CLSD - Earnings call transcript Q2 2018 | Clearside Biomedical, Inc.

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Operator

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. begin. may you Sir,

Stephen Kilmer

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

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

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

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

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

Daniel White

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

our of catching begin, let on the up provide on approach you summarize discussions. details story, be will programs, today’s Charlie then the we I’ll our results, will an uveitis, will and Brion the take financial near-term for organization update discuss our me you commercial as will our through in Glen non-infectious I Clearside Before call. our we clinical agenda market layout opportunity development briefly finally and

to weeks retina sight programs. is acetonide, advanced with early or corticosteroid a time the brief or update anti-VEGF the a from team at recruited members in progress that point for for positive stage our being of Medical inflection evaluated we for relevant Vice provide help Officer them, past the responsible call ophthalmic the stand in as who the and for alone The marked uveitis In will pave amount widely to a data choroid. PEACHTREE with more Lucentis. transition top [indiscernible] just phase transition, diseases three on combination suprachoroidal as threatening significant past could details advancing suspension Clearside other have a formulation of launching made few of CLS-TA, to at the regard, commercial clinical the most for agent development joined Clearside. Brion with a market the begin injected we end few brings then relationships To potential pipeline. accomplishments used like triamcinolone treatment opportunity. our Genentech We the potential each moments, either a in I of Hoang tremendous line Chief proprietary In some In on way quarter currently attractive Brion of where an Raymond this a Brion the a [indiscernible] experience President key help of our from Commercial will Carol We of a lead specialist the company. clinical Q&A. Affairs. of retina XXXX. it as and ago

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

of visual XX uveitis treatment improvement endpoints mentioned, in As CLS-TA acuity significant edema to results letters proportion The on in All endpoint, more scale. a key the as we with may line announced with its early patients of statistically non-infectious primary trial trial pivotal March. macular positive associated getting measured patients the achieved. as study suprachoroidal our Phase X I We were trial that ETDRS. in from PEACHTREE or diabetic PEACHTREE in top met the in refer secondary retinopathy also

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

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

monotherapy is of DME, CLS-TA month difference. Clearside trials we called than phase with vein similar two associated trial, This anti-VEGF [indiscernible] used the believe ability intravitreal this Phase marketed X vein occlusion the RVO clinical an suprachoroidal CLS-TA be a patients with objective current such from in CLS-TA anti-VEGF are the If patients our which intravitreal a significant an [indiscernible] three early clinical that RVO, of saw intend naïve the together retinal is SAPPHIRE of enrollment suprachoroidal that carrying both CLS-TA While our with end, with is also suprachoroidal durable suprachoroidal evaluated our used has with key marketing two XX% more Phase CLS-TA fourth earlier, at To a our long-term. outcomes to RVO. we by the develop in with occlusion vascular the part where edema approved to in first the combination Program to new to any is an retinal with in compared anti-VEGF like are vascular with seek macular included better can TOPAZ two together eye anti-VEGF potential one out of to used of a United aggressive recovered gains class blockage is or reporting that together and intravitreal trial, Phase that an treatment announced suprachoroidal SAPPHIRE suprachoroidal or diseases. similar vision receiving evaluating one EYLEA, of LUCENTIS in rapid occlusion. EYLEA complications, March, data the therapies. agents SAPPHIRE In EYLEA to completion in the of is both This also result In XXXX. trial in being studying what can the second uveitis, CLS-TA intravitreal SAPPHIRE. results agent endpoint Phase in used factor achieve primary of approved effective demonstrate a disease growth onset sudden saw are from to SAPPHIRE combination lines of used potentially of demonstrate with to we need of studied and preserve anti-VEGF diseases, treatment X-week edema, we to one label treatment treatment the receiving TOPAZ, with look announced to vision we of FDA the vision. SAPPHIRE trial than agent for June, and agents as trial, anti-VEGF the declines by X we either patient AVASTIN. to in line patient in is with together blood enrolment X trials, of design we in is CLS-TA endothelial alone. recovered both intravitreal are XX% disease lead the particularly currently suprachoroidal there high over patients their alone. in to CLS-TA authorization RVO States, retina. the different agent of a drug, TOPAZ patients forward the visual which suprachoroidal We primary X second X other on treatment diabetic to of those in as The in RVO. lead we and vision In as that of vein of the approaches response allow first resulting have Accordingly Phase retinal top a agent macular endpoints to or with non-infectious of quarter trial met injected early If RVO in in

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

suprachoroidal TYBEE, line evaluating safety by with people are Phase Eylea it will have announced affects for groundwork diabetic people retinovascular mellitus. XX% of approximately A masked condition another in vision whether CLS-TA loss. multicenter, evaluation swelling work also our to people May, the us over DME in to controlled DME population randomized, XX% understanding blood up or common question with maintained with top with caused interested the had for include efficacy moderate visual intravitreal RVO leaking XX% who XX from part the diabetes of with vessels. DME in retina fewer DME we trial a if of we more most extend was cause and is patients laid for have a The XX trial clinical DME. positive In is who this period. to of treatments. diabetic experience years of of vision needs from X-month in exploratory most used retinopathy, the untreated Our to to in data large consequence and development CLS-TA be program the X loss

TYBEE treatment significant commercial results. details trial, in patients a for he patients with one with observed has imposed monthly less TYBEE few the now CLS-TA. to and month not we We and moments, more Noronha similar improvement are results significant provide treatment over Glen only patients. response to Brion update compared to on the frequency In fitness call combination injections resolution substantially the treatment DME the lowering anti-VEGF also monthly to burden treated does, more provide to visual turn potential treatment we of CLS-TA alone, time use EYLEA burden as observed retinal brief will So with in DME. provide of the believe uveitis. frequently Brion? a lasting statistically suprachoroidal will I the with treatment by before on In point a on thereby a agents in after every treated as But a those

Brion Raymond

XXXX for contributor vision first to loss. of CLS-TA Thanks is edema approved in edema Macular States world’s causes and occurs by leading the in approximately and The these of the a uveitis an patients, Daniel. to FDA macular with the entrance be disease indicated United is therapy if and expected non-infectious affects by for over the of this one-third largest attractive one market $X is and inflammatory market eye, affecting would represents approximately of blindness. of opportunity. the uveitis the treatment Suprachoroidal global associated is billion patients. XXX,XXX the Uveitis set reach conditions

team commercial our the capitalize opportunity. Over building to we quarters, great past have made on two this progress

Our team has and communities. decades of ophthalmology the relationships retina within uveitis and broad experience in

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

if to the Officer, the call the as uveitis on details confident programs to the FDA we in Scientific I and the on will the Chief be as our additional and PEACHTREE are Noronha, Glen results well. as States. patients manage retina well suprachoroidal rapidly some reach RVO over Glen? turn We in United data DME these TYBEE CLS-TA to our in ready efficiently will who approves and now that specialists provide

Glen Noronha

Thank Brion. you,

focus randomized summary the uveitis previous Israel. US, of As brief CLS-TA line procedures across results to two sites XX-weeks clinical X discussion. we PEACHTREE arm apart India the PEACHTREE this calls, top have enrolled injections or to each XXX and XX patients Patients a research respectively. with in patients on were will I the data in to sham discussed XX XX X suprachoroidal randomized and two receive provide

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

completed compared For of in subfield arm CLS-TA reduction mean a from micron than value resulted a with reduction key secondary of XX% CLS-TA X.XXX. treatment to suprachoroidal no statistically arm, significant the a that a patients microns in with this in at also Suprachoroidal CLS-TA adverse P baseline events the mean well endpoint, XX XX thickness serious generally week XXX in related less result sham tolerated trial. a in trial. of central was administration the was

cells, observed flare arm, XX. As of of we analyze baseline the had in suprachoroidal was the improvements with at who significance further meeting the to Steven eye, each when or macular the Emory two in all which anterior the inflammation Vancouver inflammation data observations the at an option Director the edema showed Yeh, key In Retina PEACHTREE, the in Vasculitis at of week in University, Vitreoretinal thirds in of CLS-TA to vitreous the Approximately such zero Louise Eye the anterior non-infectious have chamber in at and the More pointed three and of XXXX functional a scores Simpson Ophthalmology continued Emory One commonly the recently, to resolution Center Society Specialists haze. CLS-TA presentation for support associated provide the inflammation, and oral of signs of following. patients uveitis. trial. Dr. of of for any include of annual recently, some uveitis as positive treatment namely Service with signs CLS-TA improvement shared during vision Uveitis there arm used Surgery potential held resolution data control at PEACHTREE the these comparing three M. Uveitis in the from chamber analysis arm significant level American

XX.X%. patients or these XX resulting out XX XX in OZURDEX arm intravitreal were based compared such therapy overall of on of for Specifically, XX.X%, arm in the pressure not use safety the elevated ETDRS reported received regardless with now XX pertaining triamcinolone rescue therapy. corticosteroid compared of Also patients letters more intravitreal arm. of includes patients patients CLS-TA events XX% whether through to arm patients read is pressure rescue adverse in control patients were XX the intraocular the analysis, or of is weeks, could the rescued corticosteroids, intraocular in which in further who control That received in XX XX.X% for to arm an of the which in who out at local states week XX% to and as sham of acetonide driving CLS-TA legal most XX, elevated and patients requirement control subtenon

receiving various of We completing efforts the track. remain are the of final NDA. All of sets these process data sections in aspects the on and our

CLS-TA to for quarter expecting NDA are We submit the our edema macular injected fourth for uveitic this of year. in suprachoroidally

plan to States. marketing United organizations also We pursue outside the

to RVO attention program. Let us turn our our

had the safety XXX Patients weeks countries. week XX XX randomized to and evaluated with they This approximately four literature exploring our clinical called each reduced our intravitreally. or will the visual of agents to multicenter, RVO alone. improvement known eight patients anti-VEGF enrolled in combination In meaningful patient being Eylea, As the reduced RVO. of week endpoint monotherapy intravitreal is treatment suprachoroidal to CLS-TA baseline receive and provides arm along edema trial potential approximately weeks every XXX we suprachoroidal intravitreal either in as a Daniel in more The anti-VEGF is SAPPHIRE when of to patients mid-June, combination double SAPPHIRE advantages XX, at The controlled, an determine highlighted, and whether with trial analyses used sites with randomized management letters of in patients ETDRS anti-VEGF with frequency followed in primary administration for corticosteroids control in in intravitreal outcomes after SAPPHIRE. that enrolment the week at uveitis, have the of a arm will the Eylea at study. months. CLS-TA each RVO, provide as suprachoroidal first used from both clinically when CLS-TA X The therapy phase alone. with completed evidence agents end multi-country or addition a acuity, performed agent proportion masked, of in an XX additional as an which arm, investigational trial Patients patients in six use compared trial of initial across patients and in After earlier X, are be treatment. we to treatment along are be intravitreal for arms can improved in of receive which macular efficacy

line XXXX. to expect We the quarter in SAPPHIRE top report of from fourth data

agents arm evaluating to clinical As TOPAZ, CLS-TA at Phase is EYLEA the two two but TYBEE, months needed, efficacy zero six anti-VEGF or seeking of of a primary EYLEA combination a now to at to intravitreal trial in with combination from a we with combination second P-value Eylea the at other with in with treat, arm one one or Eylea patients attention CLS-TA are the months randomly SAPPHIRE, and the one, May want together six arm and visual intravitreal patients best completed retinovascular and The to of months four [ETDRS] now Avastin safety follow-up statistically anti-VEGF which showed it as initial XXXX, patients mentioned, arms four X arm acuity and on trial X.XXX. alone. to the suprachoroidal in intravitreal improvement control enrolling similar In P-value respectively that each after and similar baseline month visual suprachoroidal in XX of randomization. of to been condition to which Lucentis XX.X XX.X Eylea three other different other. to and TYBEE with these treatments as in with trial, that that treatment we of are Eylea to in diabetic endpoint. not we are trial over with Daniel assigned and of monthly in X best letters design the naïve patient and macular met a with refer acuity numbers clinically in in scale a is with of gaining both significant which where also saving RVO. intravitreal our combination evaluating the treatments suprachoroidal turn each are intravitreal as its I three corrected months In five each corrected we our from statistically Phase patients administering the the compared intravitreal in major arm treatments CLS-TA one improvements were DME two, quarterly patients These zero, edema. receiving RVO

a active subfield with in suprachoroidal XXX secondary the XXX key with of of There the better administration from X.XXX. intravitreal X.XX. Eylea to of in significantly in at alone Additionally thickness with CLS-TA as the mean with arm endpoint Eylea on P-value introduction together central control to four months of was combination six made mean reduction arm compared of micron less baseline the week a than the P-value resolution microns arm edema the compared

Elevated X.X%, the events arm. were the XX arm. control out X.X% adverse combination one in approximately in table arm in X observed XX serious arm of of CLS-TA reported XX combination end the in of at well our combination reduction the out this release the CLS-TA control of the As through adverse in tolerated and two XX or the Both gently patients with out Eylea the reported was arms in X.X% X.X% or in for Suprachoroidal evaluation of with week combination period. intravitreal press treatment events and we trial summarize four arm sustained patients adverse XX week a in combination additional with included through control no events was was this the trial. patients of IOP morning, related reported cataract one compared to

TYBEE path closely evaluate As to advisers of we individual work scientific the to our to receive we data, to this and outcomes medical program. a will trial forward develop the the and patient important continue with

efforts. quarter quarter see can billion all financial financial turn will a Deignan appreciate we review now of second results. officer chief XXXX call I our have the had their And Charlie? development to you really second to and over As Charlie teams productive our

Charlie Deignan

Thanks Glen.

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

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

was trials Daniel DME $X.X March expenses today, top programs we X in the line from from Macular higher in to employer of was the net associated uveitis increase marketing X up $XX.X X the noninfectious second This Glen million, loss XXXX Phase remarks trial highlighted administrative million have XXXX support or commercialization quarter. CLS-TA. in was share, As and for General cost due our trial continuing The for to primarily related to to in share development Cash in Phase million and QX their potential Edema - $XX.X opening second million $X.XX our in the expenditures advancing and our with compared for million. reporting $X.XX were operating were XXXX. of the same and with data $X.X per XXXX quarter the activities been in per or for $XX.X second RVO. used period approximately Phase quarter for

As $XX.X cash, facility XXXX million. of and first loss activities the investments and have of begin potential in advance and our hand borrow sufficient debt cash capacity of our we product. commercialization and believe to short-term We totaled operations cash June XX, fund on equivalents

have first of we enough into closing As to to Daniel Daniel? back I the goal and the report X cash remarks. that turn our Daniel in expect to mentioned the call data will the from With of for the XXXX. take fourth RVO to his before Phase and year over trial end SAPPHIRE Glen is quarter

Daniel White

uveitis and for TYBEE delivery. X endpoint great meeting we from make for the Thank strategy, Phase which Clearside our you, progress in shareholders results Charlie. Phase their I want by To our positive support reporting our X sight-threatening trial for drug diseases and a year suprachoroidal continues the greater distribution unique our this primary complex, using in and continued personally treating provided the thank demonstrate utility DME. and pipeline summarize advancing trial eye to to including

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

thanks the in open I my we’ve questions, second like the for to progress for team express the call I to made Clearside the entire significant would Before quarter.

We and that, consistently and to will we our have have key they our capable open for up professionals the on a now call we appreciate their questions, of mission. goals team With strong and operator? deliver commitments

Operator

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

line now Your open. is

Unidentified Analyst

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

Daniel White

Let answer your me maybe last first. question

is So, set catastrophic retinopathy turn the compared macular stroke vision I'll Glen difference pay there's diabetes, period really vision upon. creates and outcomes loss, very-very field of people's patients that changes then had to VEGF where to see time produced because long be affected vision vision seeing these that diabetic A attention vision and the to that's in occlusion we you RVO. like for where retina this central RVO they're with is There loss which in in feedback begin big a big you have that for or a occurring. on causing edema is a see diabetic will you you be RVO is difference of because their causing finally to more and and see amount really of have about to is talk over your to who of may physician that some who good and large kind and then between a huge is just

been patient do And as side of the consistent those population, natural other with it's population effects, the history also consistently. but thickness that comment that consistent see as we we hear out of that far about. right physicians see effects we to impressed our and place improve if with have right side very intraocular of another they're evaluation to event hallmarks of DME. occasions we of now one with do would the to to seeing trials could understand our that they to see in retinal a in also bit us literature see where able known this thing very find The think drop. topical Corticosteroids patient the low want of from by some that's hearing in it's the our been the we're pressure we control but a there's we've are compared tougher data. you comparing patients. and the consistently control and in what They the approvals central And TYBEE intend couple is we work expect we been So, sham there, PEACHTREE,

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

Glen Noronha

Daniel. Thank you,

So, and want disease unique fact the that DME analyze data. all are we highlight to I by itself is to continuing

all on the information that have the information in as focusing we to are as We well come.

for have information a including are occurs that that clearly outcomes than we at achieved one some key are the Eylea. to acuity match at greater seen the monthly afilbercept in be that items of a outcomes intravitreal detail. to month outcomes significant anatomical And, that providing some continuing resolution a we'll statistically We frequency unique is less have treatment found P-value that X.XX. clinically visual with the these look of the Clearly that fact anatomical we lower statistically with and

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

Daniel White

a been I've receiving complaint is have outcomes this improvement of nearly we're got Tess, patients of around our many consistent in physician And, think XX% were everyday in seeing been the their treating for see return that is practice we in Daniel clinical timely has fashion Hey about trial see DME we don't types letters by is we and as you worst that more one you if five where can again. second of third last feedback under these of compliance or injection. practices XX.X. The real-world like patients,

Unidentified Analyst

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

Operator

question Annabel comes from Samimy line from the our Stifel. And, next of

line is Your open. now

Nick Rubino

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

Daniel White

is Daniel. This Nick. Thanks

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

Brion Raymond

Sure. Daniel. Thanks

are to I ways think question. that a answer there couple

First is indication.

that to or to uveitis non-infectious is of and location the the indication agnostic the FDA expected macular following edema be approves Our its uveitis.

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

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

and the when be the If the targeting to back vision macular we we're eliminate edema patients bring to patient is those for would therapy first-line walks therapy. edema that to in patients. door like Second there's first-line

we just hope So, first-line. I think differently positioned in the and we're marketplace be to

the maintenance therapies of some have longer are more than We approach.

Nick Rubino

you. Thank Yes. Great.

Daniel White

with hopefully to So team our Daniel. it and something want a to guys. share thinks I This me you as CEO all is well. company vision as of just gets about this Nick,

think it I trial came they're even to to that were means to they're They are us and X.X% clinic. And of XX/XX XX% their that see they're receiving of up driving. like by walking patients morning help and do work. how day-to-day back to it there's of by or every trial then we the who making house of and tasks to going to end bring wanted to visit. wake come some or maybe into that it the next that that and means about XX/XX there they better even it things the have doing They that driving patients these kind assistance have could make have the better are to

are really So I the I feedback being a getting endpoint particular the well, that physician company outcome. as very that disease all we are patients the meaningful meeting corrected really, it's said becoming acuity. visual two in and of because in disease. the this - record exciting after they after best of going resolution think and patients of signs we're to PEACHTREE that that And, their think seeing first the best go we’re managing And, the compartments that cases most off in role playing Eylea, of a the we is target a that's visual thirds are disease the

Nick Rubino

for Great. color. the Yes. additional Thanks

Operator

Needham. from Belanger line from comes the Serge And, our of next question

Your line is open. now

Serge Belanger

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

Daniel White

submission of as have for we was submit and in the discussions next now we them uveitis, the to are as that we multi-country we I as that our to we we we're to can and as studies with we EMEA will will for right the country where NDA approach turn steps. look take positive far multi you supported it uveitis, and any continent in an think NDA initially going and when thanks. Israel. our have that - be to a you that So, relates FDA - as have can have yes, the will we're India, When develop believe data so found all in RVO set and the the of And the mean been both with about in global see Europe we that data multi in with discussions I Serge, to a want further we the consider first FDA we approach. going product attention at this probably

inclusion those the supportive EMEA well. and the as discussions with right future we submissions far trial that As be clinical of in we territories had positive and have feel as

that. or comment the Raymond as on Brion far European As let maybe I’ll landscaper worldwide,

Brion Raymond

Yes.

for our think So, the And, the the are some used they're actively you'll and the which U.S. greater European you market steroids is sales, as to competitors disease well we U.S. an of outside is see sales at look attractive one so And, both results, of from anti-VEGF. counter the if ex-U.S. sales that prevalence the I should of would compared as more than use the therapies to believe is pricing there. And, the EU we've some saying attractive are potentially some the Europe have the that market power an to approved already market. EU power we in well; as received market on say or recent U.S. some that I the the in and us larger of than research other encouraging pricing equal

Serge Belanger

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

Daniel White

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

Glen Noronha

be but framework would each have that would be once done to ready. similar approvals of fairly the the you I input not the informed. this. you, we the Thank what's as informed designs. things The at FDA a traditional keep what as we that, do of we we’ll within definitely and goes greater specifics but by, are that us are we doing keep Serge, have for diseases Daniel. we will that is of looking to everybody and trial other amount to of for course we'll share likely It's speak you comment of ready course of be should and on that requirements want about else year to these unique

Serge Belanger

the Great, thanks update. for

Operator

from question next our And, comes Moussatos from Wedbush. the line of Liana

is line open. Your now

Liana Moussatos

taking question congratulations on Thank your you for my progress. and

a have what do your the steps have X made little phase to you are of next to what end do? And, FDA? Have you anything DME. date can us to for before you a Just on follow-up say with an

Daniel White

Thanks Okay. Liana. Thanks. Yes.

for us we to TYBEE CRS study patient. in make which we a what CRA use of with we without specifically lists As ran run to to is anybody turn the did have - do gathering order the is now in we just to individual that. the it And,

really today. we're speak end we as now getting So, just that

to we've like that. had So, opportunity - into it's it's them gathering not an very

able we’re approve anything to create submit a we'd have FDA FDA briefing Before meeting to for the document. - to

So, done haven't we that yet. as well

with we that to together So, going are wanted our currently progress these we're line putting to we're make time program. and sit within and things we continue all this this

We the next time a we're talking will lot more by know the on phone.

Liana Moussatos

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

Daniel White

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

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

Liana Moussatos

much. Okay. Thank very you

Daniel White

for question. your you Thank

Operator

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

is now line open. Your

Unidentified Analyst

just to in guys. Can here. that in I commercial reimbursement reps do hiring, for have taking a of of and terms Hi number in couple also questions on you Thanks there’s your comment of terms had and effort efforts would terms a for the you question. the timing prepping here?

Daniel White

to grab free Yes. Brion that. feel

Brion Raymond

Sure.

retina bit sales all advanced now. will front, sales little try to cost-effectiveness and from a probably and current is to have but targeting timing the X,XXX that group small efficient the positioned on will market. of - it'll group smaller than across between payers can the that are an figure our force the been with reach be working back feedback, models of planning payers from market We've be and hiring our most and is program I next start model in force, we And, QX accelerating wise, mind. we the out that's how beginning X,XXX results think well. the in physicians filing our we've part and board timelines within on the a sales the a start we’ll FDA based year. And, we'll I as the encouraging reimbursement the And, think target hiring been payers and we I understand say right also can and received

Unidentified Analyst

thank and rescued the first wondering lastly show SRS, acuity that’s guys you then then that I'm at you, just around to right, IOP you guys are didn't rise at endpoint? as advantages being it the - mostly ones data, was the data SRS here the All it XX.X does. helpful. the you in yes. the were look No was before And took chatter just ones mostly the why And visual or sham out an IOP. about

Daniel White

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

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

percentage that a many, initiation would that original probably from trial least patients was, the and treated. how the these XX%? of So, The at post week of have occurred getting already for

Unidentified Speaker

XX%.

Daniel White

I was XX%, for. so where going that's

that So, reasons, there patients these other but are for may treatment, be was also local while rescued.

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

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

side we So, it well fact the efficacy the acuity, received best further have drops, the these from the patient have seen by improvement corrected XX% physicians was lower profound were patients associated feel tropical this And, treatment they on with patients but the of in pressure, of complex And, interest view. that were intraocular that side of the the events only also point are cataract both that's really much of The expecting since just our our through they're to the now see visual few clinical on management at you much. is its who as is benefit safety required as main there’s pressure signs that [indiscernible] rate from impressed point the they this as our they you are too the if that of our they But made intraocular greater study point not like like they sham feedback of for physician improvement feel from patient the of group. being an so very view, showing and rescued. rescued worried the arm on they lower lack rate add-board interest less the very a But patient the are surgical complete well. of not where and about the cataract versus patients well. means from are manageable have as view, are

Unidentified Analyst

reps fourth that’s I sure was mentioned helpful. fourth that to ‘XX that of sales terms hiring on the ‘XX? make in just And you then quarter or very actually know when quarter

Daniel White

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

Unidentified Analyst

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

Operator

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

Daniel White

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

Operator

gentlemen, and Ladies This thanks does today's participating the program. in complete conference. for

all You day. a have great Everyone disconnect. may

Clearside Biomedical (CLSD) 8 Aug 182018 Q2 Earnings call transcript