therapies represent a significant unmet need for uveitic macular edema patients.

We are now building a commercial team with decades of experience in ophthalmology, who are committed to educating, training and supporting uveitis and retina communities.

Our launch experience expands all areas of commercial expertise, including marketing, access and reimbursement, sales and market analytics, and we are ready if the FDA approves Suprachoroidal CLS-TA to efficiently reach the approximately 1900 uveitis and retina specialists, who manage these patients in the US.

We are rapidly growing our team and we are excited about the market opportunity in front of us and the possibility of bringing a new option to uveitic macular edema patients.

With that I will turn the call over to our Chief Scientific Officer, Glen Noronha, to provide some details on the PEACHTREE results in uveitis and on our programs in RVO and DME..

Thank you, Brion. As we have discussed, the PEACHTREE trial top line results in two previous calls, rather than going into a great amount of detail I will begin by providing a brief summary of the data to focus our discussion. PEACHTREE enrolled 160 uveitis patients across 64 clinical research sites in the US, Israel and India.

Patients were randomized 3 to 2 to receive two suprachoroidal CLS-TA injections or two sham procedures 12-weeks apart. As Daniel mentioned, this trial met its primary endpoint.

In PEACHTREE, 47% of patients who received suprachoroidal CLS-TA gained at least 15 letters in BCVA from baseline as measured at week 24, compared to 16% of patients who underwent sham procedures. This improvement was statistically significant with a P value less than 0.001.

In terms of improvements in BCVA, the change from baseline was better than the treatment arm than in the controlled sham arm at each monthly evaluation.

The mean improvement in BCVA that was seen as early as week four was maintained throughout the evaluation period with 9.6 letters gained at week four, and 13.7 letters gained at week 24 in the active arm compared to 1.2 letters gained at week four, and 2.9 letters gained at week 24 in the control arm.

These improvements in mean changes in best corrected visual acuity was statistically significant. For the other key secondary endpoints, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline of 157 microns in central subfield thickness at week 24 in the active arm, compared to 19 micron mean reduction in the control arm.

The result that was also statistically significant with a P value less than 0.001. Suprachoroidal CLS-TA was generally well tolerated and there were no treatment related serious adverse events reported in this trial. 97% of patients completed the trial.

Through 24-weeks of the trial steroid related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA group, compared to no patients in the sham group.

In addition, adverse event changes in cataract grading from baseline over the course of this 24 week trial was similar in each arm at approximately 8%. Further, that were no cataract surgeries resulting from this trial. As we have continued to analyze this data, some additional positive observations have come to light.

For example, over two thirds of the patients in the CLS-TA arm, who had any level of inflammation at baseline resolved in each of the three commonly used measures of inflammation in the eye. These are the anterior chamber cell measurements, the anterior chamber flare and vitreous haze.

With respect to vitreous haze measurements, 69% of patients with any level of vitreous haze at baseline resolved by the week 24 study exit visit. That is these patients showed scores of zero, implying that their vitreous haze had resolved. This contrasts with only 7% of control arm patients, who resolved by week 24.

The resolution of anterior chamber cells and anterior chamber flare was 72% and 74% respectively in the CLS-TA arm compared to 17% and 22% in the control group. In other words, in all three cases of measures of signs of inflammation there was at least a 50% additional improvement in each measure when comparing the CLS-TA arm to the control arm.

With respect to the potential for durability of CLS-TA, who over 85% of the patients in the CLS-TA arm did not receive any additional therapy over the 24 weeks of the trial compared to only between 30% to 35% of patients in the control arm in the study, who did not receive rescue therapy.

We are continuing to evaluate a subgroup of the trial subjects for an additional six months to understand further the durability of CLS-TA.

Since over 85% of patients in PEACHTREE in the CLS-TA arm did not require additional therapy during the trial, this additional follow-up for another six months in a subgroup of patients from PEACHTREE will provide useful information to understand the durability of effective CLS-TA in these uveitic macular edema patients.

We are in the process of receiving all our final data sets and putting together the various sections of the NDA. All aspects of this effort are on track. We are expecting to submit our NDA for suprachoroidally injected CLS-TA for uveitic macular edema in the fourth quarter this year.

We are also in the process of evaluating other key territories outside the US to better understand what is required and put in place a filing strategy. Now let us turn our attention to our retinal vein occlusion program.

As Daniel highlighted, in addition to our use of suprachoroidal CLS-TA as a monotherapy in patients with uveitis, in RVO we are exploring whether suprachoroidal CLS-TA along with an intravitreal anti-VEGF agent as a combination therapy can provide improved visual acuity, reduce macular edema and reduce treatment frequency as compared to administration of intravitreal anti-VEGF agents alone.

The medical literature provides evidence that corticosteroids and intravitreal anti-VEGF agents each have known advantages in the management of RVO, when used intravitreally.

Our first randomized controlled, double masked, multicenter, multicountry Phase 3 clinical trial for the potential treatment of patients with RVO called SAPPHIRE is being conducted with an expected enrolment of approximately 460 patients at approximately 150 investigational sites across 18 countries.

Patients in SAPPHIRE being randomized either to the combination arm, in which they will receive suprachoroidal CLS-TA together with intravitreal Eylea, or to a control arm in which patients will receive intravitreal Eylea alone.

Patients will be evaluated every four weeks after randomization with safety and efficacy analyses performed at week 8 and week 24. After 24 weeks, patients in both arms will be followed for approximately an additional six months.

The primary outcome of the SAPPHIRE trial is to determine the proportion of patients in each arm with a BCVA improvement of 15 or more letters from baseline at eight weeks after initial treatment.

In the previously reported TANZANITE Phase 2 trial in treatment naïve patients with RVO, where additional treatments were on an as needed basis after initial treatment at randomization, 61% of patients had received the combination treatment with CLS-TA and Eylea at baseline achieved a more than 15 letter improvement in BCVA at eight weeks.

As Daniel mentioned, we are now enrolling patients in our second Phase 3 RVO trial called TOPAZ. TOPAZ is a multicenter, randomized, masked, controlled trial to assess the safety and efficacy of suprachoroidal CLS-TA used with two intravitreal anti-VEGF agents, Lucentis or Avastin in treatment naïve patients with RVO.

The design of this trial is similar to that of the SAPPHIRE trial.

Patients in the combination arm of the trial will receive suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at the beginning of the trial; an intravitreal anti-VEGF agent alone at week 4 and suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at weeks 12 and 24.

Patients in the control arm will receive an intravitreal anti-VEGF agent alone at the beginning of the trial and every four weeks thereafter through week 24. After 24 weeks, patients in both arms will be followed for approximately an additional six months.

The primary outcome of this trial will be to determine the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated.

We anticipate total enrolment in TOPAZ to be similar to that of the SAPPHIRE Phase 3 trial. I want to turn our attention now to the other major retinal vascular condition we are seeking to treat, diabetic macular edema, in which we have our third political program.

Before the end of the current quarter we expect to release preliminary data from a multicenter, randomized, masked, controlled Phase 2 trial called TYBEE, designed to evaluate suprachoroidal CLS-TA along with intravitreal Eylea compared to intravitreal Eylea alone in a control arm in patients with DME over a six-month evaluation period.

In this Phase 2 trial, patients with DME were randomly assigned one to one to either a combination arm or to a controlled monotherapy arm only receiving intravitreal Eylea. The trial has a fixed treatment portion for the first three months followed by an as needed portion.

While safety and efficacy will be evaluated in this trial the primary outcome measure will be the mean change in best corrected visual acuity from baseline where data from the combination arm will be compared to that from the monotherapy arm.

Previously in our DME program we completed the Phase 1/2 HULK clinical trial, where we evaluated suprachoroidal CLS-TA without or without intravitreal Eylea in patients with DME. While safety was the primary outcome from this trial, we also evaluated changes in best corrected visual acuity and in macular edema over a six-month evaluation period.

In this trial, CLS-TA was generally well tolerated and there have been no serious adverse events related to the treatment. Further there were encouraging efficacy signals in terms of visual and anatomical improvements with the trend towards durability, particularly in the combination treatment arm.

In HULK, anatomical improvement was observed in all treated eyes, with more than two thirds of those eyes achieving a greater than 50% reduction in excess central retinal thickness through the six-month evaluation period following initial treatment.

In the treatment naïve group, 40% of patients did not require pre-treatment over the entire six months with an additional 20% requiring only one treatment. As you can see the development teams have had a busy and productive first quarter and we are really grateful for all their efforts.

I will now turn the call over to our Chief Financial Officer, Charlie Deignan, to review our first quarter 2018 financial results.

Charlie?.

Thanks Glen. As we reported this morning, our research and development expenses were $13.4 million for the Q1 2018, compared to $7.6 million for the same period in 2017.

As expected, we had an increase in R&D costs associated with our clinical development programs in RVO, and DME, partially offset by decrease in costs associated with our uveitis program as PEACHTREE is being completed.

As Daniel and Glen highlighted in their opening remarks today, we have been advancing our development programs with the reporting of top line data for our Phase 3 trial for macular edema associated with non-infectious uveitis in March.

The continuing enrolment of patients in our Phase 3 trials for RVO and the completion of enrolment in Phase 2 trials for DME in October 2017 with top line data being reported out later this quarter. General and administrative expenses in the fourth quarter of 2017 were $3.1 million, up from $2.7 million in the 2017 first quarter.

The Q1 2018 loss of $16.6 million or $0.62 per share, compared to $10.4 million or $0.41 per share for the same period in 2017. Cash used in operating activities for the first quarter in 2018 was approximately $15.7 million. As of March 31, 2018 cash, cash equivalents and short-term investments totaled $101.1 million.

We believe we have sufficient cash on hand to fund operations and begin commercialization activities in advance of the potential loss of our first product.

Our goal is to report data from the first of our two Phase 3 trials in RVO before the end of the year and we expect to have approximately a year of cash remaining after that, bringing us into the fourth quarter of 2019. With that I will turn the call back over to Daniel for his closing remarks.

Daniel?.

Thank you, Charlie. I want to personally thank our shareholders for their continued support for the Clearside strategy, which continues to demonstrate our greater utility for treating complex, sight-threatening eye diseases using the unique drug distribution provided by suprachoroidal delivery. This concludes our prepared remarks for today.

Before I open the call to questions, I’d like to express my thanks to the entire Clearside team for the significant progress we made in the first quarter. We have a strong and highly capable team of professionals that are consistently delivered on our key goals, and we appreciate their commitment to our mission.

With that, we now open the call for questions.

Operator?.

[Operator Instructions] Our first question comes from Anupam Rama of JP Morgan. Please go ahead..

Hi, guys. This is [indiscernible] for this morning. Thank you for the update here and for taking our question.

So one from us on the safety data presented in the press release, how best to put the information into context here, how early did the signs in inflammation resolve and how you expect this to change with longer treatment duration with suprachoroidal CLS-TA.

And then related to this can you comment on what the rate of IOP increases have been across all reported studies that you have done with CLS-TA. I think I had about an 8% increase sited pre-PEACHTREE and just wondering where you are about now? And then maybe one more if I could related to the NDA filing.

If there are any other gating factors still before the submission and also any other data that we can still expect around the pivotal trial. Thank you so much guys. I appreciate it..

Thanks. You fired four of them – four questions at us. So we will cover them one at a time. So let us talk about – I'm going to start with your last question on the NDA – on the filing, we are still putting together the data from PEACHTREE and preparing the following information. Everything looks great for this year.

So, we are not anticipating really any gating factors from where we stand today; just putting the information together completing the preparations to get the NDA done.

On the safety data, kind of how it might be assigned across and the signs of inflammation and rate of IOP increase, I'm going to assign that to Glen if he doesn’t mind to answer those questions..

Thank you, Daniel. And thank you for the questions Tessa. The resolution of the signs of information was seen from the first visit that was at week 4, and they were consistent and they were sustained through the entire 24 weeks of the study. In fact, if anything at all, the trend was towards an improvement in the signs as you went through the trial.

The second question was about the IOP rates of increase. We have not done any detailed cross-trial comparisons, but the rates that you are seeing are as high as they get. So the approximately 8% that you mentioned or 10%, around the rates are the – we have not seen anything outside of that.

And this is – just as a reminder, PEACHTREE was two doses of CLS-TA given 12 weeks apart. So our approximately 10% rate in PEACHTREE that we have shown 11% is from two doses of CLS-TA. And the last thing I think Daniel already addressed to your question about the NDA, which is there are no gating factors and we are on track..

Thank you so much Daniel. Thank you so much Glen. I appreciate it guys..

Thanks, Tessa..

Thank you. Our next question comes from Annabel Samimy of Stifel. Your question please..

Hi guys. This is Anthony in for Annabel. Thanks for the additional data on the uveitis study. Just a follow on, how many patients achieved complete resolution of the macular edema? I think in the Phase 2 you sited it is less than 310 microns.

Wanted to know what was that in the Phase 3, and then on the RVO part of it, within the RVO Phase 2 study can you tell us whether you saw a different response between CRVO patients and BRVO patients.

Was the study arms balanced between the active and placebo and are you being discerning about the composition of the Phase 3 trial between these patients, or is it just randomized between the two types? Thanks guys..

Okay. So there are three questions I caught in there. One was the resolution of the CME and the uveitis study. The second one was the RVO and the RVO Phase 2, the balance of both CRVO versus BRVO, and then the last one was how that randomized in the Phase 3. So Glen, those are preferable for you to grab if you don't mind..

Thank you, Daniel, and thank you for the question. With regard to the resolution of macular edema and uveitis, we expect that it is well over 50%. Those details will be provided at an upcoming medical conference. You had asked about the CRVO, BRVO analyses from the Phase 2.

Those data have been published late last year, but the response in CRVO and BRVO with regard to the analyses based on the primary endpoint was similar. Those are small numbers within that study. We did not stratify the Phase 2 study. We took anyone who came in.

With regard to the Phase 3, it is deliberately stratified, so there is a cut-off at approximately 50% in each of those trials. So we will have approximately equal numbers of central and branch retinal vein occlusion patients in each of the two Phase 3 trials..

And just to follow up, is there a difference – you noted that there is no real difference response, but would you expect there to be in the Phase 3 at all?.

We don't have the data from the Phase 3 yet, so I wouldn't speculate until we have the data..

Thank you..

Thank you. Our next question comes from Liana Moussatos of Wedbush Securities. Your question please..

Thank you for taking my question.

The US commercialization, you mentioned 1900 specialists, how many reps do you anticipate hiring, and also for TOPAZ do you anticipate preliminary data release like with SAPPHIRE maybe next year?.

Thanks Liana. So the two questions, I will hand the first question on commercialization over to Brion in one second, but to your question about TOPAZ, will we have top line data next year? We haven't guided on that yet. TOPAZ is just now starting off.

We are really pleased with how SAPPHIRE has enrolled, but let us see how TOPAZ starts to enroll as the year goes forward, and we will guide on that later on in the year how about that. And then, as far as the number of reps, the commercialization plans for this community, Brion, you cover that..

Sure and thanks for the question. We plan a sales force approximately the size of the other sales force – the retinal sales forces that are out there, anywhere between 25 and 40 sales reps, which is quite small compared to normal sales forces, and especially with this type of market opportunity.

But we feel we can efficiently reach all 1900 specialists with the sales force of that size and they will be supported with other field teams such as reimbursement managers, as well as MSOs..

Okay and going back to TOPAZ.

Do you plan to release preliminary data from the trial like you are doing with SAPPHIRE even if it is not next year?.

There we haven't decided on that. Yes, I will probably guide on that a little later. But, yes, so let me guide on that later on in the year.

Obviously, we are just getting this trial off the ground, covering the sites and this is covering three continents, and we are making sure that we have a global statistical plan that we will be able to employ to have a global product. Thanks..

All right. Thank you..

Thank you. [Operator Instructions] Our next question comes from Serge Belanger of Needham & Co. Your question please. .

Good morning. A couple of questions on the uveitis program, first, you now have the data in hand for two months, just wanted to get a feel for the physician feedback you are getting.

I assume comparing the data to what they have seen with [indiscernible] – I guess what excites them the most, is it the efficacy of CLS-TA or the safety profile?.

Thanks for the questions, Serge. So I would say that there is – and I will let Brion kind of comment on what I have to say as well. What we heard from the physicians thus far is, first of all, the fact that we went after the best corrective visual acuity endpoint for this disease. It is one of the most important factors.

They feel like that is a standard that is as far as the good standard as it relates to their patients making them see better, as well as they feel like that the FDA will respect that gold standard. Second is the fact that unlike [indiscernible] went after posterior uveitis, we went after all types of uveitis.

So, in including all of these categories we really assumed by the data that Glen just talked about in the resolution of the signs and symptoms of haze, and flare and so those outcomes on top of the best corrective visual equity was very powerful in all types of uveitis. And so that just expands the potential for our market even greater.

And then with the side effect profile, they anticipate steroids to have much higher levels of cataract this time in a six-month time point, as well as IOP increases, and so we have been very consistent to the data that we have shown in the pivotal trial, as we have shown in previous studies.

So they feel confident in that and they feel confident in the fact that we will be able to replicate that in future trials and in future studies on the safety side.

So, Brion, if you have anything else…?.

No, I agree along those lines. For those that have seen the press release, the efficacy data is very attractive to them. And as well as what they view as a reduction in IOP events compared to other steroids.

And I would also underscore the excitement about having a new procedure and being able to access a part they have never been able to access before, and that is really most of – those three things are the things that they raise to us in discussions as being the most exciting parts of the CLS-TA..

Okay.

And just thinking about the market opportunity in uveitis, clearly there is a variety of different corticosteroid options here, you can just describe the treatment paradigm, patients typically start off on oral steroids or drops, and then eventually move on to IVT injections or implants and I guess, where would CLS-TA fit within that paradigm?.

Well, our target is first line. If a patient shows up macular edema, secondary to uveitis, our goal is to have them reach for CLS-TA. Right now many individual steroids are being held later in the process to help clean up any existing or remaining information of macular edema, but we would like to be this first line..

And then one question on the upcoming DME data set that we will see, I guess, over the next month or so, so primary endpoint is visual acuity, I guess, how would you describe the different scenarios of a win here.

Would a reduction in the number of Eylea injections be considered a win here, and allow you to proceed to Phase 3 development?.

Yes. So, this is Daniel. And that is a great question.

When we see that this particular category of retinal vascular disease in diabetic macular edema, these patients come in with a whole array of natural history and what we are anticipating if we can show equivalence to six monthly injections of Eylea at the end of this study with two treatment one at a time zero, one at month three with the combination.

We feel like that is a win because you don't want to be going into these diabetic patients, more often than you need to be, and identifying the right group within that population to look at our design of our Phase 3. That is why we are doing the Phase 2 in the first place. So I think that will be a win.

If we see visual outcomes that are better than the monthly VEGF obviously, we see that even more of a win. But clearly this is an area that we have shown strong anatomical outcomes in previous studies; steroids have shown to be very effective in this condition.

We feel like we are going to be watching all of those outcomes to tell us what to do next in the Phase 3..

Okay. Thank you..

Thank you. This concludes our Q&A session. At this time I like to turn the call back to Daniel White, President and Chief Executive Officer for closing remarks. Please go ahead..

Thank you so much. Thank you once again for joining us on the call today. We appreciate your continued interest in Clearside, and we look forward to updating you on our progress in the months ahead. Operator, you may now disconnect..

Thank you. Thank you, ladies and gentlemen for attending today's conference. This concludes our program. You may all disconnect. Good day..