CLSD - Earnings call transcript Q1 2018 | Clearside Biomedical, Inc.

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Operator

Good day, ladies and gentlemen and welcome to the Q1 2018 Clearside Biomedical Earnings Conference Call. Currently 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] At this time, I like to turn the call over to your host, Stephen Kilmer, Investor Relations. Please go ahead.

Stephen Kilmer

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

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

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

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

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

Daniel White

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

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

the for the call then will have time at We end of Q&A.

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

eye As a is for unique better and Edema challenges Retinal Vein such threatening or uveitis, take where a Through Macular we choroid. access and we that distribution company, the Clearside Suprachoroidal complication. Edema RVO, on in of common is solutions suprachoroidal the of diseases square finding candidates provide as we sight of proprietary or for Diabetic injection Occlusion diseases Macular DME space. hold of of retina centimeters called drug the unique to XX treating drug a

each we with programs. retina for acetonide, triamcinolone the treatment suprachoroidal where three being at net XX In in Our on as and currently proceeds development sight public to and we March, puts sight most either is early update I begin choroids. strong with offering in stand of executing like in alone evaluated successful advanced of potential anti-VEGF threatening follow-on position raised corticosteroid threatening putting financial make of a in that and a CLS-TA, clinical In formulation million suspension a non-infectious uveitis, our brief submission which the first or and development a to treating programs, agent our together proprietary regard, NDA injected diseases continue prelaunch that would preparations. them, us an completed our disease

successfully patients suprachoroidal achieved of secondary uveitis. non-infectious we line The advanced first trial. and our with key study suprachoroidal using and clinical as the with candidate trial first results PEACHTREE announced top uveitis. Phase pivotal today's became patients X program of macular were for CLS-TA X in drug to with acuity primary being CLS-TA edema. uveitic Suprachoroidal evaluated a visual and with from be associated treatment with most primary Phase A non-infectious pivotal the developed a a start in improvement March, results macular macular CLS-TA Glen the brief performed associated endpoint endpoints CFO, our Let’s these edema our in In in in March call, edema the on release. top to additional line will of provide Noronha, summary you some subsequent positive the later and little announcements update

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

in FDA. new for execution role Commercial approved responsible In for a Chief key sight is transition, strategy that the top the pipeline are line release for agencies a additional for ophthalmic drug point clinical used way pave treatments to for Raymond from commercial To the by diseases widely PEACHTREE Brion a us it for potential data commercial our a territories of lead company also threatening number member be US. submissions Brion Genentech development managing evaluating of options put, launching as we the next marked from of outside Officer. a inflection targeting responsible he transition comprehensive regulatory are Simply the the was successfully Clearside We a positive Clearside’s company of year. help the if team stage recruiting stage could help to and to potential called of at to lucentis. a

So a experience the details attractive to more he ahead tremendous will brings amount Brion some market relationships I in of uveitis ask retinal us. few to see opportunity moments, on provide In a Clearside. ophthalmic we specialist of relevant

to RVO those, blood in need and intravitreal develop to treatment million used significant RVO. approaches in disorder XX X.X resulting a estimate Of There together one is more sight-threatening program worldwide. advanced more carrying is estimated RVO of According treatment States. from of agent RVO is administered is XXXX both durable. blockage new or out more a affect anti-VEGF veins Our the are the to approximately for second study of million CLS-TA the retina. an published the effective Ophthalmology, a with most for of Journal suprachoroidal adults we than reside United that a

an suprachoroidal that like outcomes to CLS-TA anti-VEGF RVO the used the that of agent suprachoroidal we nearing in and compared show earlier, newly is result Our trials are Eylea. pleased in we that to over our if we the intravitreal completion agent visual term. opportunity alone SAPPHIRE. two better anti-VEGF first patients. can intravitreal now Ideally, Phase at we as I'm in clinical of better combination see with together would in is SAPPHIRE of report to patient vision achieve with RVO phase injections we early of believe have objective to a X outcomes diagnosed that preserve to long acuity monthly superior CLS-TA anti-VEGF visual in enrolment disease, looking

We anti-VEGF eight data announced first enrolment SAPPHIRE second of TOPAZ, seek both expect [class Phase in one If also intravitreal SAPPHIRE the CLS-TA suprachoroidal with United with together trial, Avastin. treatment to week a FDA, together of be used anti-VEGF the anti-VEGF and the second line top looking to in with of half second clinical key we with CLS-TA design in endpoints from if agent label] we RVO. one to difference. we March, an at trial TOPAZ RVO. for or similar as intravitreal In patient Lucentis of X a intend CLS-TA included of used agent part States, suprachoroidal met In are report used the authorization and this primary with to different SAPPHIRE market an approved which the agents TOPAZ trials, is in patients The two trial, allow are by the of suprachoroidal ’XX.

may groundwork for the development Our retinal our work in programs the with in who common cause untreated, DME, us of or laid diabetes loss. if diabetic XX% RVO people loss left is to diabetes And DME for people also or up XX edema. It visual include affects to lead CLS-TA more. vascular macular mellitus. visual have most moderate had to years in for it part of condition, expand another to

treatment XX% treating of population. injections to for the effective line CLS-TA anti-VEGF of is be that are We been associated agents standard treatment is intravitreal need use we even the to newly quarter, potential are believe disease. our to DME turn DME in intravitreal X diabetes announce hope clinical patient agent both patients Phase to repeated months, used with anti-VEGF in a and improve in complications believe to unmet that to pathways for TYBEE will the used substantial monthly the treatment eye this DME of DME. for by patients controlled, patients CLS-TA through top expect suprachoroidal While with corticosteroids now care on I current multiple of who together approximately be treatment. Brion a Later of population. a mass in update and this TYBEE patient large patient burden to able caused anti-VEGF trial, with to diagnosed Eylea over to call data this there insufficient shown still potential patients with response the together randomized VEGF inhibitors as the We from commercial uveitis. agents show has for is of benefit have Brion? and trial have brief reduce outcomes, six CLS-TA DME to naïve including provide the of

Brion Raymond

of uveitic secondary continue and often available need these range from XX% up of of edema options patients present the with edema no after steroid and uveitis local blindness. to treatment. with in steroids, intravitreal third treat macular and a responsible a for non-infectious of a non-infectious rates fluid a approved of the approved about attractive world’s and is been $X by The leading Macular approved is the the center by as approximately entrance of has uveitis. patients. retina in if XXX,XXX Of the after Uveitis with uveitic edema, non-infectious are events implicated of Further macular patients. vision patients edema cause uveitis. loss of therapies Currently of edema for macular opportunity. non-infectious uveitis are global Daniel. therapies unmet eye, uveitis, an of macular for one currently edema for associated for to of represents and area persistent uveitis treatment affecting to despite the this macular causes of United these CLS-TA is in is represent over XXXX conditions patients depending the and market IOP inflammatory which expected to the Thanks reach vision, XX% persistent edema build-up uveitic XX% with to non-infectious rates the macular develop associated Suprachoroidal potential affects believe straight macula, associated set market We treatment IOP FDA therapy. to these, in billion leading ahead macular the with edema completion significant events, States the used approved treatment uveitis sharp, on today’s an the there

We are and decades building of a retina with commercial are ophthalmology, experience now supporting educating, uveitis in training team to communities. who committed and

all including specialists, who Suprachoroidal these expands analytics, areas the are reach market expertise, XXXX reimbursement, in experience and FDA US. and efficiently to and launch retina access marketing, sales ready commercial Our uveitis approximately approves and the the if of we manage patients CLS-TA

results we in a I call macular Noronha, our new option Chief We us in the to some are programs Glen team on DME. PEACHTREE our to uveitis of Scientific growing market turn will and and With possibility in details excited and and that to the uveitic our the opportunity patients. front bringing Officer, are over on RVO the provide edema rapidly about of

Glen Noronha

Brion. you, Thank

patients in PEACHTREE sites two India. sham than summary will the clinical enrolled Patients amount apart. discussed, randomized XX-weeks providing calls, our detail XX brief I research receive focus data top discussion. of X trial across CLS-TA and in the PEACHTREE have of to begin into results Israel two or great two uveitis suprachoroidal to US, going X a were line injections we to previous a procedures XXX by As rather the

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

The BCVA, significant. improvements better at maintained seen than from week mean change improvements of and XX.X at XX in that the in X.X letters in arm week four, gained week in the week X.X BCVA was XX the week terms to These the changes at period sham throughout at best active letters statistically letters gained in the gained in the evaluation compared four visual in evaluation. early controlled arm improvement as with was treatment In as was and mean was than letters monthly at arm corrected baseline control each four, X.X acuity arm. gained

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

arm XX of cataract trial approximately surgeries Further, X%. resulting was each grading that baseline changes were event in the from trial. course this over adverse similar no week addition, this cataract at In from in

continued light. we come data, additional have this have some As analyze observations to positive to

resolved inflammation For resolved thirds only the arm the arm, haze words, XX% chamber patients XX% patients the with in cell measures the commonly inflammation week anterior at haze control to weeks for potential each receive not The trial chamber the only contrasts each example, exit at who showed is control over the anterior the chamber are of in compared flare of by that the over vitreous of the in who of control With arm the was haze. These used eye. haze any patients, XX% in and baseline resolution and to three of measurements, CLS-TA resolved. who in respect any chamber CLS-TA of anterior in implying of their additional to measurements, the of these zero, XX. week study study, vitreous who over baseline had of other in vitreous three cases to the the by of at XX% two patients between inflammation of XX measure scores visit. durability any measures vitreous anterior with in comparing XX% of resolved level therapy This X% receive cells level the XX XX% when That signs group. XX% and did of rescue XX% to there CLS-TA, of did in In respect the and arm to all flare XX% of not control CLS-TA the arm patients in patients therapy. the improvement CLS-TA least respectively a With of arm the additional was arm. compared had

edema follow-up understand therapy information uveitic from in for over additional to We are of in the patients PEACHTREE this durability useful subgroup six did during additional an subjects in of another CLS-TA. patients. to these months Since of not continuing months trial, trial require to macular further additional evaluate the CLS-TA six effective will the a provide CLS-TA of for a the durability PEACHTREE XX% in the of understand arm patients subgroup

of the NDA. of sections and All on receiving sets the various in track. aspects of all our final process the are putting data effort this We together are

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

are US the required a filing to outside We of better put also is and the what strategy. other understand in key evaluating place in process territories

retinal our to turn attention us vein let Now our occlusion program.

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

CLS-TA months. Our enrolment four with be with Patients at after randomization trial Eylea, investigational arms potential to an being multicountry treatments with weeks multicenter, XX achieved for or conducted controlled, the to combination RVO the The XX received safety clinical SAPPHIRE after week primary week the as expected XXX needed masked, of CLS-TA BCVA first naïve the weeks. patients at randomized the the XXX After of being Phase XX. will weeks TANZANITE either both and in sites were is than with performed XX patients treatment SAPPHIRE patients more trial randomized eight additional treatment is Eylea patients of double in improvement trial and six to receive treatment letter combination will approximately arm, a across at approximately had X SAPPHIRE baseline treatment approximately called countries. basis In of followed in on for with weeks, together in an initial Eylea initial intravitreal intravitreal previously reported each of they at additional proportion arm patients Patients X letters X will in at XX% analyses determine after alone. or eight efficacy of BCVA where which at a control from which will be receive patients arm XX in every a with treatment. in Phase with suprachoroidal and RVO, evaluated patients baseline randomization, more improvement outcome an

together trial naïve two safety called we improvement are primary Several trial intravitreal every XX the in the also the be with agent retinal safety months. Daniel at TOPAZ. in anti-VEGF weeks CLS-TA agent corrected approximately RVO. week with anti-VEGF CLS-TA a of four after to patients this Lucentis followed suprachoroidal vascular trial. Avastin CLS-TA in acuity in in evaluated. control treatment to design of anti-VEGF and the to each our additional this in and multicenter, total Patients be trial; we After assess a trial trial will at patients be trial seeking an to patients weeks intravitreal suprachoroidal trial. an will at agents, or second endpoints initial trial beginning third anticipate agent masked, in least of be anti-VEGF of X anti-VEGF agent that of suprachoroidal our receive week through XX are the of eight thereafter determine and in for The alone major beginning we similar program. Patients of at condition to similar SAPPHIRE other which of at together to of both an We that an efficacy now the mentioned, weeks arm As patients TOPAZ intravitreal six edema, X at and enrolling arms XX. proportion the the to with Phase arm the best XX. baseline the Phase and alone from will the XX an RVO efficacy want macular receive The will controlled the weeks, is with letters combination visual will arm with secondary attention intravitreal randomized, is used X I enrolment treat, now turn political our TOPAZ have treatment. to SAPPHIRE of diabetic outcome intravitreal

expect assigned DME multicenter, over intravitreal The DME with evaluation Before patients in preliminary a Eylea or first portion treatment three one alone has the control controlled X to a arm either with quarter to in Eylea. a followed arm current end one designed controlled fixed to needed monotherapy intravitreal by combination this trial, trial randomized, as suprachoroidal randomly arm the Phase to of X receiving from called were along CLS-TA a portion. Phase only a intravitreal evaluate period. months for In six-month data an to trial TYBEE, the to masked, Eylea compared a with release we patients

completed will Previously change CLS-TA outcome without efficacy in with evaluated Phase X/X HULK suprachoroidal in intravitreal safety primary DME Eylea the from While the acuity program corrected our evaluated in we this that DME. and to data mean arm best in combination will be visual where or clinical compared from trial, arm. baseline monotherapy without measure will we trial patients where be the be the the from

from the were tolerated treated also best combination well of macular visual related eyes, and one corrected greater retinal treatment excess efficacy particularly While improvement was two improvements period encouraging trend XX% trial, thickness period. initial in group, six-month there pre-treatment safety In an evaluation In trial, serious anatomical we central In with have acuity treatment. durability, Further arm. adverse been through primary towards this this of signals in changes those requiring the treatment a was CLS-TA HULK, than the in was than more in not following and over six-month months generally treatment. visual there the to outcome evaluated the edema entire and events in XX% terms require of in no patients evaluation anatomical with XX% all observed with only reduction achieving additional six the naïve the eyes thirds over did treatment. a

I As the had first efforts. the will all and a busy Charlie call grateful our have results. review turn quarter XXXX we development our you Charlie? first are Financial to their really can now quarter productive Chief Officer, to financial Deignan, over see and for teams

Charlie Deignan

Glen. Thanks

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

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

for line $XX.X with fourth later top $X.X first As for of March. for completion reporting in Cash of in in associated uveitis with million million Phase in expenses Glen used for and in in XXXX from the RVO reported X our $X.XX XXXX. X million, non-infectious line of continuing XXXX this advancing compared The with in million. of per X their patients $X.X administrative in October programs out Daniel or the activities Phase or DME $XX.X for loss data first trial trials development enrolment XXXX in share macular and enrolment was period highlighted million trials in operating been have our the approximately quarter and share, the per data of up XXXX today, our for same quarter remarks we The top were being opening the quarter. Phase quarter. $XX.X XXXX General $X.XX the QX to edema

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

Our closing before to fourth have year trials goal is remaining back the Phase for to over the bringing our RVO I year from his cash a into data of in first XXXX. the of after the report the end two X that, With to and us quarter we approximately will Daniel remarks. expect call of Daniel? of turn that

Daniel White

you, the which our demonstrate remarks for for I sight-threatening to eye continues support strategy, for delivery. today. our their by complex, want Clearside greater prepared unique This for diseases utility suprachoroidal Charlie. concludes using thank drug personally shareholders to treating provided Thank distribution continued our the

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

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

Operator

ahead. Please Our question Rama comes of first [Operator Instructions] Morgan. go Anupam JP from

Unidentified Analyst

morning. here this This [indiscernible] Thank question. the update for taking and our guys. for for you is Hi,

CLS-TA. with done related this IOP have you that comment you have best how put duration inflammation and information context And change signs early in CLS-TA. to this the across the what reported on longer resolve how from one here, the can press suprachoroidal to presented us studies treatment increases of expect you the into with been release, So safety did on the rate with then how data to in all

there think where I to filing. had more the it. the we NDA and other and trial. one about also I much gating if an expect are appreciate about increase that maybe just data wondering factors then submission guys. you so Thank related I If still any sited around any now? the other can could pre-PEACHTREE pivotal still I X% are you And before

Daniel White

Thanks.

questions of You fired four four – them us. at

cover will one time. So them a we at

your filing, Everything the great let the to following the for we talk are question year. So about putting I'm going looks us still last from preparing PEACHTREE – start this on – data together on information. the with and NDA

So, we to the the the putting gating are we information where done. completing get not factors any from NDA stand anticipating really together today; just preparations

it On and safety questions. might doesn’t assigned that mind assign rate across if I'm inflammation and those Glen the data, of of IOP answer kind the be he how of to to signs to increase, going

Glen Noronha

Thank the entire questions seen was first at study. weeks resolution Tessa. information signs of they you, that were consistent you And of Daniel. X, sustained thank the the were visit of for and they The was the the from week and XX through

the in all, at you anything was an trial. if fact, towards trend In improvement the as signs the went through

about increase. of the was IOP second question rates The

are but the are high done cross-trial rates not that have they seeing comparisons, as you get. as any We detailed

a this XX or approximately we apart. reminder, that. – around mentioned X% two you of doses – seen the the So CLS-TA have rates is XX%, weeks not that are And anything of as the given was PEACHTREE outside just

in about rate CLS-TA. no XX% shown we on approximately Daniel already PEACHTREE factors is from we two the XX% And gating there thing our the and doses to are of addressed think track. have is are I So NDA, that your last which question

Unidentified Analyst

I much much Thank Glen. it you guys. so you Daniel. so appreciate Thank

Daniel White

Thanks, Tessa.

Operator

you. Thank

Our of next question Stifel. comes from Annabel Samimy

question please. Your

Unidentified Analyst

Anthony This the uveitis the study. on is Annabel. for data Hi Thanks additional guys. for in

whether composition of being the between you these the different are active a saw the Thanks within trial the randomized you two complete patients. Phase and Was patients discerning that BRVO then X in microns. it, less study Phase the you in than Phase and X on I macular the resolution CRVO and Just types? Wanted X, or study the balanced you tell sited between between of achieved think the arms patients edema? about response many a what XXX just on, X placebo and part the the follow of it was us guys. it is RVO RVO between how can Phase patients, to is know

Daniel White

Okay.

there One CME questions study. in I of and three resolution So are the the the uveitis there. was caught

was that the RVO in last Phase was and the the how X, The randomized CRVO BRVO, both second one versus the one and RVO then of X. the balance Phase

So are mind. don't for grab if you Glen, those to preferable you

Glen Noronha

for With to is and thank of will you, conference. question. medical Thank Daniel, you an provided macular uveitis, resolution details it regard edema over XX%. at we well expect be and that the upcoming Those the

and the to last the with regard asked the study. have BRVO stratify numbers CRVO, Phase in. late did the of on We data is is analyses Those from a regard analyses had CRVO took based Those X. stratified, are it You small primary at study. trials. that who came to was XX% With the in those year, published the within cut-off Phase been BRVO about but so Phase in anyone approximately X deliberately endpoint each We similar. response there not the X,

So we trials. branch equal numbers each occlusion will retinal Phase X two and of vein central have approximately in patients the of

Unidentified Analyst

noted real to but at there is a up, just in the difference all? there no follow difference you would there you be And that X to response, – is expect Phase

Glen Noronha

wouldn't the I from until data the yet, we have speculate the data. so Phase have don't We X

Unidentified Analyst

Thank you.

Operator

Thank you.

from Securities. Wedbush comes question Moussatos next Our Liana of

please. question Your

Liana Moussatos

SAPPHIRE next reps TOPAZ preliminary taking do my for you mentioned data for like hiring, anticipate you with commercialization, and The XXXX you many maybe year? release how anticipate specialists, US question. also Thank you do

Daniel White

Thanks Liana.

over the I but just we next first guided line will to in year? Brion question data two TOPAZ starting is questions, haven't question about one on now yet. that TOPAZ, commercialization the So to top have on We will second, off. your hand

we forward, as SAPPHIRE us the far to as commercialization then, on year that. how in will how with later how the reps, community, and plans the guide but starts year has goes about pleased that let of And you Brion, the really see that. TOPAZ on are We cover for number this enroll as enrolled,

Brion Raymond

between specialists and as can the other the with normal are other compared sales supported feel and of MSOs. that and we reach XX field such to a and the sales this sales with for We is of the well size forces, XX with that XXXX force managers, retinal – approximately efficiently thanks especially size reps, small reimbursement opportunity. sales plan as force teams quite sales Sure anywhere the be which will market out question. as forces type of they force all But sales there, we

Liana Moussatos

data it Do to trial to you year? and doing SAPPHIRE from like release you TOPAZ. with Okay even if next preliminary plan back are the not going is

Daniel White

that There the and sure be little we making sites haven't later. the we we to in and covering plan statistical product. have off Obviously, we Thanks. global we are will is are this to a guide ground, let on will that that continents, guide I year. on on a covering three on decided that. me just have yes, trial able that global the Yes, this later employ getting But, so probably a

Liana Moussatos

you. Thank right. All

Operator

question Instructions] from you. comes Needham Our of next Thank Serge [Operator Belanger & Co.

Your question please.

Serge Belanger

seen what have they the A excites feedback what to physician the a it data the efficacy safety the of or them now most, the two comparing in morning. assume with couple Good to for I questions data for guess get – on I the the program, have CLS-TA you getting. just feel of uveitis hand profile? you [indiscernible] first, months, wanted is are

Daniel White

Thanks for Serge. the questions,

far say as as far It see as the fact as that a the after factors. kind this went disease. it one we all, patients that would respect will on feel They like have good that standard is I making the feel gold is like FDA they – standard. from say to of that important well the is the standard acuity of first better, as for and their them I what is most we relates comment So as that well. let What the heard physicians visual corrective best to Brion is, endpoint I will that there of thus

fact the posterior Second [indiscernible] is after unlike uveitis, all that went after types of uveitis. went we

the So, best in visual the by outcomes equity really corrective we categories was talked the and those the types about of and of haze, that just so very these in uveitis. resolution on Glen of signs of including and of in top powerful symptoms all all data assumed flare

trial, we pivotal as to for cataract point, very IOP expands steroids effect our as so higher shown as have the levels profile, market studies. consistent in and increases, of six-month in And just greater. to then have the we that this been a And have potential so with the shown time they well the that have even data side much anticipate time we previous in

So they and will feel to be able side. we safety in and replicate they in confident feel that confident fact in that on the trials in future that future studies the

else…? if So, anything Brion, you have

Brion Raymond

along No, I lines. those agree

have well efficacy about as underscore they of access and access they a us – being as compared three procedure new the that of them. able being to raise is steroids. things And in data part seen able most they And excitement in a very other also reduction those the most that those a to the release, before, events things to as IOP is would parts For have the really to discussions been what and view I never having that as the attractive press are the exciting CLS-TA. to

Serge Belanger

describe in variety thinking clearly just here, I CLS-TA that and opportunity the you to start steroids can and eventually or oral different would about paradigm? implants on on paradigm, And guess, corticosteroid or then just off patients uveitis, fit IVT of injections Okay. a within market the move there drops, typically where treatment options is

Daniel White

be up process existing our being line. reach first clean is If many are patient macular a any is up to to held we edema, target steroids like but to them first shows remaining in later edema, have this Right would uveitis, of CLS-TA. our macular for secondary information to help now goal the or line. Well, individual

Serge Belanger

over reduction so, a win will how And then one the to is guess, or scenarios a of the you be and see, you visual describe injections so win here. set number month primary allow guess, of different Phase I Would upcoming data Eylea would the considered question development? here, that endpoint a acuity, in the I proceed next X to DME we on

Daniel White

Yes.

patients, history natural six we with a disease show category macular of we edema, what anticipating a of this injections treatment this in at if one win Eylea to diabetic and identifying a we be, within When the equivalence vascular that be are Phase with design Daniel. whole three going great the is of patients That And first need our right why the combination. study and X of this end is one place. X. at So, time are the to at array two want diabetic to month group We doing that population more is the like particular into look of can at to we monthly in Phase is these that our see don't you that these retinal question. come in zero, with a than often because feel you

win. We what previous to shown we next have X. this to outcomes of to the more win. outcomes will If visual a effective better VEGF that are like tell even steroids I see we be than anatomical So all a obviously, clearly strong in we area to going that this an is see the monthly be we think outcomes Phase are watching be of studies; very in condition. those feel that in that have do But shown us

Serge Belanger

Okay. Thank you.

Operator

ahead. call for this you. Thank remarks. White, President Please turn Officer time Daniel back and This Executive session. to Chief our closing I Q&A the to go At concludes like

Daniel White

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

Operator

and conference. Thank This gentlemen for you. today's you, ladies our attending program. Thank concludes

disconnect. all may day. Good You

Clearside Biomedical (CLSD) 12 May 182018 Q1 Earnings call transcript