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

Nick Rubino - Stifel Serge Belanger - Needham Liana Moussatos - Wedbush.

Good day, ladies and gentlemen and welcome to the Q2 2018 Clearside Biomedical 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 follow at that time. [Operator Instructions] I would now like to introduce your host for today’s conference, Mr.

Steve Kilmer of Investor Relations. Sir, you may begin..

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 for the year ended September 31, 2017 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 an update on our commercial organization as we approach our near-term market opportunity in non-infectious uveitis, Glen will then take you through the details of our clinical development programs, and Charlie will discuss our financial results, and finally I will summarize our discussions.

We will then have time at the end of the call for some Q&A. The positive top line data from PEACHTREE marked a potential inflection point for Clearside and it could help pave the way for a transition from a clinical phase to a commercial stage company.

To help lead the transition, we recruited Brion Raymond as our Chief Commercial Officer early in 2018. Brion brings a tremendous amount of relevant ophthalmic experience and retina specialist relationships to Clearside. [indiscernible] Carol Hoang who joined just a few weeks ago as Vice President of Medical Affairs.

[indiscernible] other past accomplishments of the key members of the team at Genentech responsible for launching the widely used Lucentis. In a few moments, Brion will provide more details on the attractive uveitis market opportunity. We made significant progress this past quarter in advancing our pipeline.

In that regard, 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, suprachoroidal injected CLS-TA, a proprietary suspension formulation of the corticosteroid triamcinolone acetonide, is being evaluated either alone or in combination with an anti-VEGF agent as potential treatment for sight threatening diseases of the retina or the choroid.

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.

As I mentioned, we announced positive top line results from our Phase 3 pivotal PEACHTREE trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis in March.

The PEACHTREE trial met its primary endpoint, a statistically significant improvement in the proportion of patients getting 15 letters or more in visual acuity as measured on the early treatment diabetic retinopathy study scale. We may refer to that as ETDRS. All key secondary endpoints in the trial were also achieved.

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. In addition, while we are in discussions with regulatory agencies in Europe and other jurisdictions, we intend to receive marketing authorizations outside of the US.

While suprachoroidal CLS-TA is being studied as a monotherapy in patients with macular edema associated with non-infectious uveitis, Clearside is also studying suprachoroidal CLS-TA together with an intravitreal anti-VEGF agent in two other retinal vascular diseases, retinal vein occlusion or RVO and diabetic macular edema, or DME, both of which have a high vascular endothelial growth factor response to their diseases.

RVO is a particularly aggressive eye disease resulting from an occlusion in a vein carrying blood out of the retina. This blockage can lead to rapid onset of complications, such as sudden declines in vision.

Accordingly there is a significant need to develop new treatment approaches that are both effective early on and that are more durable than current approved therapies.

To that end, our objective of our Phase 3 RVO Program is to demonstrate suprachoroidal CLS-TA used together with an intravitreal anti-VEGF agent like the currently marketed drug, EYLEA, can result in better visual outcomes in the early phase of the disease than treatment with an intravitreal anti-VEGF agent alone.

This is what we saw in our Phase 3 [indiscernible] trial, where 52% of the patients receiving combination treatment recovered three lines of vision by month one compared to 39% receiving EYLEA alone. In June, we announced completion of patient enrollment of our first of two Phase 3 clinical trials at RVO, called SAPPHIRE.

SAPPHIRE evaluated suprachoroidal CLS-TA used in combination with EYLEA in treatment naïve patients with RVO.

If we achieve similar results in SAPPHIRE to that we saw in the [indiscernible] trial, we believe that this trial has the potential to demonstrate the ability of suprachoroidal CLS-TA to lead to recovered vision earlier, and potentially preserve those vision gains over the long-term.

We look forward to reporting top line 8-week primary endpoint data from the Phase 3 SAPPHIRE trial in the fourth quarter of 2018. In March, we also announced enrolment of first patient in TOPAZ, a second Phase 3 clinical trial of suprachoroidal CLS-TA used with intravitreal anti-VEGF agents in patients with RVO.

The design of TOPAZ is similar to SAPPHIRE with one key difference. In the second trial, we are evaluating suprachoroidal injected CLS-TA used together with one of two different intravitreal anti-VEGF agents either LUCENTIS or AVASTIN.

If the primary endpoints are met in both SAPPHIRE and TOPAZ trials, we intend to seek a class label in the United States, which is included as part of the marketing authorization approved by the FDA to allow suprachoroidal CLS-TA to be used together with any anti-VEGF agent for the treatment of retinal vein occlusion.

In addition, based on recent feedback from the European Medicines Agency we believe that data from the RVO phase 3 development program should be sufficient to support potential Marketing Authorization Application in the EU.

Our work in RVO in part also laid the groundwork for us to extend the development program for CLS-TA to include another retinovascular condition with a large population DME. DME is the most common cause of visual loss of people with diabetic mellitus. A consequence of diabetic retinopathy, DME is swelling in the retina caused by leaking blood vessels.

DME affects up to 30% of people who have had diabetes for 20 years or more and if untreated approximately 20% to 30% of people who have it will experience moderate vision loss.

In May, we announced positive top line data from TYBEE, our multicenter, randomized, masked controlled Phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal CLS-TA used with intravitreal Eylea in 71 patients with DME over a 6-month evaluation period.

The question we are most interested in understanding from this exploratory trial was whether vision needs to be maintained with fewer treatments. So monthly injections are imposed as a significant treatment burden on patients with DME.

In the TYBEE trial, we observed not only statistically similar visual results in every time point in patients treated less frequently with a combination treatment as compared to those treated monthly with EYLEA alone, and we also observed significant improvement in resolution of retinal fitness by month one after the treatment with suprachoroidal CLS-TA.

We believe CLS-TA use of anti-VEGF agents has the potential to provide a more lasting response to treatment thereby substantially lowering the treatment frequency and burden for DME patients. In a few moments, Glen Noronha will provide more details on the TYBEE results.

But before he does, 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. The global uveitis market is expected to reach over $1 billion by 2024 and in the United States affects approximately 350,000 patients.

Macular edema occurs in approximately one-third of these patients, and is the largest contributor to vision loss. Suprachoroidal CLS-TA if approved by the FDA for the treatment of macular edema associated with non-infectious uveitis would be the first therapy indicated for this disease and represents an attractive market entrance opportunity.

Over the past two quarters, we have made great progress building our commercial team to capitalize on this opportunity. Our team has decades of experience in ophthalmology and broad relationships within the retina and uveitis communities.

Our commercial team leaders built their expertise at companies such as Genentech, [indiscernible] EyeTech and OptoTech and have executed new product launches across all commercial areas, including marketing, access and reimbursement, market analytics and sales.

We are confident if the FDA approves suprachoroidal CLS-TA that we will be ready to rapidly and efficiently reach the uveitis and retina specialists who manage these patients in the United States.

I will now turn the call over to our Chief Scientific Officer, Glen Noronha, to provide some additional details on the PEACHTREE data as well as the TYBEE results in DME and on our programs in RVO as well.

Glen?.

Thank you, Brion. As we have discussed the PEACHTREE top line results on previous calls, I will provide a brief summary of the data to focus this discussion. PEACHTREE enrolled 160 uveitis patients across 64 clinical research sites in the US, India and Israel.

Patients were randomized 3 to 2 to receive two suprachoroidal CLS-TA injections or two sham procedures 12-weeks apart with 96 and 64 patients randomized in each arm respectively. As Daniel mentioned, this trial met its primary endpoint.

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

For a key secondary endpoint, administration of a suprachoroidal CLS-TA resulted in a mean reduction from baseline of 153 microns in central subfield thickness at week 24 in the CLS-TA arm compared to 18 micron mean reduction in the sham arm, a result that was also statistically significant with a P value less than 0.001.

Suprachoroidal CLS-TA was generally well tolerated with no treatment related serious adverse events in the trial. 97% of patients completed this trial. As we have continued to analyze the data some key positive observations include the following.

Approximately two thirds of the patients in the CLS-TA arm, who had any level of inflammation at baseline showed resolution with scores of zero in each of the three commonly used signs of inflammation in the eye, namely anterior chamber cells, anterior chamber flare or vitreous haze.

In all three of these signs of inflammation, there was significant improvement in resolution of uveitis when comparing the CLS-TA arm to the control arm at week 24. More recently, during an oral presentation at the 2018 American Society of Retina Specialists annual meeting in Vancouver held recently, Dr. Steven Yeh, with the Louise M.

Simpson Ophthalmology and Uveitis and Vitreoretinal Surgery Director in the Uveitis and Vasculitis Service at the Emory Eye Center at Emory University, shared data from PEACHTREE, which provide further support for suprachoroidal CLS-TA as a potential treatment option for macular edema associated non-infectious uveitis.

One such analysis pointed to the functional significance of the vision improvements observed in the PEACHTREE trial. Specifically, 52% of patients in the CLS-TA arm could read 70 or more ETDRS letters at week 24, which is the legal requirement for driving in most states compared to 22% of patients in the control arm.

Also based on further safety analysis, which now includes patients who received rescue therapy elevated intraocular pressure adverse events pertaining to corticosteroid use were reported for 11.5%.

That is 11 out of 96 patients in the CLS-TA arm compared to 26.3%, 10 out of 38 patients in the control arm who were rescued with local corticosteroids, such as intravitreal OZURDEX and subtenon and intravitreal triamcinolone acetonide resulting in an overall elevated intraocular pressure of 15.6% of patients in the sham control arm through 24 weeks, regardless of whether or not these patients received rescue therapy.

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

We also plan to pursue marketing organizations outside the United States. Let us turn our attention to our RVO program.

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

The literature provides evidence that corticosteroids and anti-VEGF agents each have known advantages in the management of RVO, when used intravitreally. In mid-June, we completed patient enrolment in our first randomized controlled, double masked, multicenter, multi-country phase 3 clinical trial for the potential treatment of patients with RVO.

The trial is called SAPPHIRE. This trial had enrolled 460 patients at approximately 150 investigational sites across 18 countries. Patients in SAPPHIRE are being randomized to either a combination arm, in which they receive suprachoroidal CLS-TA along with intravitreal Eylea, or to a control arm in which patients receive intravitreal Eylea alone.

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

The primary endpoint in the SAPPHIRE trial is to determine the clinically meaningful proportion of patients in each arm with an ETDRS improvement of 15 or more letters from baseline eight weeks after initial treatment. We expect to report top line data from SAPPHIRE in the fourth quarter of 2018.

As Daniel also mentioned, we are now enrolling patients in our second Phase 3 RVO trial TOPAZ, the design and scale of which are similar to SAPPHIRE, but which is evaluating suprachoroidal CLS-TA in combination with one of two other intravitreal anti-VEGF agents Lucentis or Avastin in treatment naïve patients with RVO.

I now want to turn our attention to the other major retinovascular condition we are seeking to treat, diabetic macular edema.

In May 2018, we completed a Phase 2 clinical trial, which we refer to as TYBEE, evaluating the safety and efficacy of administering a combination of intravitreal EYLEA in suprachoroidal CLS-TA to patients with DME as compared to intravitreal EYLEA alone.

71 patients were randomly assigned one to one receiving the quarterly treatments of suprachoroidal CLS-TA together with the intravitreal Eylea at month zero and three in the combination on or four monthly treatments of intravitreal Eylea at months zero, one, two, and three in the control arm with patients in both arms to saving intravitreal Eylea treatments at months four and five as needed, patient follow-up anti-VEGF with six months after initial randomization.

The TYBEE trial met its primary endpoint. In each arm of the trial that it is statistically significant been improvement in best corrected visual acuity from baseline over six months with a P-value of 0.001.

These improvements in best corrected visual acuity in each arm where clinically and statistically similar with a combination arm and the Eylea arm gaining 12.3 and 15.5 [ETDRS] letters respectively with a P-value that showed that these two numbers are not different from each other.

Additionally administration of suprachoroidal CLS-TA together with intravitreal Eylea made a key secondary endpoint with the mean reduction from baseline of 208 microns in central subfield thickness of the active arm six months compared to 177 micron mean introduction in the Eylea alone arm with a P-value of 0.156.

There was significantly better resolution of edema in the combination on as compared to the control arm at week four with the P-value less than 0.01. As we summarize in a table included in our press release this morning, the additional CLS-TA reduction of the combination arm was observed at week four and was sustained through the end of the trial.

Suprachoroidal CLS-TA in combination with intravitreal Eylea was gently well tolerated with no treatment related serious adverse events reported in this trial through the 24 week evaluation period. Elevated IOP adverse events were reported for 8.3% or 3 out of 36 patients in the combination arm compared to 2.9% one out of 35 in the control arm.

Both combination control arms reported cataract adverse events with approximately 5.6%, two out of 36 patients in the combination arm and 2.9% or one of 35 patients in the control arm.

As we receive the individual patient data, we will continue to work closely with our scientific and medical advisers to evaluate the outcomes of the TYBEE trial and to develop a path forward to this important program. As you can see the development teams have had a billion productive second quarter and we really appreciate all of their efforts.

And I will now turn call over to our chief financial officer Charlie Deignan to review our second quarter 2018 financial results.

Charlie?.

Thanks Glen. As we reported this morning our research and development expenses were 17.3 million for Q2 2018 compared to $11.5 million for the same period in 2017.

As expected we had an increase in our R&D costs associated with our clinical development programs and R&D and RVO, and DME, partially offset by decrease in costs associated with our uveitis program as PEACHTREE was 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 noninfectious uveitis in March from our Phase 2 trial for DME and to continuing Phase 3 trials for RVO.

General and administrative expenses in the second quarter were $3.6 million, up from $2.3 million in the 2017 second quarter. This increase was primarily due to higher employer related cost and marketing expenditures to support the potential commercialization of CLS-TA.

The Q2 2018 net loss was $20.7 million or $0.65 per share, compared to $13.8 million or $0.54 per share for the same period in 2017. Cash used in operating activities were - in the 2018 second quarter was approximately $19.5 million. As of June 30, 2018 cash, cash equivalents and short-term investments totaled $84.4 million.

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

As Daniel and Glen mentioned our goal is to report data from the first Phase 3 SAPPHIRE trial in RVO before the end of the year and we expect to have enough cash to take 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 a greater utility in treating complex, sight-threatening eye diseases using the unique drug distribution provided by suprachoroidal delivery.

To summarize we make great progress for this year and advancing our pipeline including reporting positive results from our Phase 2 trial and uveitis and meeting the primary endpoint in our Phase 2 TYBEE trial and DME.

Moving forward, we are on track for our key milestones in the second half of the year including our first in the NDA filing, the release of top-line Phase 2 SAPPHIRE related in our view. This concludes our prepared remarks for today.

Before I open the call for questions, I would like to express my thanks to the entire Clearside team for the significant progress we’ve made in the second quarter. We have a strong and have capable team of professionals and they consistently deliver on our key goals and we appreciate their commitments to our mission.

With that, we will now open the call up for questions, operator?.

[Operator Instructions] And, our first question comes from the line of Anupam Rama from JPMorgan. Your line is now open..

Hi guys. This is Tess on for Anupam this morning. Thank you for the updates here and for taking our questions.

One from us maybe on any further physician feedback you all have gotten following TYBEE around BCVA, CSP additional Eylea injections required and maybe also safety in the context of the unmet need in the disease here? And then secondarily, what are the outstanding endpoints to monitor and the total data set that will inform the design for the pivotal trial? And then related if I could, can you comment on the extent of the [re-drill] from DME that you anticipate, so RVO expected now in 4Q? Thanks so much, guys.

.

Let me maybe answer your last question first. So, there's and then I'll turn over to Glen to kind of talk about some of the physician feedback upon.

There is a big difference between patients who have diabetes, who may have had diabetic retinopathy for a long period of time and then they're finally seeing their central vision begin to be affected and that creates diabetic macular edema will set for vision and this is the field in which we really pay attention to you because that's where vision loss is occurring.

A big difference in that compared to RVO is that RVO is catastrophic vision loss, where you see occlusion causing or more like a stroke on your retina and that is causing just a huge amount of VEGF to be produced and you see really good outcomes because you see these very-very large changes in people's vision with RVO.

So, that's some of the hallmarks if you intend to think about. Corticosteroids have been known to work in DME. And we see a couple of approvals out there, but we want to find the right place and right occasions in our evaluation of the TYBEE data.

The one thing that we've been hearing from physicians consistently is they're very impressed by us with we are able to improve central retinal thickness in the patients. They do understand it's a bit tougher patient population, but we do hear that comment consistently.

And as far as the side effects, they see those side effects consistent with natural history of the patient population and also that we could see that it's consistent with our other trials where we see this very low event of our intraocular pressure compared to what we would expect in the literature and we're also seeing now comparing sham control of PEACHTREE, another there's been control the topical drop.

So, we're happy about that. Glen why don't I turn it to you about kind of where we stand on the day evaluation and what are some of the next steps we think about..

Thank you, Daniel. So, I want to highlight the fact that DME is unique disease all by itself and we are continuing to analyze data. We are focusing in on all the information that we have as well as the information to come.

We have clearly found that the anatomical information is providing some unique outcomes including the fact that we have a statistically significant resolution that occurs at month one with a P-value less than 0.01.

And, these anatomical outcomes that are achieved with a lower frequency of treatment key to some of the items that we'll be continuing to look at in greater detail. Clearly we match the visual acuity outcomes statistically and clinically that are seen for monthly intravitreal afilbercept Eylea.

And so as we continue to tune in on these data we'll be focusing in on frequently, the reduction of treatment burden, and as well as the anatomical outcomes, but we'll keep everybody informed through medical conferences and other information as we continue to find the key pieces of information that will help us to inform the program as it goes forward..

Hey Tess, this is Daniel again. The last physician feedback I've been receiving has been if you think about the everyday practice of DME that worst were one consistent complaint we have is that is around compliance where we see in many practices nearly 20% of patients don't return in a timely fashion for their second or third injection.

And, by under treating these types of patients, we're seeing real-world outcomes more like five letters of improvement and as you can see in our clinical trial we got 12.3..

Great. Thanks so much, Daniel. Thank you, Glen. I appreciate all the color guys and thanks for the updates..

And, our next question comes from the line of Annabel Samimy from Stifel. Your line is now open..

Good morning this is Nick Rubino on for Annabel Samimy. Thanks for taking our question. Starting to think about the competitive landscape in uveitis, there are other products and development with three-month implants or one month - or one year implant.

How might this impact your opportunity in uveitis?.

Thanks Nick. This is Daniel. I think its best that I’ll let Brion Raymond answer that as he's preparing for the launch and he will be comparing our data with what others are doing in the marketplace..

Sure. Thanks Daniel. I think there are a couple ways to answer that question. First is indication. Our indication is expected to be or the FDA approves that macular edema following non-infectious uveitis and its agnostic to the location of the uveitis.

And so two things there, one, we’ll be the only ones with that indication and we’ll also be the only ones that should we be approved would be reimbursed for all types of uveitis as long as they have macular edema.

So, we're going after the more severe patients and we're showing visual gains that I don't believe have been shown before with other drugs. Second is we're targeting first-line therapy.

If there's macular edema when the patient walks in the door we would like to be the first-line therapy for those patients to eliminate that edema and bring vision back to patients. So, I think we're just positioned differently in the marketplace and we hope to be first-line. We have some of the longer therapies are more than maintenance approach. .

Great. Yes. Thank you..

So Nick, this is Daniel. I just want to share something with you guys. This gets to me as a CEO vision company and hopefully all of our team thinks about it as well. I think there's like 2.7% of patients who came into that trial could see 20/40 or better that means they were driving. They have to have some assistance making it to the clinic.

They have to bring it back to how they're going to make it to do next visit.

And then by the end of trial even by that there are about 53% of patients receiving 20/40 or better and that means they're walking to their house and they're doing the day-to-day tasks that we wanted it maybe even driving and these are the things that help us kind of wake up every morning and come to work.

So I think PEACHTREE going after being the first company to go after the best record visual endpoint as a target in this particular disease and that becoming a very meaningful outcome. And, I think the physician feedback we're getting off that is that we are managing the patients well, we’re meeting the best corrected visual acuity.

And, in most cases that we are - that two thirds of the patients are seeing resolution of their signs of Eylea, they said all compartments of the disease and that's exciting because it's really, really playing a role in the disease..

Great. Yes. Thanks for the additional color..

And, our next question comes from the line of Serge Belanger from Needham. Your line is now open..

Hey, good morning. A couple questions for me on uveitis. It sounds like your Ex-U.S. Strategy is being developed here. I just wanted to hear your thoughts on what you're thinking in terms of filing and partnering for commercialization? And, then I guess can you just talk about the market opportunity in uveitis for - in Europe as well as other U.S.

- ex-U.S.

Territories?.

So, yes, thanks. Serge, I mean we can - when I think about any product that we want to develop we consider this as a global approach. When you look at all of our studies in both in uveitis, we are multi country in India, in Israel.

And as you can see an RVO we're multi-country - multi continent approach and we believe that we will have a data set that will be supported and as of right now was it relates to uveitis, we probably going to take the data first that we have for the NDA and the discussions that we found with the FDA have been positive and so we're going to submit the NDA initially with the FDA and turn our attention to the EMEA for submission in Europe where we will have further discussions with them as far as the next steps.

As far as the inclusion we had positive discussions with EMEA and feel that we have the right clinical trial and be supportive of future submissions in those territories as well. As far as the European or landscaper worldwide, I’ll let Brion Raymond maybe comment on that..

Yes. So, the European market is an attractive one both from the prevalence of disease as well as the use of steroids and they're more actively used outside the U.S. And, I think if you look at some of our competitors sales results, you'll see that ex-U.S. sales are greater than the U.S. sales, which is counter to the anti-VEGF.

And, so we believe the Europe is an attractive market for us and potentially equal to or larger than the U.S. market.

And, we've received some recent research saying that we should have some pricing power in the EU as well; encouraging I would say pricing power in the EU compared to some of the other therapies that are already approved on the market there..

And, just a couple on the DME program, do you think we can get any update on the program by the end of this year and it may be too early for this, but what are you thinking at this point in terms of potential Phase 3 trial designs in terms of patient numbers and endpoints?.

Thanks Serge. I will let Glen to comment on that at this time..

Thank you, Daniel. Serge, we'll keep you informed as we are ready to speak about this. It's likely that we should have a greater amount of input as the year goes by, but we definitely keep you and everybody else informed. I do not want to comment on trial designs.

The FDA is fairly traditional requirements for what's done for the other approvals within the framework of each of these diseases and would be doing things that would be similar to that, but of course the specifics of what we are looking at will be unique to us and we’ll of course share that once we have that ready..

Great, thanks for the update..

And, our next question comes from the line of Liana Moussatos from Wedbush. Your line is now open..

Thank you for taking my question and congratulations on your progress. Just to have a little follow-up on DME.

Have you made a date for an end of phase 2 with the FDA? And, what are your next steps before you can say anything to us what do you have to do?.

Okay. Thanks. Yes. Thanks Liana. As we ran TYBEE what we did is in order to for us to make the - to run a study without anybody specifically use CRS to do that. And, the CRA is in which we turn it with we have just now gathering lists of the individual patient. So, we're just now getting that end really as we speak today.

So, it's not like it's very - we've had an opportunity to gathering them into that. Before we’re able to submit anything to the FDA for approve - FDA meeting we'd have to create a briefing document. So, we haven't done that as well yet.

So, these are all things that we're putting together and we're going to currently we wanted to sit within our time line and this progress we continue make with this program. We will know a lot more by the next time we're talking on the phone..

Okay.

And, when in Q4 do you think the RVO data will come out? Will it be early or late or can you say?.

That's a great question. RVO has been recruiting. We've closed our SAPPHIRE data back in - back down the June time frame I believe that was when it was done. And, obviously we're going to let you pick go for two months before we can begin to gather the data. It's a large multi-location, multi-continent clinical trial.

It will take a little time to do that. So, I’m not really pointing to a direction in fourth quarter at this point. We’ll wait and see when it makes - the data comes in correctly and clean and so that's our highest priority..

Okay. Thank you very much..

Thank you for your question..

[Operator Instructions] And, our next question comes from the line of [indiscernible]. Your line is now open..

Hi guys. Thanks for taking the question. I just had a couple questions in terms of the commercial effort here.

Can you comment on your efforts for prepping in terms of reimbursement and also in terms of reps hiring, there’s a number and timing that you would have to do here?.

Yes. Brion feel free to grab that..

Sure. I think reimbursement is probably the most advanced part of our program right now. We've been working with payers cost-effectiveness models and try to understand the market and also figure out how we can - we will positioned within the payers mind.

And, all I can say is that the results that we've received back have been encouraging across the board from the model and from the payers as well.

And, on the sales front, we are targeting a sales force that's a little bit smaller than current retina sales force, but it'll be a small group and an efficient group to reach between 1,900 and 2,100 physicians will be our target market.

And, timing wise, I think we'll start planning the hiring in Q4 and based on our filing timelines and FDA feedback, we’ll start accelerating hiring in the beginning of next year..

All right, thank you, that’s helpful. And yes. No it does. And then just lastly here before SRS, you guys didn't show the sham data, the 15.6 rise in IOP.

I'm just wondering why you took the ones out that were rescued and then was the chatter mostly at SRS around the data mostly about the IOP advantages or was it - are you guys being the first ones to look at visual acuity as an endpoint?.

Yes. That's a good question. There is a little confusion but so what we did is in our sham arm of the PEACHTREE data, we have multiple ways which patients might be considered “rescue”.

The first way is that uveitis and they receive just uveitis and they want to treat it that occurred in the number, so you give them Ozurdex or intravitreal or subtenon triamcinolone, and we’ll call it local treatment and that's what we saw where 10 out of 26 patients, 28 patients, sorry, 10 out 28 patients had an intraocular pressure event from that.

So, that would have occurred probably for a week at least post from the original initiation of the trial and these patients already getting treated.

The percentage of that was, how many, 28%?.

26%..

26%, so that's where I was going for. So, that was for local treatment, but there are other reasons, while these patients may also be rescued.

So, they could have increases in some systemic problem in which they require a systemic therapy for their disease and they would be considered rescued from that or they received topical drops for some reason that they would be given for that model, I mean, exclusively anterior segment disease that could be occurring as well.

So, we just wanted to compare what the local treatment would be to a local treatment and we saw that 26% versus the 11% with the better number that we tend to show physicians.

So, the feedback we received from our physicians in our add-board was they feel like they're showing profound improvement on the efficacy both on just the best corrected visual acuity, the signs of the patient as well as the fact that there’s so few patients that were rescued at our arm versus the sham 86% of the patients made it through our clinical complete study and are now being rescued.

And, that means less patient management are very complex patient group. The lack where you have seen the side since its improvement were of interest to the [indiscernible] as well.

But also on the safety side they see this is a much greater benefit from an intraocular pressure point of view, from cataract point of view, they are really not worried about cataract too much.

But the main interest they have is that not only they are impressed by the lower rate of expecting intraocular pressure, but the lower rate of surgical events associated with this as well. And, if you have these patients who are required for further treatment and tropical drops, they feel like that's very manageable from the physician point of view..

I actually know that’s very helpful.

And then just to make sure on in terms of the sales reps hiring that when you mentioned fourth quarter was that fourth quarter ‘18 or ‘19?.

Ideally we would have a final plan by the end of fourth quarter and begin hiring the leadership team in Q1 of ‘19..

All right. Thank you very much. That's it from me..

Thank you. And, at this time we have no further questions. I’d like to turn the conference over to Daniel White for any closing remarks..

All right. Thank you once again for joining for the call today. I didn't hear you quite well operator sorry about that. We appreciate your continued interest in Clearside. We look forward updating you on our progress in the month ahead. Operator you may now disconnect..

Ladies and gentlemen, thanks for participating in today's conference. This does complete the program. You may all disconnect. Everyone have a great day..