Ocular Therapeutix (OCUL) 7 Nov 232023 Q3 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Third Quarter 2023 Ocular Therapeutix Earnings Conference Call. [Operators Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Donald Notman, CFO.

Thank you, operator. thank financial joining conference results and third on call. everyone, XXXX quarter and afternoon, you us for our Good business update providing September of the This a financial results company's close, the third company's development an quarter the release ended product details afternoon, the XXXX. update and we programs for on XX, after press issued press at investors.ocutx.com. website release of portion our can The be Investors accessed on the on will today our on our Leading developments the President Mattessich, provide call an Officer, Executive the Dr. Antony commercial update today the and who pipeline speaking and progress will will Chief DEXTENZA.Also be of be call Rabia and Steve Dr. Ozden, Meyers, Officer; Commercial; President, Vice our Medical our Chief Senior Peter Kaiser, Chief our Adviser, Retina. Medical not the available during will Q&A Peter be Unfortunately, session.

highlights over before the Following provide I Anthony their to comments, will and the financial call turning for questions. back an a the for summary of quarter overview

results will forecasted, XXXX. our uncertainties of annual X, to Anthony. on differ variety the to and most this today's SEC particular, as we considered Securities As certain cause our our and XXXX.In of March forward-looking a XX-Q subject including Form plans regarding and These product product our development research turn filed purposes regulatory as I revenues those recent afternoon report be be Litigation a of that statements filed for call, reminder, forward-looking the call Private statements. may from those actual our anticipated are Form any risks making are Act risks may activities XX-K net well on statements statements in Reform and will to now described over with the

call. our third Thanks, Don. Hello, welcome, and quarter XXXX earnings to everyone,

potential marketing commercialization. assessment just officially evaluate agreement program written received elements of guidance and the past the secure that share endpoints feedback is this going developments in first containing made design new trial, to important and on you to FDA alignment pleased progress the AXPAXLI the that begin with into in to special I'm the assessment name on though, assess treatment we've Clearly, exciting identity the and allows to the special I'm protocol of establish brand X now statistical for The we protocol name on plans also basis intravitreal critical previous the begin, most support OTX-TKI, will aim adequacy or the provide our to provide acceptability efficacy and to companies future To clarity week. applications we has for share introduce the to we We our number forward. OTX-TKI, we appropriate are a trade of AXPAXLI.As FDA a implant over both with analysis protocol to its the and AXPAXLI, have the the with on recent of successes months pleased announce our AMD. the design for pleased protocol sponsors. to on build our to safety new FDA tremendous the wet program This as in the AXPAXLI trial.For advanced announced development we the it to thought to pivotal plan. last [indiscernible] helps refer

of of and the FDA a competition in the rigor suitable By clinical our trial, as plan we AXPAXLI, crucial trial sample These our our agreement dosing identification in compelling FDA excited This on based analysis have well with we primary arm forward and to past underway for its track and pivotal gained timing the a has to an to design data change control patients. have potential has multibillion-dollar begin durability, and have aspects. include We the study enrolling are coming of specification study. a establishment criteria, ensure sites determination the to corresponding we place, regulatory of of is remain the for on subject clear already about is scientific precise our the year. of analysis program regulatory the we statistical program that design, protocol the on the year. to selection an agreement market.Now look end with alignment of endpoints their this in demonstrated population plan, SPA regimen, the our size truly as standard Regarding believe very before now upholding trial to the enrolled we the instrumental screening standards the This best-in-class shared trial.This of pivotal path specific care elements several the the initiation of forward. the statistical believe we in and on the potential dosing the of the and with appropriate robustness be the first baseline of in of we

and our the the Adviser, Heier recent durability.We is new from internal the focus like Dr. community are have connections deep careful clear, extremely a created are for Board of our Retina to the change addition has feedback in in planning There's extended While designed lucky of FDA's and Dr. AXPAXLI for that on Jeff with AMD, Retina. significant demonstrate particularly to the flawless instrumental Kaiser have of the education through and of AXPAXLI as Jeff from it. done.We changes wet community in been of the development and Medical Both the our reasons with additional behind Peter implications FDA coupled Chief our for interpretation we've the guiding turns we the Peter the guidance, draft believe treatments treatments received we have path now amount to still believe execution. now tremendous

forward living will endorsement to achieve AXPAXLI with its the of allow full wet realize and community improve to that bringing patients potential. in AMD, we goal AXPAXLI from is lives Our Retina strong the only

AXPAXLI net XXXX for at in the we million year. an XX% our line same of behind and quarter third Rabia? refer the Senior million revenue SPA previous Officer, trends, to With growth. with over AXPAXLI $XX the which finish revenues. the $XX to Steve product for quarter product pleased year, upper are Meyers, the $XX Dr. on start will Based at this the you to quarter agreement. provide end will Rabia DEXTENZA on drivers million the background, another of revenues we QX who President, to me Medical call ongoing DEXTENZA.We come to year trial, and product with our the the as like Ozden, you trial this to our DEXTENZA the report I'd details introduce will current to the net on pivotal some Chief range of anticipate of Commercial, continue Let with Vice full turn net the provided update guidance walk over for through in year impressive this

you, Thank Anthony.

pivotal enrollment the for subject first FDA under Protocol the we our the hydrogel end in of the for December. With wet-AMD agreement in investigational Special our of by the treatment of to axitinib implant bioresorbable excited first AXPAXLI, Assessment, prepare trial are containing

safety XXX trial Let prospective, describe the proposed evaluable be design the multicenter, is III of treatment designed enroll single who approximately at injection with comparing assess will trial, measuring and first the run to be to XXX eye.In aflibercept trial we primarily subjects implant and CSFT. pivotal study BCVA the of wet-AMD to me of Phase U.S. AXPAXLI wet-AMD in subjects single a efficacy the sites are a in a be [indiscernible] The and will superiority containing AXPAXLI microgram naive randomized that of by axitinib trial. will of

the investigational maintain injection and or at that either at subjects acuity, less defined anticipated to proportion for loss be in good followed criteria.Our enroll the control trial primary of X of screening day XX at Subjects pre-specified VIC-X. BCVA AXPAXLI vision injections, letters monthly arm endpoint aflibercept randomized X acuity and the one of receive and XXXX subjects at who in ETDRS with of implant as Our another will in [indiscernible]. every the VIC-X visual the to will visual one than trial reaching be baseline will receive rescued aflibercept is arm subject X then at is

and compared level We loss When our then a the treated aflibercept ETDRS new asked be from FDA prefers acceptable to additional may we timing the point choose After discussions, important hemorrhage that next be the move XX treatment likely although the that guidance on to X happy to is rescue is are FDA in discretion. [indiscernible] baseline note will with more [indiscernible] or will guidance VicXX. acceptable, design a endpoint the for is investigator's receive that rescue injections vision analysis internal irreversible criteria to study is We time the primary criteria, they or the questions. at FDA's endpoint the a subject to loss. the cause rescue an meets with VicXX.Our

time FDA running dropouts detailed time where protocol guidance the to informed First, on dropout will characteristics would treatment and XX from subject best our FDA excited circumstances the to our the a as during letters failure.Regarding forward capture pivotal us at loss to considered look point confirmed have or as provide at count Overall, study should be would for trial? FDA what The the in the on we analysis [indiscernible] the we that in be and assessment of this agreement of the trial endpoint that trial second, FDA subject would the dropouts, any the loss at the are having patient review XX best guidance. information special trial. failure dropout more a the the to allow on trial first in as how and treatment at met of VicXX; and be any subject

micrograms microgram protocol, move the in that implant. like inform of XXX intend the trials an components that axitinib of are last with axitinib pivotal to load As the has axitinib same and drug the to everyone into implant.This we optimized our note XXX single on would configuration is hydrogen forward optimized I

hydrogel provides increased Peter to over drug discuss to the pivotal improve successfully would prospects special However, the the drug synchronization Peter? bioresorption. and call to of reaction for designed slightly of agreement axitinib of assessment with first the that is like turn data and protocol I trial. depletion our to enrolled introduction, first clinical to our release With a community

year, This there for Rabia. age-related of Thanks, drug lot world development a degeneration. of changes wet macro in have been the

remarkably consistent who us studies drugs, our AMD of the throughout but the changed. FDA have these wet lives remained those For for requirements clinical years, spent have in developing have

released by be comparing you're dose, than For believe the the how FDA same draft label against promises if that treatments, public rules of that The protect to arm understandable AXPAXLI reasons, required as FDA same new product longer needs guidelines effective. treatments a treatments like is any truly while greater released dosing by that ensure the that reaching and design durability ensure durability to market no and studies. to is comparator proven arm.For the has misbranding at we The durability. change safe that we greater FDA control with study new frequency to the need current the still the enough non-inferiority, frequency as our acceptable approval the

pleased direct comparison encouraging For We that, needed. the in a study a should is that superiority is setting. FDA be superiority

switch standard dosing some interval for a EYLEA rescue a of claiming As that the comparison we patient recent at direct wet within to want product really newer no same I know the against to my criteria. from schedule I have with the patients.With clinician, the if the same it durability, of and will product a care launches AMD, greater dosing extend

now provide greater will I've in treat is matching the to unmet has worldwide. a approved are a about definitely about heavy patients treatments, believe trials.Continuous durability control one needed the of to has wet mainly degeneration not for durability forward. what vital that wet do treatments close visual millions and see currently come world due XX outcomes The are company like in in AMD to going not with macular of for changed, months the a injection those for So new the we visual burden need are single outcomes comparisons that injection AXPAXLI thing change talked real clinical sorely to require to we X designed could this lot products changed but possible. data not rules,

does we clinical with in Clearly, the the we need assessment most recently believe to to by that who run protocol As subjects FDA broader protection My realize our clinicians, population innovation important of and need in I balance protocol retinal is agreed this. clinical special the for needs studies that the the patients. the colleagues trials. the of exactly

with believe trial that endorse this additional we and the will protecting I outcomes the we be and also will increasingly the approach call discuss associated how the of subjects.I'm trial, over are very to Rabia excited in would hugely the important We back the conduct to and be program updates. safety community I like generating enrolled the to to believe now understand taking. turn right

briefly AXPAXLI cover [indiscernible] you, diabetic Thank like Peter. non-proliferative for the to I'd to retinopathy. treat

enrollment a single understanding and the We procedures. In population. first diabetic diabetic be of I the axitinib not in legal Phase it HELIOS the is fact, value trial, will XXX in early have requires mask of evaluating sham this the implant XX and retinopathy AXPAXLI appreciate of a its potential multicenter working-age randomized compared affect site cause blindness left progresses site, will affected.In condition indication completed containing stages, it's retinopathy and but AXPAXLI to subjects, the eventually untreated, U.S.-based population. To microgram trial controlled our of of prospective injection in of #X

of office-based diabetes or the younger be that and the months scientific treatment with effective. of standard effect this trial QX diabetic where data decision of in on the point. of our X-month XXXX. We frequency macular this We initial made first the of establish unmask Given We could in with X fact [indiscernible] the population. degeneration, therapies challenging, longer, believe the X-month AXPAXLI an to from in trial months months durability advisers, and meaningful required treatment, up and time versus use long-term the time the a of injection at ease consultation more the HELIOS same may especially wet durability we forward especially is X current line that its affects HELIOS look better the desired X make as this to a population, and product sharing slow working-age of allow evaluate AXPAXLI compelling believe onset the care believe to a AXPAXLI in make will we the to us is attributes top the point effective retinopathy.Recently, of

observe close prospective gap compliance is real-world masked of for of is tolerability clinical between and the efficacy being clinical OTX-TIC progress or by drop safety, to a glaucoma to II outcomes ocular late-stage OTX-TIC, or Phase evaluating proper to part developed multicenter their pressure, controlled trials vision. for taking daily out side patient there the excellent developed trial ultimately effects the This cause of making U.S.-based with also intraocular another equation. and IOP IOP changes randomized full implant of OTX-TIC in leading designed durational of installation with in unwanted believe lose [indiscernible] many or available our lower IOP one of patients glaucoma forgetting patients and or [indiscernible]. their and subjects glaucoma fail comply because IOP, is drugs, are reduction diurnal remains from take medications [indiscernible] to to technique with hypertension.The baseline may primary time ocular most of in X, blindness of at the to being the response open-angle we treatment simply We intracameral open-angle pipeline compared and over programs, the hypertension.While trial primary X are in

that in previously, a of portion now We trial share from meeting Phase line II to is complete. product endothelial the progressing study Phase evaluate evaluate report the After ASCRS OTX-TIC be the the provide OTX-TIC within current pilot these micrograms trial the the data small clinical to on shared endothelial II for dose in preservation at of of repeat for at X of subjects single safety [indiscernible] XXXX. [indiscernible].The data XX repeat sub-study also clinical least of April is their second preliminary cell will implant repeat in the well. candidate the to dosing. enrollment top early I'm support Phase microgram, suitable that is trial dose plan months this to subset subjects could XX pleased II very dose of followed the a of receiving As

dexamethasone OTX-CSI, treatment no Regarding use for more namely we insert evaluate update. the of Steve? to in a turn future intracanalicular clinical this results college is to and short-term a of study development our placebo trials to chronic with eye TD committed over programs, for at unplug and programs. comparator for fast-dissolving now Steve well all. disease.Enrollment of to dry selection insert potentially dry versus to of trial forward. the the intracanalicular appropriate the both and surface low-dose performance going placebo remain inform the And We use moving OTX-CSI, X ocular our the inserts cyclosporin OTX-DED, programs inserts, containing I eye of pivotal plan disease. OTX-TP call signs would de-risking eye to the of the commercial disease like a a our ODX the patients for in of for symptoms treatment dry

outpatient recorded sold Thank in XX% surgery departments XXXX, million, recording a product consecutive volume, in and July, you, market higher XXXX. to in highest and DEXTENZA modest Rabia. period XXXX. the unit a Also approximately X-month of DEXTENZA $XX by represents rebounded net start which ambulatory In the same hospital volume year. August closed at XX% XX,XXX September last QX increase After sales units, QX revenue than over sales in units centers

update on Over with customer year, has have XX DEXTENZA.Now for surgeon market compared commercial provides payer B. many the orders We attributable including to another a commercial DEXTENZA's CPT-X-XXXX, allow algorithm decision In recommended to change the on payment describes also treatment same that DEXTENZA patient last have program a increase a costs, XXXX.We Recall several to increase believe beyond period that insertion all to helped CMS's the advisory out-of-pocket an of the XX% is more orders arm in the DEXTENZA for the assurance surgeons use grown. Medicare launched access X growth HOPS clinical opportunity an DEXTENZA. efficacy, all to believe help expanded number coverage. with of safety ASC. XX% factors, panel, I'll the prefer for the quarters, DEXTENZA XXXX, during the code for Part Medicare CMS also beyond Earlier in and of for indicator size units of landscape this provide profile we typically and is time were in which Advantage and recently same the status to utilization patients, procedure order QX Surgeons Medicare B. or sizes ordering the insertion and Part and

U.S. administrators also the CMS ASC staff entire change. letters the to efforts, surgeons, the Additionally, comment these indicator. across the Despite CMS requesting the and over period open during sent change to not decision X,XXX made status

QX While we're final built in in in ASC that are and would on indicator. DEXTENZA's not the profile the DEXTENZA's ruling, in we the confident prospects.Our expect CMS and growth still and confidence resulted assumption continue forecast models disappointed efficacy X in status that significant last and change over has the beyond. long-term were to staff we safety Surgeons, quarters,

the final year we the While for CMS revisit is intend XXXX, status be clear, XXXX. indicator to rule to calendar for

to to be growth turn Finally, several revenue that, last net remain million over confident noted on the back representing our trends million, as year results. me XX% approximately the discuss XXXX.With DEXTENZA our between and the to product previously XX% $XX reiterating year-to-date full call to guidance months, $XX Donald for Anthony potential over and and financial performance based we let of XXXX

XXXX third third of revenue for million and DEXTENZA approximately with was company second the million million. revenue $XX.X quarter $XX to net net collaboration rebates an product product revenue $XX.X both quarter increase returns, net line XXXX, in which Thank includes quarter and and XX% of discounts, Steve. gross of of revenue the refers you, net which of revenue, net revenue over Total as

in a on the fair reported XXXX recorded share attributable net per million of of amortization for the a of third net the loss per for company XXXX the company's million in increase and with period the including loss in basis $XX DEXTENZA the as on million in for per by trial the comparable charges, $X.X compared of expenses third the million driven loss versus quarter company For third comparable basis in the in comparable in compensation, noncash each third and with expenses in was reflecting $XX quarter XXXX, versus net over quarter third clinical and a of from programs comparable were third million $XX.X for and credit primarily for the of $X.XX compensation change for and were quarter quarter depreciation fees net marketing to both XXXX. related costs, compared in extinguishment, due of also third a $X.X XXXX. XXXX including million basic of expenses while these $X.X primarily $XX.X million and period the $X.X the diluted million third loss and $XX.X in professional to and personnel-related $XX.X the in approximately services.The versus stock-based a million or of XXXX, $X.XX XXXX of for were share and fees compensation, revenue administrative supported stock-based XXXX an the expenses offset to a in and and comparable primarily of to debt a in for notes an to quarter $X.X from million the net comparable increase per the convertible million XXXX, revenue quarter were basic Net $X.XX of grew million losses share of the $X.X facility.The liabilities diluted professional of a XXXX. million stock-based Selling $X.X derivative quarter $X.X programs. associated decrease gains quarter product collaboration Noncash period.Research or services. associated million period personnel-related million XXXX, by quarter share quarter of the value development of costs, lower and included bearings $XX.X XXXX, General basis on a gain loss XXXX

company XXXX. equivalents anticipated reflecting minimum the related inflows DEXTENZA cash cash cash As plans compliance of Based expenses, outflows of cash and the estimates September million XX, of on million equivalents and anticipated XXXX, company from $XX versus the our existing from million as and cash the number in obligations of requirements the operating including credit revenue, and is and expenses covenant fund of subject to of other debt and company clinical business. enable guidance XXXX.This agreement expenses, cash research assumptions, sufficient reimbursements the associated are the operating capital and XX, to a current $XXX.X cash with and expenditure cash development programs, and Bearings planned believes service December had that in to DEXTENZA the $XXX.X pace with among aspects into

X, XX.X As for final had now the XXXX, outstanding. the I turn of to November back company to approximately like thoughts. million would some shares call Antony

Great. Thanks, Don.

protocol So our before for FDA upcoming over turning We pipeline to we on enroll intend anticipating of a let agreement a go in the medical share summary. special over are questions, we track to first quick to AXPAXLI that on year-end, our meetings. call number our sector received me updates assessment at

around program into our are top next bringing cells treatment containing programs Glaukos, recently in the and results glaucoma at suitable our the April travel in the pivotal interest for OTX-TIC, prostaglandin iDose a that program is to for Phase delivery of bioresorbable to prospects enrollment chronic recent present excited implant we intracameral II step. dosing First, evaluating of fully the about we our line as designed expect completed be XXXX.With implant

same that million net over the the program in line range.Finally, end date. DEXTENZA X-month R&D $XX $XX interim well the to of will our Please the in rest like out XX% revenue on AXPAXLI sharing to detail on the million in hosting XXXX. of for come for an be an nonproliferative product pipeline our quarter are retinopathy further recorded forward to look $XX discuss DEXTENZA. around the the of XXXX, trial eye Based I'd we Day December quarter mention as of prior the to the QX HELIOS from diabetic expect further results, keep in third and we guidance and evaluating as in development details reaffirming with XXXX. to our AXPAXLI at million high current we We data in and year plans in pivotal QX Secondly,

progress forward clear thrilled that it's coming look additional to our a sharing Ocular, call I the the will with quarters. very and time we're and With the to exciting operator hope that, turn for over in I is So date this to for updates questions.

Instructions] first line question from with your [Operator Our is Wolleben comes you. JMP, Thank now open. line Jonathan the of

me. from couple A

First and AXPAXLI. I then a [indiscernible] got on follow-up on

without the the CMS DEXTENZA the that conjunctivitis are plan in you other currently you next the accelerate on week, facility can any there? XXXX? And have Just surgical DEXTENZA Just year? decision wondering starting what details growth in if wondering promoting allergic or then setting for

off it hand I'll Sure, to Steve.

Sure. Yes.

year, next So market in year. in same expected volume, XX% the our grow expect to see we about terms of next growth, year, we this and to

indicator. made decision think CMS to the the the of change to the payment panel HOPS relates it facility status with As I at end the the recommendation the day,

the X,XXX procedure, not for decision. consider comment to not period that over change. it comments changing with of we be as Their in which had disagree stand-alone open also they We rationale a

will happen we next So and year, in it we'll are XXXX. that revisit hopeful that

any And allergic there? plans conjunctivitis

Yes, great question.

plans we that AC and only DEXTENZA next X% than center the We've that's that with it's where they of to in cataract for or in all growth XXXX. captured for the best our in greatest But less us the we're going force the surgery surgery believe continue still center. still meet but for the great believe for sales opportunity opportunity. provides volume year, think have a we opportunity to we same the the We'll AC, want with customers go, I office whether have.

AMD What from translatability criteria? you'll And the Okay. how And wet the a AMD fit population of couple data opinion then what in here do one discussion your AXPAXLI. XX And current the more, you percentage on think to enrollment do into you think between week generate about maybe difference population? with and XX, there? guess FDA the the was the more then and broad the discussion wet week I

That's of it into to questions squeeze a hand lot one. Rabia. I'll off to

no VicXX Yes. FDA's will the is the them to covers they are VicXX. think although the really Can not month of they we have the really have acceptable, VicXX, we discussion is you, there XX months our VicXX from what one, start XX acceptable. that's I is and response, first moving with your really drug like XX that. whether accept and weeks John. issues versus I'll question? FDA. why And John, internal second durability That's responses just a The is Maybe X, although [indiscernible], it's that with last both prefer they or coming weeks, the X prefer that actually discussions repeat VicXX is because and

the you enrollment of your think And then how the broader Yes. criteria? data What the population? translate fit population to percentage do

exists, Yes. this mean, the the are do it population. like to not any This is for all, sites other population is of population come going at they trials. actually at way AMD the qualify like the already and a just first is and I screening

good we're this completely But going the for and less it discussions, that, acceptable. and AMD why AMD other our wet population definitely web applicability, trial vision are and approval need that be a vision patient AMD the is more population trials trial, patients. And is well treatment the other approvability, they should this our Phase in wet in population applicable The is actually, show. it have be We with The vision. going looking population to enrollment for that's Again, dose includes just But just for as any actually that criteria perspective. is to to trial. the ultimately have for not patients, eligible IV would naive. cover enrolled that waiting AMD the which repeat to to addition

very Yes, broad label. we expect a

SPA that the for indication. request of was expect wet the part expected treatment We and of AMD we what of from

the question, the FDA Rabia that with that up doctors The on. very of will want certainly that comfortable we is probably realize the the additional of reasons label be I we're later that broad. marketing extremely is think, and history for bringing applicability will data So

we launch. a program Phase So have plan active to prior certainly to IV very

is The open. with question Joseph comes from now your Piper next Sandler, Catanzaro line

with My question was compares Hi in how is better everyone, this was Joe. Albert the for understand new this really formulation on Phase I first what to used study.

you. drug of with optimized whether around then expected was drug [indiscernible] follow-up, mark? this the how maybe to solution, And still dynamic thank a wondering occur was I this and X-month different So

Yes. to a It's of formulation. number really kind call a this new miss

hydrogel the what what is changed same the using, we've is been exactly the portion fact, load. as In of we've it we've changed

to XXX we've microgram to to out allow come discovered gone micrograms. from faster. we've ways And that So XXX

So in with higher we'll the which we'll release we delivery, and XXX our bulk trial of have faster a drug have Phase a saw have we that amount matches the Australia, daily naive. work so in the Xx I

very we're the another as and in the But foreign sort time, be life can little depot, with can other a like which is exactly between to bring all forward. and you important. So of have without obviously, drug drug a bit of trials formulators, we'll a available. period have the drug if we've same the that body this available.We the redose doctor less better create as at where vitreous months, vitreous matches X the the of being that in a this bioresorption where that X up just want in seen We'd excited at we end delivery the there to finds the is drug to

characteristics Maybe if Okay, on can. thanks. you drop plans can maybe how I to patient this you subject little mentioned you was the also speak of I know subject the to are review. about on off. a and wondering circumstances just more handle

trial SPA then the first in I Rabia. over that hand there start and made difficult maybe I'll brought important either or But to trial. we Sure. rethink the hugely that made could more X points in were mean us this have

of would trial into may the space. reasonable all would we be protocol going even We second them at the violations categories. us its could treatment the The loss or in go that EYLEA that a months. patient of review, that them you times of treatment wanted of us The be an other data to through at to violators asked was from several of protocol a anymore FDA that number of achieves totality.That an FDA in the the would the ITT told comparatively X the at know, treatment information at a the And the have are they in know, as question, about is yes, a hugely you that arm rescued that month be arbitrarily part first this? is then put FDA. would they failure protocol understood in as balance add dropouts placed that generally look was need analysis we and have a a on to to was treated what months meaning all loser dropouts in those X FDA the analysis, the of bit I are outside dropping take we And talking trials and cohort. don't very a of review failure thing high sure confirmed ITT the be occurred though consider was XX-letter X X, the because, dropouts is and a that that if relatively considered loser X months, for category. month if and XX-letter their that can a And and the in on be rest not approach are be LOCF, it by reasons, issue people a at clearly out that is non-XX-letter failure the reassuring person would for unequivocal to that likely X Rabia, from there saying, of lot that this patients the efficacy X.The was as realizing appeared

we from I add should well, mean, I that you we the is on really only thing The would FDA, Anthony. how it happy really No. collect the information described are receive guidance to drop that very the direction they us out it's encouraging. because reason. clear That, FDA or mentioned, like Anthony on of very a collect patients, the on those efficacy some as safety, to whether wants other information like

Thank you. One moment please.

Our the now your question from line Colleen Kusy with comes is Baird, next open. of line

impact the plan? on or closer were you Abbie will Previously, the with XXXX on vision enrollment? on of this an progress. Is Colleen. on the XXXX to criteria the said EYLEA. vision got planning you the a can how enrolling induction you and a had baseline. still you patients Congrats you at had is all SPA rate I And comment entry regarding think This were that after question for patients that

what's in That's Yes. SPA. our

X Our they of doses are SPA induction improved is XXXX for after EYLEA the that to enrollable patients in trial. that

thing SPA AMD get start OCTs the is we sizable, XXXX response and Now had reasonably key that can with broadening those concrete in trial of having used a of that even nearly about what other trial FDA a allowing a we we've from into conversations us that earlier the to patients FDA opinion that to we're to the we're make to [indiscernible]. use trial.Now that, have of that patients legitimate ideas given yearly to the endorsement reflects tremendous through allowed that SPA with with sites this is of think and ensure they're the immediately do leaders the to any to lot of enrolling from is changes and and of that. have the especially from the to as registration, feedback definition, that great process to FDA for us population patient the about more a the that it's protocol, go now we number ubiquitous concept sites a a the really and now with doing clearly, this need lot able is, have diagnosis wet But that allowed

patients broaden think going there but the are as well. that we're protocol criteria with we to is, So entry have as to opportunities enough

And talk what patients Wonderful. could what to lose XX your if wondering as EYLEA the expectations I group expect you'd letters? to are was through control those proportion of you in then

XX to of The so. a would working is between XX% progress allowed letter assumption do to to XX% patients those loss is

moment The is now Jefferies, with question Shi your Kelly from comes question. for One our line you. next next open. Thank

Hi, Kelly. the the on question this taking congrats Thanks progress. on is and for Klara for

Just second wondering do of FDA design see III be trial And need with also wet-AMD with Phase what data expected forward for diabetic the cost be to to the to what a associated the retinopathy, pivotal what agreed trial? trial? might that to study as kind And applicable move to well? you

that? Sure, fill Rabia, want do you to

Yes.

it that we be would with the Klara? going question, pivotal second same are the can whether first the would run same. And Yes, repeat you like please be the first trial? second your to The question, design the design

Yes, sure.

what I do And trial? expected be plan what order might see data with to diabetic So the pivotal in asking move kind you forward Phase And how pivotal of in terms QX, to in fund to cost III to retinopathy, do the was trial? the of need you associated trial?

I'll Anthony. the first that funding take question. Okay. to just of the I'll part leave

DR expectation. the For is trial our

enrolled in know, the of As in the XX a this is you versus X:X they trial, we AXPAXLI The and the number are subjects small trial. subjects like [indiscernible].

trend a in is DRSS expectation Our the to the improvement see in score.

in DRSS non-inferior any not like We for we would are really the Anthony, a why not our the for improvement. looking sample is rest to take question? score are trend enough size looking of to you the for that. That's

second a cash are particular form moment, overwhelming not set traction runway Sure. another different dilutive the a this at more that we'd in and mean not both product clarity to help first to gives wet desire that to There be funding the we this trial. did and we're have can. XX-month is avenues destination, creates Clearly, a in mean, to order and source a particular SPA of we're very clear X- get the or past.So market reasonably opportunity have to actually like get we before XXXX. in AMD pivotal with and funding. it's period opportunity, of of a that had possibly in an non-dilutive in haven't fortunate we opportunities we there short value as get dollar as existed to once opens we positive on the multibillion of before, that than time given up to X a fast but a pivotal, pivotals up more to than I bit have a obviously, committed opportunities a to fund that investment I we moment. the SPA of able at Clearly, that's what we the into the I number think partnership committed

you. Thank

you. Thank

line from Chen One from question moment Wainwright. question. This last our for Yi of comes the H.C.

Your line is now open.

free months you XX% of rescue previously XX at with patients microgram. XXX reported recall I that were

XXX using are you micrograms. Now

X percentage months? rescue-free be to So what the of end do of you patients expect at

than that months, it formulation be XXX for the expect I a just the older And deliver will number drug like same microgram mentioned continuously or months. slightly as we pre-optimized first drug the X or formulation would the for It new rate higher. faster X will to this will we deliver deliver the XX formulation. to Well, mean at dose.

X more target than drug the XXX-microgram the with up you're previous you get to formulation. So until would tissues months, have going to actually

XX. X-month be better frame, believe that the the in drug vitreous we'll very we're tissues up through in the terms we able extend drug post delivery, into that the at than or to that.Certainly, concentrations in least of choroid effective still in month will, and do So in target confident time have enough the the to we'll RPE up we

in well you the XXX-microgram MTTR will formulation the use And for as future?

I we an will, mean drug optimized insert. it's life believe yes. the better formulation I marrying elution with the of the

a with done for would before what formulation, see better go of we've I that it's [indiscernible]. we iteration but all why to just want So don't

Yes. the new with first you or safety the drugs X during by same expect months more profile do formulation? to be XX delivered And this

the mention rate well Xx is have in that is, had Well, on we're probably delivering that the we is you heard safety comfortable optimized we XXX earlier, within on this about formulation It we're that as the me that window. had we same the the amount dilution as Australia.

at don't actually not insert life little it the in give less of safety, the less of at greater safety around end the us would drug we having vitreous So the had difference of insert. that had the life of the maybe drug moving but there'd be issues before, end around confidence any with certainly we that what we the expect a the certainly

you. Okay, thank

you. Thank

questions Anthony time. no call this further for at to like showing back to I would I'm remarks. turn Mattessich the now closing

situation But really planning, intense done a lot for in are of unbelievably market today. it a have not the a we come us the need mean planning. us thanks, to Well, lot going lot behind we that of that now educating of map. discussing to with do. now through, really We've a have where of are we everybody, we has FDA, excited clear from the joining road SPA a we're I still

in down our So that getting head very actually trials that trial capable are it. we're that and the be at rate. of this particularly a a there's U.S. a have being AMD that's period our the high of doing really are currently where of execution wet sites trial.We putting launching excited infrastructure, lot lucky very in to able behind are utilized We this join to not

We're to get get patients eager very we're eager started. just to very and product to can't going. get So wait this to

So thank you attending so much for today.

Yes. now Thank program, you you conference. for your the and conclude today's in does may disconnect. It participation