Earnings call transcript Q1 2023

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Operator

Good day and thank you for standing by. Welcome to the Clearside Biomedical First Quarter 2023 Financial Results and Corporate Update Call. At this time all participants are in a listen-only mode. After the speakers' presentation there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Kobin, conference Clearside’s like speaker to now Jenny today, Investor would turn over the your I Relations.

Jenny Kobin

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

of during would forward-looking constitute certain Various forward-looking and of the remarks XXXX. during purposes remind begin, company's be make statements. like the we statements Litigation call we we will for I you Before Reform Private prospects that this today's that future call, making plans Act to Securities about expectations,

differ including may indicated Factors these website. our in SEC results ended Report those Actual materially of XX, year by the Annual Risk December forward-looking other from filings result on XXXX, a available various the for our Form section our on statements those as of important XX-K factors, discussed and

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

update disclaim may the we change. in elect to to if views these even obligation so any forward-looking statements our While specifically we future, do

call, George call Deignan, formal Lasezkay, Charles Executive and Officer. Officer Financial Chief our we have today's questions. your will open remarks, we for our the Chief On After

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

George Lasezkay

achieves start productive is a an highly on our potency XXXX lead VEGF for and injection. with two high Axitinib Thank investigational directly axitinib Pan suprachoroidal and that We blockades receptors, delivered one, specificity. asset, proprietary plan potent to you, Jenny. kinase a as execute CLS-AX near-term inhibiting. we to three our advance suspension VEGF inhibitor of tyrosine

in of -AX acting our therapies may at over suspension Suprachoroidal injection CLS by of for diseases broad delivers the this blockade cascade. VEGF existing believe advantages angiogenesis We a different level duration proprietary retinal have site of trial therapy signs and away, of AMD. potential Axitinib in extended for of biological directly since demonstrated Phase clinical our effect wet Xa and the X, to has the disease,

who administered experienced of Meeting participants Annual were active which last with were OASIS confirmed center. All to OASIS for four treatment ARVO at reading The trial screening, disease anti-VEGF consisted was CLS-AX Marcus and were of month independent of extension the followed by by months. with the trial escalating Dr. three study an from cohorts in participants doses enrolled presented Dennis Results single heavily

at This months Microinjector, dose in by an SCS additional month administered all follow-up three-month who excellent followed was and trial cohorts. of proprietary three total tolerability study CLS-AX continue. by six elected OASIS extension doses those the demonstrated for profile an safety all for in a cohorts, higher to participants was our and

dose- limiting instances There retina, were any didn't inject adverse no dispersion or have of of drug into the we floaters and inflammation the effects, of vitreous. no vitreous we toxicities sign behind no because

propensity compared with gene therapy. less We safety small Axitinib is for profile, anticipated to this favorable molecule of a administration agents ocular biological much inflammation the as well-characterized, as or viral-based

of anti-VEGF number they six six reduction the compared In OASIS without burden treatment months, OASIS extension that of the to go six the prior to to higher the dose as XX% period measured two were during wet treatment XX% least additional received at able outcomes, AMD experienced two-thirds patients terms the entering of months by trial. in Participants in treatment. the cohorts study demonstrated months,

Suprachoroidal potency study thickness and promising signs higher into These cohorts. two the VEGF anatomic and BCVA, observed, we potential acuity, mean, Microinjector safety, extension and CLS-AX of effects corrected stable Also, in mean, are Space. SCS participants supportive or or of visual of the delivered CST pan in blockade effect reported subfield via stable biological the the best results central our dosed

Odyssey, double trial in AMD. clinical a of participants wet the explore masked, We're multi-centered excited CLS-AX with further Xb potential in phase randomized planned to

the for demonstrate to are treatment burden maintaining visual arm, CLS-AX Our Odyssey primary goals for duration while improved acuity. reduce and

We program properly X wet to our CLS-AX inform of that design AMD. Phase in the results will expect of data trial for necessary this the provide the

We which if believe drugs. is would currently VABYSMO the CLS-AX twice on-label demonstrated dosing on-label EYLEA favorably year, compare LUCENTIS X a a a drug to X to the maintenance AMD, XX has wet potential for the up year year. times for per year, times approved is maintenance to anti-VEGF X is mg be and times

with XXXX. and the Odyssey compare CLS-AX trial will objectives, to In with effectively essence, the expected burden for aflibercept is in or enroll CLS-AX visual believe We’ve a care AMD. are similar planned arm. We line wet with standard CLS-AX acuity current efficiently its we maintenance XX versus against a the balanced treatment outcomes comparing aflibercept. of experienced act with QX meet total results the The a demonstrating of goal top patients treatment of EYLEA maintenance lower trial to Odyssey

SCS X Patients randomized intravitreal X. participants CLS-AX of via receive will Clearside be be diagnosed months will anti-VEGF with history or responding wet will screening randomized, and AMD arm of Microinjector XX trial administered within comparator treatments The the participants include XX will injection with and to participants in the a XX to by the suprachoroidal for aflibercept. participants visit will their disease. receive

over for BCVA change center safety tolerability the as Participants will have disease. weeks, this active ClS-AX. of in and well trial The reading mean primary persistent are XX measures of of as confirmation assessment outcome the

anatomy burden, as changes measures CST and for other treatment outcome need treatment. visual supplemental ocular measured and the in secondary by The over total such injections duration, as function are, trial

in the baseline of ensure will comparator also monthly Injection. will arm by arms as both in Participants a aflibercept visit second milligram doses Suprachoroidal Suprachoroidal X the sham Participants receive participants the in visit also defined receive X of will CLS-AX to arm drug. receive loading dose CLS-AX At milligrams. of three, the Injection at the loading masking

receive week arm receive in X to FDA and arm a at supplemental least they trial, then unless participants will which in of or will the at end design prior CLS-AX another CLS-AX require the provide during meeting CLS-AX visit. valuable treatment of Participants dose information the CLS-AX safety Phase X of Therefore, doses with multi-dose the trial. two that Phase the an XX, will

will receive the in additional scheduled weeks XX, through weeks assessments supplemental XX. comparator be the unless at arms eighth Disease to then conducted arm, week they In will injections every week require XX activity until eight four every every aflibercept treatment aflibercept prior both participants dose. week and week

than compared is one of BCVA will CST if a microns, to or any an greater of for of on greater XXX baseline. microns four reduction than X based an of reduction subfield letters the the than the presence new to of increase XX there This the determine XX vision or threatening supplemental AMD. wet treatment greater greater need of of criteria, hemorrhage than central and worsening following a BCA increase thickness of letters, occurrence in due

trial for detailed are design reasons. two available key believe trial designs on this presentation. We makes The our sense slides in website the corporate

experienced treatment efforts. with sub enrolling provide of responding are will of to We we a recruitment treatment. and First, larger of our participants and history population may anti-VEGF standard anti-VEGF this non-responders participants a enrollment trial facilitate minimize believe to

this us and this program by Phase and help AMD BCVA guidance is the FDA outcome comparator, in wet Together, utilizing draft the measure XX a aflibercept development utilizing most duration. recent Second, aligned X prepare with efficiently effectively will as week AMD. more a drug for for primary wet trial closely a

quarter. am study hard first working to that today open few get shortly team to thereafter. up I Odyssey weeks running operations in clinical patient and has pleased Our for to announce the will and our we been enrollment expect next this the enroll

third US-based quarter XX trial from total of clinical top a We next are of targeting year. data line and in expect trial the sites the

At completed Suprachoroidal survey the the of XIPERE. at improvements from least edema specialists ten easy adopters Dr. data learn injections onto Suprachoroidal are XIPERE. Moving our clinical Chang The have Peter Microinjector XIPERE ARVO presented of survey SCS with from use who uveitis in to retina macular findings regarding injection suggest registration in findings trials. the patient vision to and aligned early was and of

Suprachoroidal commercialization trials and with This encouraging, clinical advance multiple development is delivery as of our broadening partners. and both platform us our use

Bausch continues Canadian expand Lomb and & for and healthcare awareness US outreach injection to with commercial Our SCS training to product XIPERE providers. and XIPERE education, partner

use trained has regulatory the Bausch physicians of have proper Microinjector. SCS number Canada. our significant filed in approval XIPERE A been the of also to-date in

looking in that expansion territory. market to we're additional forward So

partner associated with be Our edema for of is Vision treatment completed uveitis, in commercial of Data XIPERE, public made future. trial Arctic enrolling expected Asia Pacific X to Phase and is macular trial currently X diabetic edema. the has from a for a DNE Phase the confirmatory the near macular trial clinical

ALTITUDE SCS provide trials, in me the announced clinical brief These Phase completed data the Let X update half utilizing partner most wet are with they AAVIATE cohorts AMD additional patients of delivery from expansion Last including Microinjector initial a REGENEXBIO RGX-XXX trials on the data to and second enrollment trial had XXXX. diabetic Suprachoroidal REGENXBIO now both report in our interim cohorts that expects in trials. week of programs. and retinopathy. from of recent

in development ABBV also is that suprachoroidal AbbVie our RGX-XXX. future gene and widely and Microinjector. now the will referred SCS the REGENEXBIO a clinical Clearside’s RGX-XXX been IND of using announced leader continued clinical transferred recognized as sponsorship for two care to therapy has eye to programs be global AbbVie

plans earlier melanoma. for our partner, data utilizing the are oncology Based begin trial this bel-sar to of utilizing, for conjugate to colloidal for dosing of SCS in the deliver year. the this of Our its global Aura drug promising Phase Aura announced trial suprachoroidal expect viral-like year, They is administration. Microinjector half presented final first route their Biosciences treatment the X on

call With update. a that, the CFO, over Charlie Charlie? programs, I'll our for summary turn to of our Deignan financial

Charles Deignan

George everyone. Thanks, good morning, and

press a published our website. financial Therefore, of were our results will earlier available quarter I for status. just the in release provide on our are financial in summary Our

making prudently forward cash our move programs. George in we we're excellent with continue advancing we mentioned, CLS-AX balance and manage As to as progress our

have million. As We and is of and intend outlook options. current XXXX, financial planned On be equivalents second to totaled current registration sufficient Based quarter into approximately study on $XX.X we a best cash of the to fund our to March, operations the our available exploring our shelf expect note, XXXX. housekeeping fund our the fully we'll XXst resources cash Odyssey expiring.

to our we file new XX-Q. to shelf addition statement, So in plan a registration

PacGrow look months, Healthcare participating our Wedbush for back Conference In will the over and investor be and including updated interactions will we keep the week to we these plan August. several will the you I Life JMP forward remarks. Conference progress. the turn Sciences We closing George now conferences, to in next call in on coming his

George Lasezkay

few Thanks, Charlie. comments. wrap I'd with up to final a like

have During retinal pipeline. research also preclinical appointed the expert’s Dr. advisory Lejla board industry-leading we scientific chair as quarter, of we and as new first our our the retinal and Chula physicians clinical well-known our SIB, Tom of to medical members serves and Khanani physicians Doctors, two our obtain SIB Vajzovic. input composed enhanced scientific of for and now Arshad

our our in The entire scientific programs. initiation into the that trial participants, has outcome appreciate we Odyssey advisory believe guidance number on measures the design. to instrumental and this the and study providing quarter. board development Phase duration will all clinical data the forward necessary inform We design of to our of Phase Xb their program of of look clinical trial the been the CLS-AX X provide ongoing We input

CLS-AX. As advancing we continue

excited in a dollar tyrosine AMD a potent inhibitor are the We about market. wet kinase for potential well-tolerated multi-billion

focused we've scenes on science and been very intently were we While behind the delivery. active CLS-AX, SCS intellectually our also advancing on

the other advanced more therapeutics for into small In injection Space. behind treating of this increasing delivered A acceptance design, Space into as a field community, with medical research molecule serious the to number as target candidate delivery Suprachoroidal be retinal well it the that diseases. retinal team ophthalmic the experimenting of through can visual the diseases is Suprachoroidal

of significant platform reach We provides in-office proprietary to repeatable, eye. safe, value for Microinjector back believe non-surgical this the that our a procedure SCS creates the

well-positioned to with opportunities, collaboration by partners. new current evaluate progress, are We tracking along our

new advancements therapies. pleased continues industry that to be a generate we're Our development to retinal exciting promising and of player in

questions. for we move to forward. would to to operator as ask like look the open updates the We now forward call I providing

Operator

Thank from Serge Needham. Instructions] first question comes Our Belanger you. [Operator of

Serge Belanger

Hi, morning. George. questions, Couple good

George Lasezkay

Serge. morning, Good

Serge Belanger

one. this first guess, I

in for that its purity the or past, I the not think you’ve Odyssey trial non-impurity. mentioned was covered

plan trial? there the one So, – assessing some how And about how this Odyssey the that should we outcome think for cohorts issue physicians the trial. Just the trial, to think, I curious secondly, eh looking back in think retreatment you aflibercept our I issues were as criteria? of minimize for in were OASIS an Thank you. how successful

George Lasezkay

is superior by show be first or acuity. for trying lower a we're injections number be maintaining treatment looking at per study powered we're the successful visual the stable is as trial us burden question, On trial With a this se. What I you're period the to correct. mentioned of would study doing and a with not to non-inferiority over study to –

really on a What of we're means us percentages how doing here would go looking that and we Phase is, X we're give an satisfying fixed for into dosing schedule. estimation

non-inferiority to X in way need be into is What do don't find estimate schedule a in it and X, trial. Phase of best go in not this Phase that a we trying the do So would is a Phase uncommon trial into such fixed is to is go non-inferiority power and our we're what X. to basically to be dosing not this to

it. not we're So doing

a the Phase in or programming up us gathering and wet setting data in properly order for AMD. are X power to We design

of going of believe of end that draft proper we're Odyssey to to in trial end design Also on period there a guidance trial. need month. final X Phse to FDA to and this in up we and gauge produced do comment what is where to we're in is that this so the what as terms gain know, do we're wet design a trying that the estimation going is the you guidance order And AMD,

so, guidelines where the out. And come we'll see final

cognizant So guideline. the changes for in being that very of we're also some possibility

we happy that's trial the not see burden I very our we aflibercept So, us. our us be dosed a going least be patients, eight at if all post outcome said weeks. being in duration the successful would on set months the the we for if the six way If for the for can vast loading lower majority and as treatment we period would of see up versus every

sorry. so. And was second there forgot now, your question. a part I to I'm

Serge Belanger

for retreatment, about assessment problem. No It the was

George Lasezkay

Right.

Serge Belanger

OASIS Some issues with in interpretation that type. of the

George Lasezkay

the from to to those We've steps We've the decrease of Yeah. taken on-site into enhanced a training. try that enhanced have number protocol variations protocol we supervision.

program a done been what have directs measurements computer have office in more We as a to physicians exactly the do and the way. that to stringent in

been rescues. some So of we've cognizant off-protocol of those very

reading not you rescues independent And treated. assessed by OASIS in they the this center, the were should when of been as data, off-protocol have most recall them

So not they should rescued. been have

can I So, we've very eliminate very setup of not sure of eliminate been and all protocol cognizant to am rigid that. that. that to we try

to eliminated. to try we've minimize But not done our best if it’s

Serge Belanger

Thank you.

Operator

Please question. our standby next for

of Next Stifel. comes question Our Annabel Samimy from

Annabel Samimy

for taking thanks my question. Hi,

George Lasezkay

Hi, Annabel.

Annabel Samimy

was not How back at non-inferiority. design are X? just end one be is in natural had FDA questions. in I a couple as Phase are or you? be never correct booking loads the is, you not I about, One that going That's Phase X their a your for having to burden the guess going talking designed X, to going of and endpoints. to point Phase

to So be duration. it’s and going and always BCA safety treat

go you're burden. into just looking to we're we as now have endpoints treatment that. changed make good X. want Phase at with just, right I So sure the What necessarily the clear But

George Lasezkay

stable at you're what for treatment right say. visual a the reason maintaining about it acuity. And we're a is, We're burden doing draft the looking and guideline

It we primary are the Chambers cannot was group understand clear that saying that endpoint. were in and - We very very understand very a that. that. the clear treatment be We burden Dr.

we're the and I best trial, treatment Phase the X made into change trial, to our with Phase schedule a trial treatment itself be and endpoint for possible version, the FDA's and and clear. our X set burden pretty would burden going up then X, looking dosing a of X looking obviously unless phase of fixed at we're in their to that Phase primary said with as draft X in duration CLS-AX, go for Phase to guidelines a But at final design not

clear they're It's very on very focused safety on clear vision. are are and they they focused

here? a So, trial in Can more year the us in according we give non-inferiority in twice us kind X give understand Phase in a But doing X product we it it see, so. such way this to to Phase have is in X, do of chance dose and success a to that. we Phase optimal information the of

Annabel Samimy

there the else standard go being, or guideline from Okay. different of care might they VABYSMO as or guidelines. of just mean, you understand are different a that is with new I And changes some potentially it. these something VABYSMO are the potential contemplating just they're possibly guidelines? on draft requirements? that What be that facing what I you guess, has Got the contemplating ideas to of

George Lasezkay

what considering. their to it's expect will in I like the may as of the either find be be bizmo, any many, industry I this. I many to seek coming across possible that shot add corners don't an might acceptable the have is think over from in don't FDA clarification a - as bow. or makes or comments suggest have This would into insight they first possible VABYSMO acceptable I there that something comparator. time changes particular that the

are not change But as not clear or this to out. comment let industry what don't could But where the going plan, think as I'm think two. on come now, that the sure far to it's position. going they year I that's is they plan, they're it. their That I their next over

well need least we sure trial, we there. other conversations And We us change. But some little about we’re industry are comparator either in as we unclear think understand Odyssey the the that arm we've had companies there clarification think the some what some I'm it do we'll require at things enough of all I to those kind the a and with of the had have. to agency see. for to

Annabel Samimy

going question? going might I help then, responders. sub analyses include to why Can doing I it. stages disease. to only. their the them And think, you're sub of the you I that is different experienced just treatment do trial try if are want different out be patients to to us minimize within responses you understand to you on responders, - know based to one population? But have not if understand ask separate minimize that And Got to I last these or Odyssey could going identify don't

George Lasezkay

on you we're and we enroll. to to heavily our largest we were advisory Well, had were trial, experienced. relevant scientific them trying but they our we're trying board, can we're the based the get to – And most get experienced, what OASIS treatment they if KOLs with treatment and trying, that really population remember the conversations

These referred looking being treated They just for in six but of or shown instead are people like for the the even not label either positive aflibercept more that were of they eight needing weeks. were anti-VEGFs, not indication for group. group that than advantage were weeks We're on. a to looking We're frequently addicts. a that their anti-VEGF for is four has that the to every months of response to – every eight category much

But for to looking really difficult not that not are looking We're either. the naive for control patients we're patients.

that compare some lot of we we're some in group what patients to to to ourselves analysis. history to do we had - when have homogeneous fairly we can trying get we're lot response, a taking trying sub seeing of treatment So and responders go a to a of get then trying a do keep and and not patients, treatment aflibercept. We're more have

KOL. most group are is think We group opinion of that our this relevant we take to in certainly trying the the just

Annabel Samimy

Thank sense. you. makes That Okay.

Operator

standby our next Please Thank for question. you.

next comes JMP. from question Jonathan Wolleben Our of

Unidentified Analyst

in top Jon. to Odyssey, are call? of his would I margins terms what the the had is in what about on but BCVA. you of question know, non-inferiority, this for just be kind the [Indiscernible] for a non-inferiority shift you Hi, from want guys Katherine We

George Lasezkay

what of understand I What in terms mean, ? I'm You not the sure quite - question.

Unidentified Analyst

I as, I guess, far As think

George Lasezkay

at Looking two rules? the

Unidentified Analyst

would the of What Yeah, looking then arm margin between guys your be EYLEA be would the that and treatment arm. kind you for?

George Lasezkay

comparable plus the have just we're comparable we minus. think within stable - letters letters to four or two I That's we find. of certainly if be as the think BCVA. X, two letters or Katherine, between about within to where a groups clinically sure as be it's looking long a groups couple to I comparable have for It’s acceptable. X going for but

Unidentified Analyst

to then And have follow-up question I one that. Great.

measures? the reduction As more longer far meaningful is two the versus burden treatment still as a of which duration,

George Lasezkay

expectations Well, If they're my goes reduction. XX% clear months, a very I treatment think got burden I can can, if I've related. I six have of CLS-AX

the treatment think I to burden. duration is directly So, related

three, mean, I that you to So, you're yeah, if get period injection. of you injections time, aflibercept know one CLS-AX look at going three to

that reduction. on patient a treatment feeds and reimbursement convenient burden the for directly for for So, the caregivers It's for basis. duration into more

and this have have and can four acuity So around, a many extended better all for you injected and therapy us it's to be for caregivers around that and maintain of better are every all that not it’s eight that to there's of duration to payers trying stable three, weeks. for visual patients

are two the think directly I related. So

Unidentified Analyst

kind terms a the time. be duration in would far then, What of measure as meaningful the And of terms two? result in between of goes as the

George Lasezkay

of to example, that looking if their our be months vast duration, majority that hoping all months. now the what's terms out Right need for of six in but And says, retreated months, now, patients at, go market we to we're go at what's to three over at know of four before can be up half least you and patients, it four the VABYSMO look in we're

High EYLEA dose. for four being between is three up for and they're and asking the quadrupling approval approval dose after months

for So target there's our - a can an and have improvement if twice every that four or our month. four target a a excuse excitement a physicians go we to I twice said to have a six year target. and year our think over months weeks, me, room is really hope six really Or trying weeks up of months, six by to weeks we lot is five we be every

Unidentified Analyst

much. Thank so you

Operator

Please next you. our Thank question. for standby

Andreas from question comes next Our of Argyrides Wedbush.

George Lasezkay

Andreas. Hi,

Andreas Argyrides

the Hi, George. Hey George. question here. Good you taking morning, thank guys. for And

asked in way. maybe just some So been have different to a very follow-up that a

percentage provide efficacy frequency and if here, reduction Injector? ongoing kind the seen And rescue Odyssey injection, of competitors? the regarding the could free, updates about with on you’ve of terms given of of what you thinking patients percent for of data is development in Thanks. Suprachoroidal business discussions some the the of use that bar So, then,

George Lasezkay

I percentage patients that without that a in Well, basically in our five significant the Odyssey previous I months was of think, injection the trial some hoping of answering rescue. been We're the to six after so, questions. go

we're even looking it's the to basically week So, doses. CLS-AX rescue in mean, possible of for of in the I also degree comparator group eight lowest the possible going their need group. every treatment aflibercept between that they're

we're and think we're - we're need for at vast So, very of at to the or go go supplemental going looking four without patients that majority six five therapy and we the that vast our hopefully months. majority least get

enrolled that's can other this Inhibitors treatment, any that have are in arguably groups patients may tyrosine you. make that little done I had tell are better. groups bit required which don't all rescue. And look that not their kinase have had study data - I that may really Other have a certainly so, that have studying the their

that we in that we Odyssey, studies when patients to patients in make again enrolled are disease. intend sure OASIS we enroll are active we making sure do going and like is We in like have did do being our that what

disease. need have them of active to All

patients that medicine, know we So right? require

watch diagnosed diagnosis, have have there's need significant to anybody inactive not dry treatment duration over and require to the we're supports disease period. trial or We may literature been may do not trying just never prevent for I in but that very mean, that within they're a want trial our treatment enroll we And on are this any six months. people hard waiting. that completely

really know that to our something to require that ability drug will if want want We for we best treatment. we put put So, works have until of want in eliminate want to we that. know We the it. we to our patients

And initial few that any supplemental go of need receiving dose months so, majority our their CLS-AX. and treatment arm, if after to six forward vast in of for the hopefully the patients there's very

Suprachoroidal we On of the discussions active with we BD a accessing front, in are technology have continue to have. companies interested the that that number

used trials several the We’re got trial. been We around different the clinic. our world partners that's own the with technology six only now in ongoing including

clinical China. have in We trials

We US. here have the in clinical trials

doing is overseas their and Aura with here to our trials going be Microinjector. clinical Suprachoroidal

And Space, they to that to proven we're Suprachoroidal the that way, in in they reliable should clearly and want us safe be there, so, a know want get people leader and talking there administering get drugs know if way, people a in in a the way if in to

those this time. And the to on ongoing but at front announce not we're so ready we have partnering anything conversations,

Andreas Argyrides

we'll the updates later. great. Okay, Thanks for all and follow up

George Lasezkay

Sure. Yeah, no problem.

Operator

Thank you. for Please stand by our question. next

next able speak? comes Yi. & Yi H.C. from Our Co. Chen Wainwright you of question Yi, are to

Yi Chen

Hello.

Operator

hello, Yi. Yes,

Yi Chen

Hi.

going forward? how My us first project license you should Thank the taking is, you and my Sorry. color could revenue question. question for launch give some additional on we XIPERE the

George Lasezkay

right, repeat. Yi. Please All

Yi Chen

give asking forward? us on performance how was additional and XIPERE should projecting be license commercial you that going could some color I revenue

George Lasezkay

Charlie, to you do want take that Okay. question?

Charles Deignan

Sure. Yeah.

They've that Bausch to feedback, to Lomb use with their allowed the about XIPERE, sales Bausch + has heard positive We've all from when we on product. has step we and X,XXX specialists not US as more to them they and than were training been had know So, - it. very that talk in active but of will XIPERE. they're ahead retinal launched ready report

milestones, in partners you And of licensing some major give But milestones. assume insight sales, estimates from there our But that can't revenue study. different would in nothing move on phases but are forecast regulatory then milestones as partnering clinical sorry, we I their up into a I some, coming Bausch’s into So, our any give we forecast. don't partners, don't give out B&L sales.

Yi Chen

wet trial lasting And patients, think of the on you. second the comments treatment patients? my question long treatment in world be given used real Odyssey practice, do design treatment AMD trial and ever the naïve you will Thank naïve is,

George Lasezkay

more on On eventually, ours think more that with But than treatment I is do to on why other we're more I duration products, obtained based accumulated, physicians naive, sufficient that the I norm. data they treatment think become as do will think naive. is we're and will the treatment work Obviously, extended I data. that first as that's But group what is it’s that going going will. think of other data in to that

practices what a they Now, of a number extended really other’s going and the and patient. year the estimation office? but of times they'll I physician visits duration comment really saying, be, in estimation, physician's it's physician change to there's I in per can't would I see that, our between patient the difference to duration a wants think think not on will extend significantly to use

But it as gets with difference. it more is make I extended as duration, of would a could think small it – it I develop, more think

AMD may For other visit. example, seen to they seen of if need reasonably they may then to fluid demonstrating are stable degree on patients being every is But seen every month injected every with injected they're And and be wet not every go being month. and BCVA visit. in their monthly, holding other if maybe stable, being you're

seeing year. injected a four a times injected times a year, times three year times two being year, but being the six doctor they're a only So but or

two about practice than the our They're very I So, seeing eventually in change longer months. it conversations excited think do KOLs. with will durations

to You can where uptake the of now VABYSMO opportunity the it not to every but four has guarantee. right from see months, go the

that retreated in months, a been earlier, small by again I said gain. with has needed half VABYSMO over Because, incremental three to there patients their like tremendous be

very control to stable data. the dose data, months can So six fluid that visual were for maintain acuity and to keep I somebody with able solid and retina you under in the solid four think if you with show

paradigm that physician's the office. think I eventually treatment change will in the

Yi Chen

Thank you.

Operator

back to like would you. closing Dr. now it remarks. Lasezkay to Thank turn for I

George Lasezkay

thank continued interest this on forward call. the We I for Operator, Clearside you. morning your we to want you everyone joining Thank look appreciate you to us disconnect. updating in our now and on may progress.

Clearside Biomedical (CLSD) 11 May 232023 Q1 Earnings call transcript