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

Annabel Samimy - Stifel Liana Moussatos - Wedbush Serge Belanger - Needham Donald Ellis - JMP Securities.

Good day, ladies and gentlemen and welcome to the Clearside Biomedical’s Fourth Quarter and Full-Year 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be provided at that time.

[Operator Instructions] I’d now like to turn the conference over to Stephen Kilmer with 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 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, 2016 to be filed with the SEC on or about March 16, 2018, which can be accessed on the Edgar database at www.sec.gov and 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 with the Clearside side, Glen will be taking you through the details of our main clinical development programs, Charlie will discuss our financial results, and finally I will summarize our discussion and we will then have time at the end of the call for Q&A.

For the benefit of those who are new to Clearside Biomedical story, I’d like to take a moment to highlight our company’s mission. Clearside is developing transformative elegant precise 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 and that we hold proprietary access to 17 square centimeters in the eye called the suprachoroidal space.

Suprachoroidal injection of a drug candidate provides a unique distribution of drug for treating diseases of the retina and the choroid. I like to begin with a brief update on where we currently stand with our three most advanced clinical development programs.

In each of them, CLS-TA for suprachoroidal administration, a proprietary suspension formulation of the corticosteroid triamcinolone acetonide is our product candidate. 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.

Uveitis is a set of inflammatory conditions effecting the eye and one of the world’s leading cause of blindness. Macular edema is the build-up of fluid in the macular, an area in the center of the retina responsible for sharp straight-ahead vision. Fluid build-up causes the macular to swell and thicken which distorts vision.

Suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis, if approved by the FDA represents a very attractive potential market entrance opportunity.

The global uveitis market is expected to reach over $1 billion by 2024 and then the United States, non-infectious uveitis remains one of the leading causes of blindness effecting approximately 350,000 patients. Macular edema occurs in approximately one-third of all non-infectious uveitis and is a major contributor to vision loss in these patients.

In early last week, we announced positive top line results from our pivotal Phase 3 PEACHTREE clinical trial of Suprachoroidal CLS-TA in places with macular edema associated with non-infectious uveitis.

The primary and key secondary endpoints were successfully achieved in the trial validating our proprietary approach using Suprachoroidal CLS-TA to become the first drug candidate in a pivotal Phase 3 trial using improvement in visual acuity at a primary endpoint in patients with macular edema.

Our CFO, Glen Noronha will provide some granularity in the topline results a little later in today’s call. Detailed results from the PEACHTREE trial will be presented at an upcoming medical conference.

We expect to submit a new drug application 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 U.S.

Our second most advanced program is suprachoroidal CLS-TA used together with an intravitreal administered anti-VEGF agent for the treatment of macular edema associated with RVO or Retinal Vein Occlusion.

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 an intravitreal anti-VEGF alone in newly diagnosed RVO patients.

Ideally, we would like to see better visual outcomes in the early stages of the disease and if we achieve that we have a better opportunity to preserve vision over a longer term.

As RVO is one of the most aggressive retinal vascular diseases that can lead to vision impairment and potential permanent vision loss there is a strong need to develop new treatment approaches that provide rapid, effective, and more durable than currently approved therapies.

To that end, we are continuing to roll patients in our first of two RVO Phase 3 clinical trials called SAPPHIRE, which we initiated in the first quarter of 2017. SAPPHIRE is looking at Suprachoroidal CLS-TA used in combinations with the anti-VEGF agent Eylea.

Based on patient enrollment progressing today, we expect to report preliminary data from SAPPHIRE trial in the fourth quarter of 2018. Last week, we also announced enrollment of our first Phase and the second Phase 3 clinical trial called TOPAZ of suprachoroidal CLS-TA used with an intravitreal anti-VEGF agent in patients with RVO.

The design of TOPAZ is similar to SAPPHIRE. However [Technical Difficulty] [Operator Instructions] Our discussion, where we were talking about the TOPAZ trial, where last week announced enrollment of our first phase and second Phase 3 trial called TOPAZ of suprachoroidal CLS-TA used with an intravitreal anti-VEGF agent in patients with RVO.

The design of TOPAZ is similar to SAPPHIRE, however there is one key difference. In the second trial, we are looking at suprachoroidal CLS-TA used together with one of two different intravitreal anti-VEGF agents, Lucentis and Avastin.

As the primary endpoints were met with both SAPPHIRE and TOPAZ, we intend to seek a class label in the United States, which would if included as part of the market authorization and approval by the FDA allow suprachoroidal CLS-TA to be used together with any anti-VEGF agent for the treatment of RVO.

Our work in RVO in-part also laid the ground work for us to expand our development programs for CLS-TA to include another retinal vascular disease condition called Diabetic Macular Edema or DME. DME is the most common cause of visual loss in people with diabetes mellitus.

It effects up to 30% of people who have had diabetes for 20 years or more, and if untreated, approximately 20% to 30% of these patients will experience visual loss.

While the current standard of care in treating patients with DME is thought to use of intravitreal anti-VEGF agents, there is still substantial unmet need in this large patient population.

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

We believe that suprachoroidal CLS-TA used together with an intravitreal anti-VEGF agent has the potential to improve treatment 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 DME.

In the second quarter of 2017, we announced the completion of enrolment of an exploratory open label multicentered Phase 1, 2 Study called the HULK study of suprachoroidal CLS-TA both with and without intravitreal Eylea for the treatment of DME.

As Glen will discuss, the preliminary findings from the study, which were announced at AAO this past November were encouraging. At Q4, we also completed patient enrolment of TYBEE trial, a controlled randomized, masked, Phase 2 clinical trial of CLS-TA used together with Eylea in patients who are naive to treatment for their DME.

The completion of patient enrollment in TYBEE trial represents an important milestone and a step toward our DME clinical development program. We expect to release preliminary data from the TYBEE trial in the second quarter of 2018.

Recently, Clearside also received its 15th patent allowance in the United States protecting our proprietary model of SCS injection to treat ocular disease. This particular allowance relates specifically to the use of suprachoroidal CLS-TA on inflammatory agent together with an anti-VEGF agent.

And as we continue to advance our later stage development program for suprachoroidal CLS-TA in RVO and DME it is important to ensure that the potential market opportunities represent are well protective.

It is also important to note that given the awareness of our suprachoroidal approach as potential treatment to eye diseases and outcomes from our clinical trials, the investigators in all of our clinical programs continue to be very supportive and to date over 450 patients have undergone more than 650 suprachoroidal injections without any treatment related serious adverse events, including from this procedure.

I’ll now turn the call over to our CFO, Glen to provide more details on the PEACHTREE topline results in uveitis and our programs in RVO and DME.

Glen?.

Thank you, Daniel. As most of you know we held a separate conference call last week to discuss the PEACHTREE trial top-line results. So rather than repeating all the information, I will provide a summary of the details to focus our discussion. PEACHTREE enrolled 160 uveitis patients across 64 research sites in the U.S., India, and Israel.

Patients were randomized to received two suprachoroidal CLS-TA injections of two sham procedures 12-weeks apart.

The primary efficacy outcome measure was the proportion of patients with a change from baseline of at least 15 letters or three lines in best corrected visual acuity as measured by the early treatment of diabetic retinopathy study scale at 24-weeks.

Safety was assessed by analyzing the occurrence of adverse events, and changes in key safety parameters over the course of the trial. Additional safety and efficacy endpoints were also evaluated. As Daniel mentioned, the trial met its primary endpoint.

In PEACHTREE, 47% of patients received suprachoroidal CLS-TA every 12 weeks, gained at least 15 ETDRS letters in best corrected visual acuity from baseline as measured at week 24, compared to 16% of patients who underwent sham procedures every 12 weeks. This improvement was statistically significant with a P value less than 0.001.

In terms of improvements in BCVA, the mean change on baseline was better than the treatment on than in the sham on each monthly evaluation.

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

These improvements in mean changes in BCVA 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 CLS-TA 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 with no treatments related to serious adverse events reported in the trial.

97% of patients completed the trial through 24-weeks steroid related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA treatment group, compared to no patients in the sham group.

We are continuing to evaluate a subgroup of the trial subject, under a separate protocol for an additional six months to understand the durability of the effect. Let us turn our attention to our RVO program. As Dan has detailed, in addition to our use of suprachoroidal CLS-TA as monotherapy patients with uveitis.

In RVO, we are exploring with suprachoroidal CLS-TA along with an intravitreal anti-VEGF agent as a combination and provide improved visual acuity, reduce macular edema, and reduced treatment frequency as compared to administration of intravitreal anti-VEGF agents alone.

The medical literature provides evidence that corticosteroids and anti-VEGF agents each have known advantages in treating RVO when used intravitreal.

Our first randomized controlled double max, multi-center, multi country Phase 3 clinical trials with the potential treatment of patients with RVO called SAPPHIRE is being conducted at approximately 150 investigational sites across approximately 18 countries.

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

The primary objective of the year-long SAPPHIRE trial is to determine the proportion of patients in each arm with an improvement in BCVA of more than not equal to 15 letters on baseline at eight weeks after the initial treatment.

As a point of reference, in the previously reported TANZANITE Phase 2 trial and treatment naive patients with RVO, where additional treatments were on an as needed basis after initial randomization, 61% of patients would receive the suprachoroidal injection of CLS-TA along with an intravitreal injection of Eylea at baseline achieved a greater than or equal to 15 letter improvement in BCVA at eight weeks.

While 39% of patients had received only an intravitreal injection of Eylea baseline showed a 15-letter improvement in visual acuity at eight weeks.

Further, in TANZANITE trial, improvements in visual acuity and Macular Edema seen at month one at the combination with suprachoroidal CLS-TA and intravitreal Eylea were maintained with an aggregate of 60% fewer additional Eylea treatments compared to improvements seen from the monotherapy Eylea through the three months observation period of the trial.

This result was statistically significant with a P value of 0.013. As Daniel also mention and announced in our press release last week, we are now enrolling patients in our second Phase 3 trial TOPAZ.

Topaz is a multi-center randomized mass-controlled trial to safety and efficacy of suprachoroidal CLS-TA used together with one of two intravitreal anti-VEGF agents Lucentis ranibizumab and Avastin or bevacizumab in treatment naïve patients with Retinal Vein Occlusion The design of the second Phase 3 trial is similar to that of the first Phase 3 SAPPHIRE trial.

Patients in the combination on the trial will receive suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent at the beginning of the trial and intravitreal anti-VEGF agents along the week four 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 through week 24. After 24 weeks, patients in each arm will be followed for approximately an additional six months.

The primary objective of the trial will be to determine the proportion of patients in each arm with the best corrected visual acuity, improvement of 15 letter or more from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated.

We anticipate total enrolment of approximately 460 patients in the second Phase 3 trial. I now want to turn our attention to the other major retinal vascular condition we are seeking to treat, diabetic macular edema or DME in which we have our third clinical program.

In our DME program, we have completed a Phase 1, 2 clinical trial; the HULK trial where patient enrolment was completed in April last year and preliminary results were reported in the fourth quarter of 2017. In this trial, we evaluated suprachoroidal CLS-TA with or without intravitreal Eylea and patients with DME.

While safety was the primary outcome in this study, we also evaluated changes in best corrected visual acuity and in macular edema over the six-month evaluation period. Initial safety results suggest that CLS-TA was generally well tolerated.

Further, they were encouraging efficacy signals in terms of visual and anatomical improvements with a trend towards durability particularly in the combination treatment on. In November, during the Retina Subspecialty Day of the American Academy of Ophthalmology Dr.

Charlie Wykoff presented preliminary data from HULK, which showed anatomical improvement was observed in all treated eye 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 retreatment for the entire six months with an additional 20% requiring only one retreatment.

Suprachoroidal CLS-TA, including in patients who received as many as five injections was well tolerated with a low incidence of ocular side effect, including adverse events associated with elevated intraocular pressure.

In October 2017, we announced the completion of patient enrolment in a multi-center randomized mass-controlled Phase 2 trial named TYBEE to evaluate suprachoroidal CLS-TA along with intravitreal Eylea compared with intravitreal Eylea along in patients with DME over a six-month evaluation period.

In this Phase 2 trial patients with DME randomly assigned 1:1 through a combination of suprachoroidal CLS-TA and intravitreal Eylea or drove controlled monotherapy on with only intravitreal Eylea. The trial will have a fixed treatment portion for the first three months followed by an as needed portion.

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

Patients follow-up in the TYBEE trial is six months and we expect to announce preliminary data in the second quarter of 2018. Our developmental teams had a busy and productive 2017 and we appreciate all of their efforts.

I’ll now turn the call over to our Chief Financial Officer, Charlie Deignan to review our fourth quarter and full-year 2017 financial results.

Charlie?.

Thanks Glen. As we reported this morning, our research and development expenses were $14 million for the fourth quarter 2017, compared to $7 million for the same period in 2016. As we mentioned on our third quarter call, we had an increase in R&D costs associated with our clinical development programs in uveitis, RVO, and DME, which was expected.

And as Daniel and Glen highlighted in their opening remarks today, we have been advancing our development programs with the reporting of topline data from our Phase 3 trial for macular edema associated with non-infectious uveitis last week.

The continuing enrolment of our patients in our Phase 3 trials for RVO and the completion of both Phase 1, 2 and Phase 2 trials for DME in April 2017 and October 2017 respectively. General and administrative expenses in the fourth quarter of 2017 were $2.4 million, unchanged from the same quarter with 2016.

The fourth quarter 2017 net loss was $16.5 million or $0.65 per share, compared to $9.7 million or $0.45 per share for the same period in 2016. Cash used in operating activities for 2017 fourth quarter was approximately $15 million. At December 31, 2017 cash, cash equivalents and short-term investments totaled $37.6 million.

Earlier this week, we completed a public offering in which we raised gross proceeds of $85 million.

With the net proceeds of approximately $18 million from the transaction after deducting underwriting discounts and commissions in estimated operating expenses, we believe that sufficient cash on hand to fund operations and begin commercialization activities as Dan said the potential launch of our first products.

Our goal is to report our RVO Phase 3 data before the end of this year and we expect to have approximately the years of cash remaining after that. And with that, I’ll 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 to Clearside's strategy. As Charlie mentioned, our recent public offering should fund the company's operations, due to potential commercialization of our lead product candidate.

I’m very pleased that Clearside's strategy continues to demonstrate the greater utility of treating complex, sight-threatening eye diseases using a unique drug distribution provided by suprachoroidal delivery.

The observations made in our nonclinical models have now been well reflected and powerful topline pivotal data for suprachoroidal CLS-TA uveitis. In the future, if the Phase 3 clinical trials we are conducting or planning to conduct in RVO and DME Phases meet their primary endpoints, the market authorizations are obtained.

This drug may have wider accessibility than other potential treatments. We have built and will continue to build and accomplish a driven management team to support Clearside's development of drug, retinal and choroidal diseases, and establishment of strong commercial infrastructure in the United States.

In that regard, before concluding, I want to take this opportunity to highlight a couple of management changes announced just ahead of the PEACHTREE data that were designed to help support our transition to a commercialized company if we obtain FDA approval in our first indication.

Bill Humphrey, the director since 2012, was appointed Chairman of Clearside board. Also, Brion Raymond who is here with us today to help answer your questions was hired into the newly created position of Chief Commercial Officer. Brion brings a tremendous amount of relevant ophthalmic experience and retinal specialist relationships to Clearside.

He was a key member of the team at Genentech responsible for launching Lucentis, a blockbuster ophthalmic drug. Brion will be focused on the development and execution of a comprehensive commercial strategy for Clearside’s pipeline of treatments targeting sight-threatening diseases if approved by the FDA.

I’m excited that we were able to attract and executive of his caliber to Clearside at this important time. This concludes our prepared remarks for the day. Before I open the call to questions, I’d like to express my thanks to the entire Clearside team for the significant progress we’ve made throughout last year, and so far into the first quarter.

We have a strong highly capable team of professionals that are consistently delivered on our key goals, and we appreciate their commitment to our mission. With that, we will now open the call for questions.

Operator?.

Hi guys. This is [indiscernible] in for Anupam this morning. Thank you for taking our questions and congratulations on the year-end update here.

I guess from us, looking out towards the TYBEE top line and read-out and DME coming up soon here in 2Q, wondering what the Phase 2 trial is powered to show on visual acuity and what is assumed for visual acuity gain in the control arm? What will be the other key secondary endpoints to monitor and is there any part of this data set that we will have to wait for later in the year? Thanks guys..

Thank you Tesa [ph] for your question. I’m going to ask Glen Noronha, our Chief Scientific Officer to take that one..

Thank you, Daniel. And thank you for the questions. So, TYBEE is powered to look at the mean change in best corrected visual acuity and we will be looking at the confidence intervals between the two arms in there.

Now, in terms of what you normally see in Eylea at six months, those data are available and they are prescribing information, but from all the studies that you look at the data between 8 and 12 letters gain depending on the study, it’s usually at that these 10 letters that you will see with Eylea.

With regard to, what are the other key pieces of information to look at? We will look at the proportion of patients gaining various levels of improvement, including those who gained nothing, those who gained five letters, 10 letters, 15 letters, we look at mean changes in central subfield thickness, we look at the percentage change in excess retinal thickness.

These are all meaningful in terms of clinical outcomes.

We will also look at the number of additional Eylea injections that are given in each arm throughout the course of the study as well as in week 12 onwards, and we look at all the key safety parameters that include all the key items that we usually look at within the framework of clinical trials in our technology.

It is normal for us to look at preliminary data that come out initially and then over the course of the next several weeks to get the complete dataset. And we will present as best all the data that we can at an upcoming medical conference in the shortest time possible where we could get an abstract and presentation up..

Okay great. Thanks for taking our questions..

Thank you. Our next question comes from Annabel Samimy with Stifel. Sorry, if I mispronounced that. Your line is open..

Hello, hi guys. Thanks for taking my questions.

On the DME trial, just when you were describing DME you had mentioned that there are complications to do multiple pathways, so is there any reason to believe that a DME patient may respond differently than say the RVO patient, the uveitis patient, is there anything that you are concerned about or any kind of difference in change that you would expect, but it is still acceptable in this patient population? And then in the RVO study, I understand that you are administering CLS-TA at our regular schedule with anti-VEGF treatment, I know at one point you were discussing or you were in the pharmacoeconomic argument was that you could potentially extend the time you make anti-VEGF more on a parental basis or like on an as needed basis.

So, is there anything and any other trials that might provide that kind of color as you put the package together for NDA filing? Thanks..

Annabel, thank you, and good talking to you. Thanks for your question. So, I’m going to just touch on one part of this, and I'm going to hand it over to Glen. All of these complex retinal diseases are multifactorial.

And as with DME, it does have multifactorial, may be slightly different than - different than we would expect out of Retinal Vein Occlusion or uveitis, but uveitis as well as multifactorial, and so when we saw the results from the PEACHTREE data we were very encouraged on how this might look in other diseases, as well as steroids if it is going to be effective in diabetic macular edema.

Glen, maybe you want to comment on the other side of the question, I think with….

Certainly. So, to add to what Daniel said, DME and RVO are clearly different diseases and we will be expecting to see what our outcomes look like and once we have the data we will be able to address better what we are going to find.

The other part that you had asked was how we can determine in our Phase 3 trial and whether we have measures that will help us to know what the Pharmacoeconomics look like? So, we have designed our trial in such a way that we have got quarterly treatment treatments and we have our we will use the data that we get from our Phase 3 assuming we meet our primary endpoints in order to make the appropriate arguments because it will be a change in the frequency of treatment, the kinds of agents that are used, all those data put together where you have a team that’s looking into this and building the right models and they use these data as in order to help to refine those models and make those arguments..

Okay. Great. Thank you..

Thank you. Our next question comes from Liana Moussatos with Wedbush. Your line is open..

Again, congratulations on your progress and great data.

What are the steps to submitting an NDA in Q4 for NIU?.

Thanks Liana. So, first of all, I will touch on that and then hand it over to Glen again to see if he has any more color to it. But, we have had several meetings with the FDA regarding macular edema for non-infectious uveitis and given the nature of TANZANITE and what we know about TANZANITE they have allowed us to do a single study.

So that’s all the clinical pivotal clinical work we will need to do to support the overall cloud [ph]. We are continuing to follow some of these patients to look at the durability of treatment. I think Glen made that point in his comments. And then of course the other side of this picture is how can we make this.

We have been actively engaged in the manufacturing of both the drug, as well as the microinjector for this purpose of trying to file and NDA by the end of this year.

Glen, you may want to add some more color to this, if you have any thoughts?.

Thank you, Daniel. All our preparations are underway and it’s our intention to file in the fourth quarter and we have everything that is being put in place and ongoing currently in order to meet that expectation..

And what’s going to be your capacity for manufacturing the drug in the microinjector?.

Thank you, Liana for that question. So, we have designed this to manage all of our - to manage all the way up into peak sales. We’re going to start early on, we will have plenty of capacity ahead of the launch in the first few years and see whether there is a product in terms of demand, and we will have plenty of support there.

But both the microinjector as well as the drug, which we are actually manufactured at different locations..

Thank you, very much for taking my questions..

Great, thank you..

Thank you. Our next question comes from Serge Belanger with Needham. Your line is now open..

Hi good morning. Firstly, a question on the uveitis program, then we have discussed potential regulatory filings outside the U.S.

and you just described, I guess what kind of conversations you’ve had with these regulatory agencies and whether we should expect some kind of partnership in the near future to go forward with these regulatory filings?.

Thanks, Serge. Thanks for the question. We are just now receiving the topline data in the United States and we tried a thorough conversations with the FDA about what is required here for a product approval. We are continuing to put this altogether into a fact to file about in the fourth quarter as we just mentioned.

We’ve also laid out plans for other territories outside the United States that we’re going to start to execute upon. We, as with any case, you might expect when you have powerful topline data like this that there are always discussions ongoing with outside companies that would be interested in this product as part of their portfolios.

And on an international basis, we fully intend either to partner this product out or to work with well-known distributors that we run into throughout our careers of both the distribution of the product.

So right now, we are just gathering and characterizing United States, initially states focused on that and then we're going to be continuing to evaluate and we have already laid out our plans for taking to areas outside of the United States..

Okay.

And then just thinking of the RVO Phase 3 program in terms of SAPPHIRE and TOPAZ, it looks like SAPPHIRE from start to finish will take just a little less than 24 months, TOPAZ given that you will be evaluating treatment with Lucentis, how do you think that will impact enrolment in that study?.

That’s a great question. I continue to be impressed by the interest in retina physicians for this particular indication. They are encouraging, they are thoughtful about the study. I can’t comment really on the rate of enrolment versus Sapphire. I know that Sapphire, the enrolment is going extremely well.

We have a six-month employee, or a follow-up we have a two-month primary endpoint that we’re focused on. So, with that in mind, we anticipate that TOPAZ is probably be about the same as SAPPHIRE. I don't want to kind of over set your expectations. However, there is a lot more information out there than then what we had started SAPPHIRE.

There is a lot more of data that in our uveitis trials, as well as further information from our Phase 2 TANZANITE study. So, as the information continues to come out on the programs and that we’re running. The feedback has been quite encouraging..

Okay.

And can you tell us about the make-up of the clinical sites we will be enrolling patients? Are they all U.S.-based or just where they are geographically?.

SAPPHIRE and TOPAZ are both global clinical studies. Designed to meet their regulatory requirements as a global product. And this is where we think globally as a company and we would like to see us continue to go through the process of executing these trials. It is on all continents, so both the U.S.

the two trials are up both U.S., Europe, Asia in Australia. So, it is a global network of clinical facilities that are working in Retinal Vein Occlusion..

Alright, thanks..

Great. Thank you, Serge..

Thank you. [Operator Instructions] Our next question comes from Donald Ellis with JMP Securities. Your line is now open..

Thank you, and good morning. I have two questions.

The first question is, are there any pathophysiology similarities between uveitis, DME, and RVO that might suggest that efficacy in uveitis would imply potential efficacy in DME and RVO? And then my second question is regarding adding Lucentis to Eylea trial, is the idea there that you might be able to get a class label in other words instead of just in combination with Eylea in combination with anti-VEGF? Thanks..

Thank you, Don. Let me just summarize maybe the common thread with all of these diseases is macular edema, and this is a target that we have been after. Why don't I have Glen comment on the pathophysiology more specifically, but the macular edema seems to translate across most of diseases..

Thank you, Daniel. So, I would be a little cautious in drawing comparisons between diseases. They are different diseases and we expect with each disease it is going to show its own outcome, and we will look at what the data show us, but I want to add to what Daniel said that’s really important. We are using agents that are unknown.

Corticosteroids have been shown to be effective for diabetic macular edema for Retinal Vein Occlusion, as well as for non-infectious uveitis. Anti-VEGF agents have been known to be effective, highly effective for Retinal Vein Occlusion and diabetic macular edema. We have a unique approach to the way we are looking at our treatment paradigm.

We are using our corticosteroids formulation CLS-TA suprachoroidal, and we hope to bring the advantages of the suprachoroidal approach to the treatment of these patients. And in both RVO and DME, we’re approaching using this combination where we have two modes of action that we're bringing into play. And let’s see what the results tell us.

With regard to the class label, we had discussions with the FDA and it is our objective based on our understanding of our discussions with them that if we are able to evaluate in Retinal Vein Occlusion, CLS-TA suprachoroidal in combination with multiple agents, there are three known agents, we are going to use all three agents.

I will ask use the first trial and Lucentis and Avastin are in the second trial that if each of these trials meets the primary endpoint, then we have the potential to look at a class label, which is to be able to use it with an anti-VEGF agent because we have tested CLS-TA with all three known anti-VEGF agents.

And our understanding is that, if we meet our primary endpoint, we could see that kind of approval in terms of the regulatory outcome to marketing authorization. So, you are correct. That’s the object or including the other two anti-VEGF agents in the second study.

So, the three taken together could be used to request that kind of an outcome from - in terms of marketing authorization. Clearly, the FDA has the say in this, but our agreement has been with them in terms of discussion that this will be the case..

Great. Thank you..

You're welcome..

Thank you. I’m showing no further questions in queue. So, I’d like to turn the conference back over to Mr. White for closing remarks..

Thank you once again for joining us in 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 that does conclude today's conference. Thank you for your participation. You may all disconnect and have a wonderful day..