CLSD - Earnings call transcript Q4 2017 | Clearside Biomedical, Inc.

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Operator

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.

Stephen Kilmer

you. Thank and joining everyone, you thank morning, us. for Good

during a risk at these like can you various SEC the the be to of those may important future by accessed be that and Form annual we we certain begin, for today’s in expectations, Act remind result XXXX factors, of Edgar of would with which I make we filings other for that constitute including as remarks materially will differ factors report on statements the indicated Before plans on during and the the discussed forward-looking Reform or to call, time. results those make the year statements. XX-K www.sec.gov from Private our XX, to Various with filed XXXX. the call ended forward-looking Litigation about prospects, Actual December section this database time about SEC forward-looking March statements of company’s be XXXX, making purposes on from we XX, Securities

statements any as as represent representing any views views of today only forward-looking and relied should our addition, In of date. subsequent upon as not be our

any point, disclaim relied upon these as update statements we elect subsequent statements be not our forward-looking today. date may of should to even While to views representing any do if views at we some so, forward-looking to future specifically obligation change. as These our

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

Daniel White

us morning, you Thank everyone on and joining thank you, call today. Steve. the for all Good

for I’ll our then will clinical discussion end of will and side, have time financial Before through call. finally we the I catching layout programs, taking we with up for call our Charlie Clearside discuss will the be development at me details will our today’s be main Glen Q&A. you the summarize the agenda you of let briefly begin, the results, and

are Clearside For Biomedical transformative highlight mission. developing preserve like new solutions elegant to the and to to those to our precise of a take I’d is company’s moment vision. restore benefit story, who Clearside designed

we three solutions access for our As development Retinal centimeters our drug suprachoroidal the of a of challenges administration, diseases uveitis, diseases Clearside in a sight a advanced of unique the with that retina I where is Vein as and drug triamcinolone square is and company, to we acetonide begin the complication. common of finding on suspension Suprachoroidal CLS-TA and programs. distribution Occlusion Diabetic Edema RVO, currently proprietary the to corticosteroid provides stand with candidate each In a treating choroid. update candidate. brief formulation or of on the clinical or XX take space. product them, Edema like most a of better is such for Macular where unique proprietary eye hold for called Macular a we injection DME threatening suprachoroidal

build-up drug XXXX blindness. suprachoroidal a is most and of uveitis. non-infectious effecting of approximately patients. Suprachoroidal the set occurs the week, uveitis start the an entrance of using of attractive global our effecting vision. associated and contributor States, of represents treatment to causes in CLS-TA $X conditions the a macular all edema endpoints to sharp billion CLS-TA a in responsible edema opportunity. the for advanced macular, of over achieved proprietary expected patients. candidate blindness eye straight-ahead primary by the from the and macular early non-infectious edema non-infectious in remains world’s which improvement Phase Suprachoroidal Macular uveitis X trial pivotal edema first edema macular pivotal the uveitis. then announced primary a is associated key for to and using and macular The with these fluid program the with center Let’s of of In CLS-TA of area in line our edema. treatment Uveitis vision in Macular macular cause developed leading one X loss with we in inflammatory non-infectious in the visual patients the being with The of places to one the the positive approximately PEACHTREE secondary FDA clinical by if validating endpoint last is major at distorts Phase reach CLS-TA approach causes and market uveitis in successfully leading potential top XXX,XXX Suprachoroidal approved is with with our non-infectious thicken trial United become retina build-up Fluid one-third very of for vision. associated uveitis, were market results first swell trial acuity a the in

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

of to for patients suprachoroidal CLS-TA XXXX. application new submit with a in edema to non-infectious FDA the with macular in expect We fourth the uveitis associated drug quarter

outside regulatory for U.S. in to also options the a agencies We are evaluating additional territories potential number submissions of

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

would newly show alone earlier intravitreal that in is anti-VEGF of together intravitreal can outcomes used diagnosed we we to visual agent longer better CLS-TA vision a if we to as that with result suprachoroidal injections visual an acuity compared monthly RVO opportunity to preserve early and to superior anti-VEGF objective in over Our achieve disease an the the have patients. stages in of a outcomes term. see better Ideally, like

roll To clinical continuing with of at XXXX. two provide of with announced X in enrollment on Eylea. week, more looking report clinical we preliminary treatment used Suprachoroidal design Phase from trial first can similar Based is in first the to of our fourth X the suprachoroidal The SAPPHIRE aggressive anti-VEGF strong our durable we anti-VEGF TOPAZ effective, the is enrollment vision patients the approved the called therapies. currently RVO. agent develop initiated that agent and an to that also vision we most which to a than of data expect CLS-TA in one is patient first called that SAPPHIRE, second TOPAZ approaches in of quarter Phase and SAPPHIRE. permanent to vascular rapid, trials today, retinal RVO Last impairment RVO Phase patients to of are there SAPPHIRE end, potential combinations and of As in CLS-TA we progressing XXXX. used quarter trial intravitreal diseases is loss need with lead new

one [Operator with of X and TOPAZ intravitreal SAPPHIRE, CLS-TA Difficulty] we first different second looking used patients there is In where The one an is trial Our [Technical trial, TOPAZ second we However and to with anti-VEGF talking announced similar the difference. were key with trial, the called anti-VEGF of TOPAZ used phase Avastin. about where RVO. last Phase Instructions] suprachoroidal discussion, of of Lucentis suprachoroidal our however together enrollment two intravitreal agents, design are week at CLS-TA in agent

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

with to DME for of to approximately more, or people Our CLS-TA these most our to for DME. visual visual and diabetes RVO common if work untreated, include another who effects mellitus. called also condition the Edema XX% XX% loss had of XX years disease for is us of in-part in work development will cause expand diabetes Diabetic It in laid up XX% people patients to programs ground retinal experience vascular or loss. have the Macular

treatment. Phase repeated standard diagnosed intravitreal has improve believe injections treatment to anti-VEGF XX% of patients, exploratory both DME been have the While with used an large the as XXXX, newly monthly multicentered the together months HULK in for six treating including label need agent this are diabetes agents the even corticosteroids X DME. anti-VEGF CLS-TA potential treatment without in open anti-VEGF DME still through with suprachoroidal the we and the of of treatment have CLS-TA both outcomes substantial and believe be suprachoroidal for patients the pathways, patients intravitreal multiple response associated In of We to study of effective of We inhibitors current an unmet Study for X, to by the with second of intravitreal population. insufficient anti-VEGF quarter an DME. treatment of to caused in burden is Eylea reduce approximately of that shown with called patient of and completion enrolment announced with DME thought complication there eye is that use agents, care

As of enrolment X the Phase trial of together treatment enrollment in TYBEE with used represents who our past were TYBEE a findings Glen clinical Eylea AAO an At milestone which patient were CLS-TA DME DME. step development toward study, will this to trial, The in from randomized, clinical announced completed their important November discuss, a at of we controlled the QX, patient masked, and also for completion preliminary program. patients encouraging. trial naive are

we potential it our of Recently, suprachoroidal represent any agent. I’ll XXX in to RVO Glen? is topline TYBEE disease. to the Clearside adverse our turn the and model development treat and the programs now second later as received release over programs SCS allowance treatment this awareness its of RVO use our allowance all to to in eye together the our in and the important our uveitis to important XXth to well market outcomes Glen ensure injection results than of of undergone clinical date to be note supportive is preliminary expect the anti-VEGF and an And XXX continue given DME. also trial of very potential on as details program in also from suprachoroidal protecting agent the specifically diseases the the DME continue suprachoroidal opportunities PEACHTREE This CLS-TA We our particular more United relates that CLS-TA on procedure. approach related quarter are to XXXX. clinical CFO, serious treatment inflammatory trials, to in from investigators for patent have with to events, in from suprachoroidal It stage provide patients our proprietary protective. call that States data ocular including advance and to without over injections more

Glen Noronha

Thank you, Daniel.

of to a PEACHTREE top-line trial call As know conference you the separate we last discuss week held most results.

sites from of in course details will by all procedures injections patients I a by retinopathy efficacy the received of lines XX-weeks was PEACHTREE of across measure of of corrected rather summary were scale two study discussion. with sham least treatment U.S., in information, or patients two apart. in provide analyzing CLS-TA change proportion and the research baseline XX-weeks. and the XX So enrolled our The the repeating visual a the adverse key uveitis suprachoroidal to than at the of focus the at primary diabetic was three early acuity safety changes randomized occurrence parameters India, as XX XXX Patients outcome measured the Israel. best to assessed trial. events, letters Safety over of

also evaluated. and endpoints were safety efficacy Additional

ETDRS visual its letters was measured As corrected XX XX% who This PEACHTREE, received statistically Daniel week compared met less of every weeks. mentioned, suprachoroidal with endpoint. P than weeks, improvement a value X.XXX. XX CLS-TA the patients sham baseline procedures XX% of In as at significant XX XX, patients to from at gained underwent in acuity best primary least every trial

control four, was statistically arm. letters early improvements of mean X.X letters at on gained four, BCVA, maintained the was on BCVA in was terms as letters four evaluation that on than at significant. week in mean CLS-TA better the XX and than monthly arm as X.X mean in improvement gained at evaluation. was gained week In the in XX.X through baseline the each treatment with change letters These sham period to week The in BCVA the improvements at week changes the in gained week X.X and compared sham XX in seen

also pressure through the to suprachoroidal less of baseline administration the adverse was a CLS-TA events value endpoints, elevated in subfield at XX with statistically reduction trial week the treatments of in compared trial. Suprachoroidal CLS-TA mean central X.XXX. XXX CLS-TA a thickness The XX XX-weeks micron in treatment microns reported no well patients completed result from to the generally in arm, secondary sham for key events group. group, with control other was in compared to the tolerated XX% no patients approximately of serious arm. reduction resulted CLS-TA in than related mean related in significant of that were For steroid intraocular XX.X% the adverse the patients reported P

subgroup continuing understand to under six are effect. evaluate a of the for of protocol to separate We the months the a subject, additional an trial durability

Let us attention turn our program. RVO our to

when have acuity, reduce agents of with treatment As with CLS-TA Dan intravitreal. intravitreal of evidence RVO suprachoroidal alone. frequency intravitreal used has use are medical agents macular we and combination a improved each patients to as as RVO, an monotherapy uveitis. in addition agent that reduced exploring administration advantages anti-VEGF and anti-VEGF The provides detailed, along edema, as visual to and anti-VEGF suprachoroidal corticosteroids our treating CLS-TA literature compared with in known In provide

a Eylea initial The than XX intravitreal multi-center, the conducted Phase eight randomized the max, receive patients SAPPHIRE not alone. is more on RVO investigational XXX approximately with a in either intravitreal to control of proportion at country the is BCVA of double XX CLS-TA with to with patients suprachoroidal in letters of treatment. be treatment approximately together countries. year-long arm to determine Patients on patients which multi in of controlled trial objective SAPPHIRE trials randomized they at potential Eylea each first the improvement baseline X to being combination equal across will sites an weeks receive after with will clinical or which arm primary called Our in

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

and CLS-TA XX-letter only eight the Eylea the XX% the seen compared improvements patients of While three P an Eylea in of visual aggregate in improvement month one statistically fewer observation Eylea was the maintained XX% suprachoroidal acuity at were with This improvements from of trial. significant trial, had at treatments through to intravitreal a injection visual Edema Macular Eylea monotherapy additional value months with of an a result X.XXX. and at intravitreal with Further, in received TANZANITE acuity period of baseline showed weeks. seen combination

at results Phase the of the with on the beginning together additional Avastin treatment. the in and CLS-TA will now visual more initial improvement total We determine TOPAZ. treatment together also enrolling efficacy agent the arm evaluated. of approximately of each agents an week trial. of trial baseline best mention at patients and patients last without in trial four CLS-TA efficacy attention bevacizumab the of press will intravitreal eight anti-VEGF our months. alone will XXXX. to diabetic that trial trial anticipate the Lucentis will treat, suprachoroidal be evaluated XX. of the secondary with intravitreal the Eylea objective to for in program, patients After anti-VEGF Several X in the the third program. completed agent anti-VEGF are the mass-controlled be release and with endpoints to and the The letter primary are XX also be will we an through second CLS-TA safety at In our X was acuity, and trial, Patients our now anti-VEGF six arm we one The vascular beginning is patients Phase second we with in and and Daniel or enrolment suprachoroidal the we in intravitreal quarter Vein followed corrected an patients As along in weeks after every at a and the with DME. this clinical used in agent arm major or together combination receive last trial proportion our seeking patients in design April patient suprachoroidal retinal SAPPHIRE intravitreal Retinal Patients trial DME XX similar XX receive I Occlusion trial; with in reported suprachoroidal to each Phase want where XXX intravitreal trial. we XX. enrolment our four randomized announced Topaz approximately and week week, an or trial X, trial naïve second to in control of of safety or CLS-TA have a condition the of intravitreal weeks, completed the from weeks anti-VEGF X edema turn year HULK agents have weeks X other clinical In to first of Phase fourth of is which DME preliminary two were Phase X ranibizumab macular and multi-center with

Subspecialty or treated which including preliminary tolerated Eylea treatment. trial six-month five improvement eyes excess patients through a was presented require treatment Dr. of with period of as initial randomly with In data along Phase central X HULK, suprachoroidal than the evaluation greater by XX% one eye side Charlie requiring than of the thickness of of group, two-thirds with the While was terms period. in XX% they in achieving visual evaluated towards Wykoff needed fixed showed of incidence six-month have not months in generally first the patients anatomical did safety also intravitreal six-month suggest in Further, DME months Eylea efficacy ocular six this many best in with assigned the signals was a XX% we study, and injections on well CLS-TA who compared the additional improvements retreatment. well over tolerated. combination trend in CLS-TA along Initial the only results low received November, that Retina primary the acuity as period. Eylea. CLS-TA, evaluation particularly an Suprachoroidal treatment a during will durability with entire over visual in as effect, intraocular in safety and patients encouraging American for were from retinal for October Day intravitreal macular portion outcome on. to in suprachoroidal reduction only with all naïve including treatment edema The X:X and following changes patient controlled Ophthalmology retreatment In of a with was anatomical evaluate of intravitreal followed a this adverse evaluation those in Academy CLS-TA a corrected more In In portion. with XXXX, three with intravitreal drove patients events X the named Phase an trial we a combination DME associated through multi-center the monotherapy with trial pressure. announced TYBEE elevated mass-controlled enrolment randomized completion Eylea observed

the While announce monotherapy acuity change trial safety and and will measure the best the of this from on Patients arm. be efficacy quarter compared that the XXXX. to six primary in in we is evaluated be data baseline, follow-up months preliminary expect would second the from the combination to corrected be in where trial, outcome treatment TYBEE from visual will data in

Financial to over Charlie? had our teams appreciate developmental XXXX results. Deignan and I’ll busy quarter review the turn Chief financial Charlie Officer, call all efforts. productive of XXXX and to their now full-year fourth a and our Our we

Charlie Deignan

Thanks Glen.

XXXX. fourth for development reported $XX quarter our the this period same million to for compared we million expenses and research morning, in the As $X XXXX, were

XXXX third advancing our development remarks and from the XXXX Phase both of in Daniel week, or and respectively. for and of million, data $X.X which or call, $X.XX the in mentioned quarter compared uveitis with we RVO X with Phase October April loss and was topline were XXXX opening fourth in we X, for the and development the Cash $XX increase which fourth per unchanged completed trials expected. million associated an XXXX. gross net totaled quarter expenses cash from activities approximately non-infectious used million. last The $XX.X continuing our in share, highlighted edema RVO, for same $XX.X General macular per XXXX operating of period DME, fourth reporting At our X proceeds Glen trials week. trial quarter million. And clinical on patients same been million. public XXXX. programs as share with XXXX The to our quarter As for quarter equivalents their XX, X our in administrative was have in and $XX we enrolment million the raised for $X.X in associated offering of Phase in Phase $X.XX cash, X investments DME completion and Earlier December uveitis, a today, of in R&D we XXXX short-term our costs programs had was this with we

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

cash of Our goal years to back And is expect I’ll end the that, data for the Daniel call closing remarks. year with our to his X before RVO of that. have and after the approximately Phase to Daniel? over report this turn remaining we

Daniel White

for Clearside's want thank you, Charlie. Thank to to shareholders their strategy. continued support our I personally

This and and conduct been treatments. X potential uveitis. Phase other than may our planning nonclinical very to fund authorizations endpoints, observations distribution for of models if in wider we pleased demonstrate to made have recent eye the complex, drug clinical drug now that suprachoroidal potential lead Clearside's commercialization well a the greater topline RVO accessibility by trials in should provided pivotal unique DME The suprachoroidal diseases I’m due our are meet conducting As our sight-threatening future, the company's operations, of are Charlie candidate. using data obtained. have In their reflected mentioned, continues treating Phases public powerful to product primary CLS-TA the delivery. market offering the utility strategy or

opportunity just ahead help pipeline with were a commercial of of designed to that diseases, responsible transition the support This was and management and I a built will of XXXX, United caliber data Clearside in infrastructure and relationships take In He Officer. we the answer want is here at able development Clearside's States. your strategy this key the that if We to by have the Chief diseases important and retinal before establishment concludes driven development Chairman strong of I’m questions tremendous commercialized concluding, FDA the drug, his to position treatments build Humphrey, today remarks team brings ophthalmic appointed a on that focused ophthalmic and to into continue a our the Clearside. changes the at to hired of this created regard, Brion newly the Lucentis, prepared choroidal excited a management if couple Genentech Clearside’s for to approved Also, comprehensive our of to member will to commercial and board. highlight day. obtain for of FDA. was indication. a relevant amount us support since who sight-threatening attract of Clearside we targeting Commercial execution of company executive a were specialist first PEACHTREE Brion announced of experience team for approval and Bill our in director to of time. Raymond drug. retinal be launching to was accomplish Brion help blockbuster

and far so quarter. like the I’d the for to significant first the into open last call questions, year, progress to entire team the my thanks Clearside to made we’ve Before express throughout I

are mission. with and our We professionals that, commitment we we have goals, delivered capable With team key [Operator open questions. of appreciate first that from question comes on a call Operator? consistently now will to Thank JPMorgan. the Rama for Anupam highly our you. strong Instructions] Our their

is line open. Your

Unidentified Analyst

Anupam the for and this coming guess powered you in that questions and our arm? endpoints for in XQ, on congratulations guys. looking Phase be is This have we data year-end and soon TYBEE the visual the here line monitor the trial on control assumed is show of for in what Thanks taking will gain there Thank towards visual is up I wait what in DME acuity will secondary acuity the later year? other this key here. us, top part X guys. set update to Hi wondering the and any read-out What [indiscernible] for is morning. to to from out and

Daniel White

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

Glen Noronha

Thank you, And the thank for Daniel. you questions.

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

terms of they in but normally studies those are the between available in various at gaining look at? you those Eylea. mean letters, who look change we with These look are including XX see gained We see usually the and in patients subfield outcomes. the With letters, all at XX information, meaningful that XX changes clinical Now, at improvement, the will percentage look terms X at of Eylea you XX at at pieces of gain it’s those central on months, gained from information thickness. thickness, retinal look levels that are data proportion we that prescribing to who six what all are study, of of you regard nothing, key five data and excess will letters letters in these depending to, the in what other letters, the

And We we at will key XX get clinical as parameters course where time the possible that within that trials study and framework then to medical are over look usually in injections we could in and the the that out our of in an as normal of of several key include weeks all up. the the at additional can arm the come all also in we the an each preliminary the at well that for Eylea as number initially the that and items best look to onwards, abstract safety look course present look next shortest data will is get we upcoming at the all throughout given data at presentation us complete the of week conference technology. It dataset. we

Unidentified Analyst

Okay great. Thanks our for questions. taking

Operator

Thank you.

Stifel. with Samimy Annabel from comes question next Our

mispronounced I that. if Sorry,

is open. line Your

Annabel Samimy

Hello, my hi guys. Thanks questions. taking for

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

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

Daniel White

Annabel, thank good to and you, Thanks you. for question. your talking

to touch and to it this, on going to I’m one Glen. over just So, hand part of I'm going

diseases, maybe want the PEACHTREE side other were when results is in other uveitis retinal going as on Occlusion different on as question, how multifactorial. have as well slightly be DME, you macular I Retinal effective very in might would of than look we the different with uveitis, or data steroids expect - diabetic as of All the of but comment it does complex it with… to may multifactorial, edema. And these from and be multifactorial, so we Vein we this diseases saw are as well encouraged than out think the to Glen, if

Glen Noronha

Certainly.

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

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

Annabel Samimy

Great. Okay. Thank you.

Operator

you. Thank

with from question next Moussatos Wedbush. Our Liana comes

Your line is open.

Liana Moussatos

steps NDA an progress Again, to and on for QX submitting data. NIU? congratulations in the What are your great

Daniel White

Thanks Liana.

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

to need [ph]. clinical clinical work cloud pivotal to the do the overall will So support we that’s all

continuing of patients are look to these We some durability the at to treatment. of follow

course other point And Glen think this. the of made this make can how of his side then is I picture in we that comments.

microinjector year. add to this color more want actively We as well this, engaged as the manufacturing been some to any you drug, the of NDA for both to file trying and end by of have you if have purpose Glen, thoughts? the of in the may this

Glen Noronha

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

Liana Moussatos

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

Daniel White

for question. you, Thank that Liana

the have we manage of into sales. manage up peak designed - way this all So, to all our to

locations. capacity first early start have are and actually of support have both different will the will plenty of drug, we there. years on, ahead to whether as we we see the demand, in is launch the of microinjector the terms in as few a plenty going product But We’re and manufactured of at there well which

Liana Moussatos

for questions. taking much very my you, Thank

Daniel White

you. thank Great,

Operator

Thank you.

comes Serge next question Our with from Needham. Belanger

is Your line open. now

Serge Belanger

good morning. Hi

regulatory potential some near the partnership whether just expect I and what regulatory agencies filings? future kind Firstly, these regulatory you’ve with we in go U.S. with the of program, should these and question filings we on have you of a the then conversations uveitis discussed to had described, forward kind outside guess

Daniel White

Thanks Serge. the for Thanks, question.

thorough the We are we what a conversations approval. the receiving about topline States required the and a product now with FDA just United is data here tried in for

a that with as or there this are topline United either start part you outside our upon. for We in throughout both well-known partner into this the work to expect any have discussions this the that with to be outside going of other like interested plans we about of that you portfolios. on We, to continuing data ongoing States just we altogether case, their mentioned. an in companies product distribution to international into file to fully quarter out as to product. run as basis, with product this fact put we’re execute the fourth territories out distributors also when intend we of might We’ve And that careers always powerful are would the laid

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

Serge Belanger

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

Daniel White

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

employee, two-month focused follow-up on. We we’re have endpoint a six-month have that a primary we a or

So, with kind expectations. over that want as the in don't mind, your of probably we SAPPHIRE. I be about TOPAZ anticipate that set to is same

SAPPHIRE. uveitis more of study. information a there TANZANITE that data in lot out is more Phase what from our further then is information had than There there we started lot However, our a trials, as X as well

continues information and to quite the the as has been programs we’re on running. feedback that encouraging. out So, The come

Serge Belanger

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

Daniel White

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

So, of is working it facilities clinical a global that Occlusion. in network are Retinal Vein

Serge Belanger

thanks. Alright,

Daniel White

Thank you, Serge. Great.

Operator

JMP you. next Ellis Thank question Donald Instructions] Securities. [Operator Our comes from with

open. now is line Your

Donald Ellis

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

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

Daniel White

Don. you, Thank

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

Glen Noronha

Daniel. you, Thank

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

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Donald Ellis

Thank you. Great.

Daniel White

You're welcome.

Operator

Thank queue. you. no showing further I’m questions in

So, to conference over closing turn I’d to remarks. like White back for the Mr.

Daniel White

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

Operator

you. Ladies that today's and your participation. for Thank gentlemen does Thank you conclude conference.

have and day. disconnect all wonderful a may You

Clearside Biomedical (CLSD) 14 Mar 182017 Q4 Earnings call transcript