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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q4
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Operator

Good day, ladies and gentlemen and welcome to the Q4 2018 Clearside Biomedical Inc. 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 for you to participate will follow at that time.

[Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference Ms. Jenny Kobin of Clearside Investor Relations. Ma'am, you may begin..

Jenny Kobin Head of Investor Relations

Good afternoon, everyone and thank you for joining us on the call today. Before we begin, I would like to remind you that during today's call we will be making certain forward-looking statements.

Various remarks that we make during this call about the company's future expectations plans and prospects constitute forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the Risk Factors section of our most recent Annual Report on Form 10-K for the year ended December 31, 2017 and filed with the SEC on March 16, 2018.

Clearside's quarterly report on Form 10-Q for the quarter ended September 30, 2018 and filed with the SEC on November 8, 2018 and other SEC filings all available on our website. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent day.

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. On today's call Daniel White, our President and Chief Executive Officer, will provide strategic update; Dr.

Thomas Ciulla, our Chief Medical Officer, will highlight the applicability of our platform and recently presented data; Brion Raymond, our Chief Commercial Officer, will review our plans for XIPERE; and Charlie Deignan, our CFO, will conclude the formal remarks with the financial summary. We will then open the call for your questions.

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

Daniel White

Thank you, Jenny. Good afternoon, everyone and thank you for joining us on the call today. Our focus at Clearside is to treat blinding diseases using our innovative technology platform to deliver pharmacotherapy to the back of the eye. We are pleased to announce last month that our New Drug Application, or NDA, was accepted by the FDA.

XIPERE triamcinolone acetonide ophthalmic suspension for suprachoroidal injection is now under review by the agency for the treatment of macular edema associated with uveitis. The NDA acceptance marks a significant milestone for Clearside and our unique therapeutic approach in developing treatment for people with serious eye diseases.

This novel platform combines suprachoroidal injection technology with proprietary drug formulation. Together, these components provide a targeted method for delivering pharmacotherapy to the part of the eye that requires treatment.

This method for administration is different from intravitreal injections, the current standard of delivery of drugs and then it facilitates more target delivery of therapeutic agents. Clearside will achieve many first as XIPERE is approved.

XIPERE will be the first therapy indicated for macular edema associated with uveitis, an unmet need that is leading cause of vision loss and even blindness in uveitis patients.

We will have conducted the first study that allowed patients with all four anatomic locations of uveitis and the first to use the best corrected visual acuity as a primary endpoint for the uveitic clinical trial.

And just as importantly, this is the first time the FDA is reviewing an NDA filing for a product candidate using our patented administration into the suprachoroidal space, or we may refer to this as SCS.

The FDA has provided a PDUFA goal date of October 19, 2019 for their response to our application and our team is working diligently on completing the regulatory process and launch preparations. If approved, our current plan is to formally launch XIPERE in the first quarter of 2020.

In addition to this first indication for XIPERE, we are moving our platform forward in other indications. We believe the SCS administration has broad applicability across prevalent blinding diseases such as wet AMD and diabetic macular edema, or DME. And we are further exploring small molecules and gene delivery. I will now turn the call over to Dr.

Tom Ciulla to highlight the applicability of our platform and recently presented data..

Thomas Ciulla

Thank you very much, Daniel. To complement Daniel's discussion at XIPERE I would like to reiterate some important points about trial results and why I believe physician will find this treatment beneficial in their armamentarium. I will also discuss our future clinical trial plan to potentially expand our suprachoroidal therapeutic platform.

PEACHTREE was the first Phase 3 trial to evaluate suprachoroidal injection as a technique for the treatment of any ocular disease and validates the potential of the platform for the development of other therapies. Suprachoroidal-administered XIPERE represents a novel and targeted treatment.

In PEACHTREE, XIPERE rapidly achieved high-levels of drug in the choroid and retina resulting in clinically meaningful improvement in vision in approximately half of all patients with macular edema secondary to uveitis.

Nearly 50% of patients gained three or more lines of vision, which represents a doubling of the visual angle indicating that patients were able to read letters half the size following study therapy compared to their vision at study entry.

The proportion of patients with 20/40 or better visual acuity exceeded 50% as early as week eight following XIPERE treatment, which is legal driving vision in most U.S. states. Improvement in vision was accompanied by a significant reduction of macular edema with resolution in over one-half of the XIPERE-treated patients.

Importantly, XIPERE demonstrated these results in all four anatomic locations including anterior, intermediate, posterior and pan-uveitis. In addition, the PEACHTREE responses were durable. In the MAGNOLIA extension study that we reported in January, 28 of the 96 patients who are in the XIPERE treatment arm were followed for a total of 48 weeks.

In MAGNOLIA, 50% of the XIPERE-treated patients maintained effect through 36 additional weeks after their second suprachoroidal injection without requiring additional treatment.

Recently an NIH-funded prospective clinical trial called the PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial or POINT for short compared three commonly administered local corticosteroids for uveitic macular edema.

The six-month results show that intravitreal triamcinolone and intravitreal dexamethasone outperformed periocular corticosteroid, both achieving approximately nine letters compared to approximately four letters gained in the periocular arm.

While we cannot directly compare with this trial in PEACHTREE the mean gain visual acuity was 13.8 letters at six months. Additionally in the POINT study approximately one-fourth to one-third of patients in each arm required medications to lower the intraocular pressure or IOP.

In PEACHTREE, only 7.3% of patients required the addition of IOP-lowering medications. With this data, alongside the fact that the standard size of information resolved in over two-thirds of patients in PEACHTREE, our clinical team is considering plans for potential label expansion for XIPERE.

We are also looking to expand the XIPERE label in diabetic macular edema or DME based on results from our Phase 2 TYBEE study where XIPERE administered in combination with EYLEA achieved a statistically significant mean improvement in visual acuity. This was similar to Eylea monotherapy, but with fewer treatments over the six-month time period.

In consultation with our scientific and medical advisers and evaluation of the treatment landscape, we believe XIPERE monotherapy can provide benefit to DME patients. As a result, we are currently preparing materials to discuss a path forward with the U.S.

FDA to advance the clinical development of XIPERE monotherapy into the therapeutic rotation with anti-VEGF for DME. Let me tell you about another area that I'm particularly excited about for Clearside. Beyond XIPERE, we are also investigating a suprachoroidal delivery platform with other small molecules and with gene therapy. In February, Dr.

Szilard Kiss presented our first non-clinical data providing preliminary evidence of the potential for suprachoroidal administration of gene-based therapies. In Dr. Kiss' presentation at Macular Society, he described a preclinical model in which non-viral DNA nanoparticle gene therapy was injected suprachoroidally.

This produced marker gene activity in the retina and choroid of all eyes. Interestingly, marker gene activity in those eyes underwent suprachoroidal administration was comparable to those eyes that underwent more traditional subretinal administration.

Suprachoroidal injection of non-viral DNA nanoparticle gene therapy was generally well tolerated across groups with no significant abnormalities. This preclinical work provides preliminary evidence of the potential for suprachoroidal administration of gene based therapies.

We are particularly excited about this possibility as our platform offers the potential for safer targeted ocular gene therapy without the risk of surgery and subretinal administration.

Specifically suprachoroidal administration of gene therapy does not require detachment of the photoreceptors from the retinal pigment epithelium and consequently avoids the risk of subretinal injection to an already compromised retina.

Suprachoroidal injection procedure training is minimal and could ultimately enhance patient access since it does not require specialized gene therapy treatment centers. Suprachoroidal administration may further enhance the value proposition of ocular gene therapy by potentially improving safety and expanding access.

Consequently we are now exploring both nonviral and viral gene therapy. We are excited about the potential approval of our first agent and our first indication, which is a significant milestone for a suprachoroidal drug delivery platform. For XIPERE we hope to expand our indications within uveitis, inflammation and DME.

We also believe our platform has broad applicability in other areas and continue to explore utilizing our suprachoroidal administration with other small molecules and gene therapy. I will now turn the call over to Brion Raymond, our Chief Commercial Officer to provide an update on our plans for XIPERE..

Brion Raymond

Thank you, Tom. With our NDA accepted by the FDA for review, we are one step closer to launching XIPERE for patients with macular edema associated with uveitis, a disease that currently has no approved therapies. Uveitis is a leading cause of vision impairment and blindness in the developed world and affects approximately 350,000 patients in the U.S.

annually. Of that number approximately one-third of those patients will be diagnosed with macular edema. As Daniel mentioned, macular edema is the primary cause of vision loss in uveitis patients.

It more often affects younger people resulting in the potential for numerous years of loss visual function, which adds to the importance of bringing this treatment to an underserved patient population. The positive results from our Phase 3 PEACHTREE trial demonstrated the potential benefits of our approach to treating this disease.

We believe that administrating triamcinolone via suprachoroidal injection may provide benefit over local corticosteroids given topically, intravitreally or periocularly also known as a subtenon injection.

As Tom discussed further validation for the program came earlier this year when we released data on our MAGNOLIA extension study, showing that 50% of XIPERE treated patient’s maintained effects through nine months after their second suprachoroidal injection.

Clinicians have expressed the importance of durability as they look to produce -- to reduce the burden for their patients by requiring fewer treatments and doctor's office visits. For our launch, we will be targeting the approximately 1,900 uveitis and retina specialists in the U.S.

We believe we can obtain broad traction with this concentrated set of physicians with a small focused sales force. These physicians are familiar with a variety of ocular injection approaches and routinely use steroids to treat eye diseases. So we expect they will be comfortable with the use of our platform.

Importantly it fills an unmet need for their patients with macular edema associated with uveitis. For our launch, we are focused on three key areas; physician and patient education; injection training for the physicians; and reimbursement support.

XIPERE will be an office administered therapy and will be a buy and bill therapeutic, which means the physician practices will purchase the drug and then bill insurers for their use to treat specific patients.

Therefore, we intend to complement our sales force with a small field-based reimbursement team to educate and support practices with their billing and coding efforts and interactions with our patient support hub. Additionally a small payer relations team will be working to educate payers on XIPERE and the value it provides for their customers.

We have now begun to execute on our launch plan. Given the timing of our October 19 PDUFA date; we expect to formally launch XIPERE in the first quarter of 2020 if approved.

With the positive data from our Phase 3 study, the additional efficacy data from our extension study and the encouraging feedback from key opinion leaders, we're confident we'll be able to differentiate and successfully launch XIPERE should we receive FDA approval.

Now I'd like to turn the call over to our Chief Financial Officer, Charlie Deignan to review our fourth quarter 2018 financial results..

Charlie Deignan

Thanks, Brion. In the fourth quarter of 2018, Clearside's research and development expenses were $17.5 million, compared to $13.9 million in the year-ago quarter.

The $3.6 million increase was primarily related to Clearside's clinical development programs including one-time costs related to closing down the two Phase 3 retinal vein occlusion clinical studies last year. General and administrative expenses for the fourth quarter of 2018 were $4.2 million compared to $2.4 million in the year-ago quarter.

The $1.8 million increase was mostly attributable to employee-related costs and marketing-related expenses as we prepare for the potential commercialization of XIPERE. The net loss for the fourth quarter of 2018 was $21.6 million or $0.68 per share, compared to $15.5 million or $0.65 per share in the year-ago quarter.

The increase in the net loss was primarily related to higher research and development expense. As of December 31, 2018 our cash, cash equivalents and short-term investments totaled $40.9 million.

Since then we have augmented our year-end 2018 cash balance with approximately $5.6 million of net proceeds from sales of common stock under our aftermarket facility. As we look forward, we have reduced R&D expenses by shutting down the RVO clinical trials and are allocating funds to our near-term priorities including the launch of XIPERE.

Based on our current plans for commercializing XIPERE, our ongoing research and development activities and our anticipated available funding facilities we expect to have sufficient resources to fund our planned operations into the first quarter of 2020.

This includes the potential launch of XIPERE for the treatment of macular edema associated with uveitis. And with that, I'll turn the call back over to Daniel for his closing remarks.

Daniel?.

Daniel White

Thank you Charlie. This is an exciting time for Clearside, as we deliver on the promise of the innovative therapeutic approach that our founding scientists discovered. We hold the exclusive rights to develop and commercialize pharmacologic agents for treatment of eye diseases via suprachoroidal injection.

We believe the product candidates we developed through our therapeutic platform has the potential to become the standard of care for the treatment of retinal and choroidal diseases. We intend to leverage this platform to make a difference for patients in the U.S. and around the world.

Our action plan is to complete the regulatory process, prepare for a successful launch, expand our expertise in uveitis to broader indications, prudently build our ophthalmic pipeline and work with potential partners to leverage our platform and provide global reach.

We appreciate the support of our many stakeholders, including patients, investigators, shareholders, analysts and employees who have a commitment to understanding and advancing the valuable treatment Clearside can provide. I'd now like to ask the operator to open the call up for questions.

Operator?.

Operator

Thank you. [Operator Instructions] Our first question comes from Anupam Rama with JPMorgan. Your line is now open..

Tessa Romero

This is Tessa on for Anupam today. Thank you for the updates here and also taking our questions.

Can you maybe comment on how the post-hoc analysis are going in RVO and for DME? As I recall you guys were working towards publishing peer-reviewed articles on both clinical experiences that might shed light on what to do next with XIPERE? And then relatedly if I could, when do you think we might have an update on potential monotherapy indications that may be valuable to pursue here? And any other color you can provide acknowledging that it sounds like the FDA discussions are ongoing?.

Daniel White

Thanks Tessa, appreciate your question. We knew there'd be a question about retinal vein occlusion. I'll ask Tom Ciulla to answer that one first and also cover the other questions that you have as well..

Thomas Ciulla

Yes. So for -- as you know for SAPPHIRE, we found that combination therapy performs well with around 50% of patients achieving three lines of vision at the primary endpoint.

However, the trial is discontinued because of the strict monthly regimen that the anti-VEGF therapy performed very well and we're unable to tease out any additional benefit of the combination therefore we discontinued the studies.

Further analysis has essentially confirmed our initial analysis that combination therapy did not provide any additional benefit because the monotherapy Eylea arm performed so well. And then you asked about expansion of monotherapy for XIPERE.

We are currently considering our TYBEE Phase II trial and we want to discuss some questions with the FDA as we prepare meetings -- as we prepare materials to schedule a meeting. The timing of the meeting isn't set, but we hope to meet with them in the second half of the year.

We do feel that there's a role for XIPERE as monotherapy in DME and other potential indications outside of uveitis, so much of the approval and use of other steroid products for these indications..

A – Daniel White

And Tessa there was one additional question. I don't know if we answered that..

Q – Tessa Romero

That was -- no perfect. Thank you. Thank you very much guys. It’s super helpful and congrats on the progress..

A – Daniel White

Thank you, Tessa..

Operator

Thank you. And our next question comes from Annabel Samimy with Stifel. Your line is now open..

Q – Nick Rubino

Good afternoon everyone. This is Nick Rubino on for Annabel. Thanks for taking our questions.

I guess, we're just wondering what efforts are necessary to educate physicians on the treatment of XIPERE? Have you been able to start the training specifics in preparation of the launch? And then do you have any thoughts on uveitis' competitive landscape and whether the launch of new steroid implants could leave an already small market more fragmented for you? Thanks..

A – Daniel White

Thank you, Nick. I appreciate the question. Brion that's up your alley..

A – Brion Raymond

First on the injection training needs. So the suprachoroidal injection is similar to an intravitreal injection in all the prep and things like that, but there's actually a technique that needs to be taught to all physicians prior to their first injection.

And we'll be developing a multi-faceted injection training program that includes our sales reps; it includes peer-to-peer training as well as online training to ensure we can rapidly train the small, but advanced physician base that we're going after.

This is -- learning new technique is nothing new to them and they've been great in helping us kind of design what we need to provide. And from a competitive standpoint, the three-year implants are being positioned us by the companies and according to our advisers as really for those patients that require chronic therapy.

Whereas XIPERE is really when the patient walks in if they have edema, they'll treat first the XIPERE and then see if they can cure the uveitis. And if those patients persist on past a year, I believe that's the role that Yutiq will play and Retisert as well over the long run..

Q – Nick Rubino

All right, great, sounds good. Thank you very much..

Operator

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

Q – Liana Moussatos

Thank you for taking my questions.

In addition to the medical education, can you update us on other launch preparations this year? Also how many sales reps are you going to hire? And when will you start hiring them?.

A – Brion Raymond

Sure. So as I mentioned, our top priorities are physician and patient education on both the injection procedure and the data once we receive approval. Second is injection training and third is really reimbursement support.

With this being a buy-and-bill product, the first initiating the incorporation of this drug into a practice and assisting all the way through reimbursement to the extent that we're able to are really our top three priorities. From a staffing perspective, we've said all along that we'd be able to reach this market with a small sales force.

Definitely under 30 reps at this point is what we're looking at. But we're still working through the territory alignments and deciding exactly how large of a sales force or how concentrated of a sales force we can have in order to be successful and reach all of our customers.

In addition to them, we'll also have a very small payer team and a field reimbursement team supporting both payers and practices.

Was there another question Liana that I didn't get to?.

Q – Liana Moussatos

When will you start hiring sales reps?.

A – Brion Raymond

We've decided to make ourselves offers contingent upon approval. So we'll begin bringing a leadership team onboard soon, but the actual sales reps and the other field reps their offers will be contingent upon approval..

Q – Liana Moussatos

Thank you..

Operator

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

Q – Tian Sun

Hey, this is Tian on for Serge. Most of my questions have been answered. But for that MAGNOLIA extension data through 48 weeks where it showed 50% of patients did not need to receive any medications.

Is this something you plan to maybe supplement into your marketing material? And do you have any I guess additional color on the other half of the patients the 50% who did need additional medications? Was there something different about that population? Thank you..

Daniel White

Why don't we answer that question in reverse? Let's talk about the patients, who did not receive or didn't require retreatment.

Tom, do you have any color to that?.

Thomas Ciulla

Sure. So as you may know MAGNOLIA was a prospective non-interventional masked observation 24 week extension of PEACHTREE. So basically patients who were not rescued in PEACHTREE were eligible for MAGNOLIA and in that study as patients were rescued, they basically exited the study.

And we did this in order to get more information with regard to the durability. And what we found at the end of the 24 week extension which was 48 weeks from the beginning of PEACHTREE approximately half the patients did not need rescue after their second PEACHTREE protocol-mandated dose. So I don't know if that answers your question..

Daniel White

Yes.

And the other half?.

Thomas Ciulla

So the other half as they were rescued they exited MAGNOLIA..

Q – Tian Sun

Got you. That makes more sense now. Thanks..

Daniel White

And so by definition just to add color to that they would have had to gone at least three months to be at the end of PEACHTREE to qualify for it..

Q – Tian Sun

Got you..

Brion Raymond

And unfortunately, I don't have a great answer. But using MAGNOLIA from a marketing perspective, we will be discussing the data with the FDA. However, those deliberations are currently ongoing and will continue to go on until our PDUFA date. So I really can't answer whether we'll be able to use that or not from a marketing perspective..

Q – Tian Sun

Got you. Those very helpful. Thanks..

Daniel White

You’re welcome..

Operator

Thank you. Our next question comes from François Brisebois with Laidlaw. Your line is now open..

François Brisebois

Hey, guys. Thanks for taking the questions. Most have been answered, but I'm just wondering when you talked about the – that was interesting answer on the three-year competition kind of implants.

I was wondering, in terms of competition for maybe the short acting cheaper generic steroids, how do you think the medical community will kind of attack that?.

Daniel White

Frank, that's a great question. We try to illustrate that a little bit in our presentation remarks around the POINT Study. So as you know, the illustrative theme that macular edema associated with uveitis is a critical disease state that – where patients can result in blindness, if not adequately treated.

These patients who come in, they typically are – did receive a drop automatically and then they're going to be tested to see whether or not they're infectious or not infectious. And then they'll go into some regimen.

Of those generic treatments, Tom, why don't you talk about that since you've seen many of these patients?.

Thomas Ciulla

Sure. So, it's a great question. As Daniel alluded to in the POINT Study, there were three commonly used local corticosteroids for the treatment of uveitic macular edema. Two of those were generic corticosteroids triamcinolone. One was interocular and one was periocular.

And what's important to point out although we can't directly compare this to PEACHTREE, it is interesting to note that patients with the interocular injection improved by about nine letters compared to patients with the periocular which is about four letters. And in PEACHTREE, we had a 13.8 letter gain at six months.

Additionally, or even more importantly, in the POINT Study approximately one-quarter to one-third of the patients in these arms required medication to lower their IOP, and again, we can't directly compare it, but it is intriguing to note that in PEACHTREE only 7.3% of patients required the addition of IOP lowering medications. So I think –.

Brion Raymond

Yeah. And from a competitive standpoint, and I sort of mentioned this when I was answering Liana's question YUTIQ and OZURDEX are approved and indicated and only paid for, for posterior uveitis or uveitis involving the posterior segment. Whereas our trial included all anatomic locations including anterior uveitis patients with macular edema.

From a safety perspective, I would also like to remind everyone that our rates that Tom just quoted are after two injections of triamcinolone and the data that you see out there is after one injection of our competitive products. So, I think we stack up nicely competitively when we get in the market..

Daniel White

And I think additionally we allowed patients to come end of the trial where that was an exclusion criteria for many of the long-acting corticosteroids in their clinical programs. So, we like to believe that we are making a meaningful impact on the risk-benefit profile between any of these products..

François Brisebois

That's great. Now, that's very helpful in-depth answer. So -- and then to switch to gene therapy, I think that angle is really interesting.

Can you talk about kind of the relationship between the transition from preclinical data to clinical data in this kind of indication or in gene therapy how that could relate usually?.

Daniel White

Yes. So, this is Daniel. I want to commend our teams for looking at -- particularly in the discovery area of Clearside who are not associated with the XIPERE launch or its further development. And this team has been working very closely to identify the key target.

As we closed out last year and even some data from this year we found that in both non-human primate as well as other animal species in both viral and non-viral approaches that means AAV and approaches without viral capsid we were able to demonstrate expression equivalent to that of a sub-retinal injection. Now, that's using marker genes, of course.

So, we take the marker gene information and now we've taken this team of terrific talent who's joined our company recently and we've identified several therapeutic targets that are fascinating. We're going to talk about them on a later date, but we believe that we have some very unique capabilities for delivering through this approach.

Tom would you like to add more color to that?.

Thomas Ciulla

Sure. So, as you know the only approved gene therapy for retinal disease as well as many of the investigational gene therapies require sub-retinal surgery.

And in that sub-retinal surgery a part of this plan of attracting this is to perform a small retinotomy or a hole in the retina is created and essentially the retina is detached temporarily so that the gene therapy can be exposed to both the photoreceptor rods and cones in the retinal pigment epithelium. That obviously entails significant risk.

In addition you're creating a retinal detachment in an already compromised retina.

And so if we cannot -- or minimally invasively administer gene therapy for example with our suprachoroidal approach we can circumvent that risk of surgery the risk of sub-retinal injection and also enhance patient access potentially have this become an office-based procedure.

So, you asked about the translation from preclinical to clinical, I actually think there's almost a simpler translation where we can have gene therapies that are already investigational and some of those therapies may wish to perform trials to see if a suprachoroidal injection would yield benefit without the risk of surgery.

So, I think it's a very simple translation because the route of administration, if it's effective, clearly has safety advantages and patient access advantages..

Daniel White

I think it's also worth mentioning that we're taking a very prudent approach at doing this. We understand where we stand and as a company, trying to launch a product as well as develop and R&D.

We've been collaborating with many terrific universities as well as major companies to help develop this concept from our own -- from their point of view as well and perhaps provide immediate opportunity to build this gene therapy expertise within the company as we continue to go down that path..

Thomas Ciulla

I'd like to add just one more point. With suprachoroidal injection, there is a potential to change the entire paradigm in gene therapy. Specifically, right now, gene therapy is maybe difficult to repeat because you have a virus capsid which creates an immune response.

In addition, performing sub-retinal surgery also is really difficult to repeat for safety reasons. So, with suprachoroidal injection, we have the potential to repeat administer gene therapy and we're interested in the non-viral approach because that doesn't induce inflammation and that can be repeated.

So, we -- there's a potential for a repeatable gene therapy that is a nonviral approach to be repeatedly injected with the suprachoroidal approach because it's minimally invasive. And so, we can marry these two technologies to achieve some significant synergies..

Francois Brisebois

Okay. Great. That’s very helpful. Thank you. That’s it for me..

Daniel White

Thank you, Frank..

Operator

Thank you. And we have a follow-up from Liana Moussatos with Wedbush Securities. Your line is now open..

Liana Moussatos

You've been talking a lot about gene therapy.

Will gene therapy or small molecule be the next program for Clearside for SCS injection?.

Daniel White

Liana, thank you. That's a great question. As we look forward into the future about where our company is going, again, I want to commend my team for developing some very granular, very approachable targets. Some of which are gene therapy. Some of which are small molecules. And our collaborations continue to advance in both of those areas.

I think there's -- what we have to do is prioritize these targets for us to pick the appropriate candidate that give us the best chance of success. While XIPERE is being not only launched, as well as we can consider what are some of the other indications that that could be applied for.

And just as a reminder XIPERE is -- triamcinolone is a small molecule and it was our model molecule for showing that the suprachoroidal space is an outstanding area to go and to treat these retinal diseases..

Liana Moussatos

Do you anticipate a new program in 2019, or is that more 2020?.

Daniel White

I can't really have an answer for that. First, we have to define what program means and I would like to get into that with you in a future date. Thank you so much..

Liana Moussatos

Thank you..

Operator

Thank you. And I'm showing no further questions in the queue at this time. I'd like to turn the call back over to Daniel White, President and CEO, for any closing remarks..

Daniel White

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. Operator, you may now disconnect..

Operator

Thank you. Ladies and gentlemen, thank you for your participation. You may all disconnect. Everyone have a great day..

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