ALDX - Earnings call transcript Q2 2022 | Aldeyra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Aldeyra Therapeutics Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. I would now like to hand over the conference to the company's Interim Chief Financial Officer, Mr. Bruce Greenberg. sir. ahead, go Please,

Bruce Greenberg

quarter of With Chief is we copy Executive reporting press for statements press everyone. morning's this recent performance XXXX, our available highlights. corporate issued Todd President release the results the conference financial contains and Officer. our forward-looking release A June me future morning, XX, Dr. and today Brady, a ended Good on Media events & future This that Investor of Please our of note the regarding and section website is the Aldeyra. at www.aldera.com. call morning

include, our not future future potential position operations, and submission commercialization, statements possible are trials our trials of and different may predict portions from These of and clinical analysis to, uncertainties, accurately of future control applications, of They assumed quality available clinical results opportunities. timing anticipated clinical or growth upon statements trials, candidates concerning that financial today to of results and based from Aldeyra's are systems-based Forward-looking expectations or results regarding approaches. but are including the us potential to views for our Aldeyra's events. and for result risks subject drug regulatory the runway, plans development, The potential and and or trials same cash new statements clinical review the current the risks not indications continuing limited assumptions expenses and and clinical on product based reflect our information of projected or data.

COVID-XX in circumstances change. the results current position. the may delayed. future as results and and obligation those update have Future potential and patient site clinical differ forward-looking complete impact Aldeyra projected assumes could availability, our of been on statements trials of As and actual operations pandemic our financial be including from a statements, result pandemic, to COVID-XX these negatively and affected lines of our the recruitment no to time the business, materially events staffing

from Additional information our statements to concerning and factors are described the that will could over press materially Dr. SEC. greater in this our in Brady. the cause in release turn issued call now morning to our forward-looking differ with filings I results detail

Todd Brady

you, morning, on XXXX, far stand a everyone. good Bruce, Thank accomplishments out and so reflecting of me. our In couple in to things

diseases the on submission package suboptimally has We're surface weeks The lead what advancing what team of excited of investigational administration rapid today disease amassed first ever improvement. a believe the regulatory drug second ocular We've paradigm potential the in is and to what unparalleled half to our made a world's that reproxalap the application primarily even at comprehensive is of addressed most our dry action. for candidate be for of prevalent to progress with in exceptional XXXX. new drugs most onset planned change new treatment reproxalap's in one an eye modest about the is believe is require we drug we which least based drug

to Phase dry a or the achievement the improvement, and thorough and believe three trials, III redness, analysis. XX-millimeter the in TRANQUILITY-X Schirmer we sign of recent the to With crossover responder than endpoints objective put symptomatic test disease; and test submit NDA completion extensive ourselves position robust on of of equal Schirmer ocular we based and a eye greater

dryness, symptoms, on outcome trial is of reproxalap, the the which production the stated, and of burning crossover tear observed improvement ocular redness based stinging. activity the As including affirmation rapid I the previously within of of results onset potential key included and minutes of discomfort, trial in

p-value of reproxalap on endpoint day of X, for was dry the with ocular in for and chamber eye and day primary one the X.XXXX Schirmer a the redness redness superiority For of Schirmer on test statistically X.XXXX ocular test. significant

I and profile. strength safety of think trial reproxalap's crossover is our the takeaway important from tolerability results other the

now Our consistent of one signals prior has reproxalap administered Consistent most than case installation more lasted patients. any is clinical with irritation been with well-tolerated experience no in minute and with our common with event in X,XXX patient. most trials in drugs transient has and encompasses all The topically adverse site duration. ophthalmic observed generally the safety reproxalap drug less mild which

evaluate reiterating disease crossover trial. I in eye that adequate Aldeyra drug also and first the to to worth our it's think knowledge, investigational is sponsor well-controlled dry

is conjunctivitis relates observed demonstrated the on successful only it completion The patient-to-patient design. As also rapid of our disease trials. therapies but that other trials potentially surface and high of II be III disease, that we is release also that trial for I And as Phase noted ocular with effectiveness with crossover data degree crossover dry trial to not design involving reduced crossover believe eye reproxalap's we've design the from can allergic variability the the activity. has INVIGORATE feasible the learning crossover key Phase call, a for

a In addition, Phase INVIGORATE-X trial trials. III the crossover ongoing is

we NDA half following B pre-NDA Type year submit US in eye Administration and our Drug with Food meeting dry our this quarter. the disease expect ahead, of Looking to later the second in the

is genetic is group or is with are FDA we site-threatening on lymphoma, Aldeyra. each of of the the PVR number failure represents drug investigational year. proliferative development and schedule vitreoretinal out fluid therapy. such potential vitreoretinopathy for for a conditions. first unique three, three of Results to a of for of and a of from stands indications The with half opportunity retinitis diseases fatal this The ADX-XXXX has progress the platform GUARD PVR to be are the orphan be one, and reattachment but the condition The surgery; believe ADX-XXXX these program formulation therefore, other X of in designed granted Phase retinal expected which encompasses drug ADX-XXXX two, a and which diseases. eye, rare, to our cancer; the accomplishment retinal trial that new and pigmentosa, specifically universally that a cause serious Number approved humor methotrexate no designation is commercial eye rare ADX-XXXX, leading primary vitreous the our what back of near second for compatible is

multi-center over GUARD trial a adaptive repeated a As intravitreal to primary is the Phase discuss period forward we primary for controlled half endpoint in X the of XX have reminder, lymphoma, FDA to injections clinical weeks. randomized a path meeting the of vitreoretinal with Relative detachment ADX-XXXX this to of of The PVR. prevention is the year retinal a second regulatory plan for pre-NDA in XXXX third the from of enrolled the Eight trial Phase with the we injections, monthly a reported three are top line pigmentosa, other the XXXX. for trial anticipate expected which first over and patients half receiving is twice be months. intravitreal injections in the the ADX-XXXX. half to And period finally, results half of in receiving X monthly be key retinitis intravitreal milestone to of

pre-NDA regulatory anterior in both ahead the results Lastly, path pharmaceuticals. believe by be in real led you and one to meetings to and ADX-XXX Phase ocular are candidates opportunity on in market, advance broad two in X diseases, hepatitis clear ocular we our strategic a positively a trial represents pipeline in market plan syndrome report trials rare oral continues patient expect the minimal represents markets and platform planned I'd and Phase aggregate calendar summary in of initiate of NDA with Sjögren-Larsson balance submissions. in late-stage anticipated expansion in change from both retinal clinical XXXX. trial featuring are Phase of Aldeyra full cough the the of X results represents of two what systemic which to two from our first busy year with acute of chronic and know to a our ADX-XXX modulator in programs Top affect quite X in RASP largest we as inflammatory of steam mass line care This and inflammatory to for many to to a half And a top line remarkable diseases. disease, say, that and disease alcoholic we disease. XXXX rare

Now review. let to call me Bruce Bruce? call for over turn the back -- the financial

Bruce Greenberg

marketable research compared Based we June if expenses operating believe cash for drug on XXXX. and $X.X through existing current from potential programs, months months the $XX.X plan, immune-mediated the operating initial of million million cash, million operating development marketable preclinical securities increase of the and or and total per in from the with expenses XXXX. June Cash, of projected securities were and Research systemic million the product XXXX approved and in $XX.X ended of expenses share $X.XX XX external manufacturing XXXX was XXXX. million. $XX.X net and same and XXXX. upon general ended well Aldeyra's XX, administrative submissions loss ADX-XXXX, with for trials development $XX.X of XX, XX, resulted and costs equivalents for ended compared in clinical treatments in General the operating comparable of the that a million with including June June Todd. The our were period $X.X XXXX XXXX, $XX.X commercialization to XXXX and cash as expenses per with period will $X.X currently same have June for and three three for in product $XX.X diseases. million as million the sufficient million and Losses development share for increases expenditures. expenses XXXX reproxalap period candidates continued compared three $XXX.X were for for Net equivalents end compared expenses. Thanks be loss $X.XX million related were clinical period administrative of and cost XX, same of ended as ocular or Total the development in is of primarily the months NDA

back Brady Now let to call turn the for remarks. closing me Dr.

Todd Brady

Biotechnology meetings I that a medical and including; of a audience over the the in planned Citibank West Meeting which Cornia in the Annual Bruce. you, of includes the of XXnd Wainwright Biannual San Vegas, Conference American Optometry Academy Expo Meeting Ophthalmology Ophthalmology additionally, have Boston fall Academy Virtual we the next want be series in calendar in Annual Conference, exhibiting Annual the in Diego. Las American full weeks Vision BTIG the in Relations the several Biopharma we'll to know the Investor And let Conference, Conference. Thank Chicago,

As questions. per with like stakeholders a prospective welcome opportunity Operator a meet is and open get meeting. you current comments schedule invite Relations we'd now time to the to particularly my call for our to the to Investor know prepared and Aldeyra we team now to to interesting and today contact

Operator

from Catherine. question ahead, Please comes [Operator Novack Instructions] The Catherine go Jones Research. first from

Catherine Novack

if curious taking in for point? question. I'm much Has the this about the I you study. programs to talk sense would initiated? clearly bit and you wanted defined so about little can toxicity been a go-forward signal thanks a what for indication that a how And of Hi, my path be XXX-ethanol at registrational can a this talk give non-reproxalap the second.

Todd Brady

morning. Catherine, that. good on us thrilled morning. Thank for do a I'm you joining to Friday

are three. ADX-XXXX and in like your question. of buckets main platform think forget the drug you which which on headlined is that is systemic which focus when our buckets: think I Aldeyra ADX-XXX, feel I reproxalap investors RASP and there probably by mentioned one, often and reproxalap, two bucket about three is you

really potential thrilled think term three about for If long I those programs. I'm your So, question. with value

and exists my and of is As that this sons morning, ADX-XXX. daughters is I prepared subject that the remarks mentioned of disease ADX-XXX and the pharmaceuticals of one markets largest systemic inflammatory in in

a as platform RASP. on you have, is unparalleled. robust We drug focused platform that discovery know, think We

ethanol a trials is we're or And is the running what of hepatitis important crossover this calling toxicity. acute we're One trial. most alcoholic

It's morning were trials us You many fans were trials are ahead that in like time. on idea a and while and heard those Acetaldehyde primary for ethanol as alcoholics what forth. my obvious about comments crossover received or to causes of we what where weekends, how alcoholics. causes RASP, XXX It's cancer ADX-XXX what nonalcoholics. is of reasons, acetaldehyde. flushing exposed this of The really in causes acute metabolite known college patients ethanol, the were challenge, hangovers placebo big subjects which see, is is interacts either with so of to and in

at ethanol which variety activity much as exposure. trials. really is to RASP, is the a that to ADX-XXX. function acetaldehyde, include of looking of signal idea a your Symptoms cetera, with acute of tests ethanol So sort of rapidly after from some hangover of nausea, bad known discern with lightheadedness, to et would due liver including typical signs. The really symptoms elevated are these symptoms, objective We're in binds course, and biomarkers, of sort intoxication. indicators addition And associated

two to trial, where endpoint of discern which us to admitted if challenge trial, acute there a we're type more a would One to this patients the going is time acute ethanol signals is from trial, something for like to emergency think, are forward. due ethanol, be one or an able I exposure sort room an and the discharge. are options hospital

the to heretofore The is involved trial, us classic mortality. XX-day much other those are option treatment which the patients. available has a and alcoholic chronic period outcome is Obviously, sicker hepatitis

trial. the in to beauties those think, options we're good and a is, I particular are the of first ADX-XXX So that and even hepatitis one different we results inflammation alcoholic assuming challenge this of have prepared from variety systemic and options, ethanol of pursue

Catherine Novack

continuing with non-reproxalap helpful. questions. That's it. Got the And

FDA's outperforming NDA you to trials? be And the feedback additional post-marketing should XXXX NDA? on clinical might you PVRL, For submit anticipate able what clarify requirements with can submission the in you

Todd Brady

lymphoma the that for ocular that In The to ADX-XXXX which is that The NDA methotrexate trials ingredient particularly has been active program lymphoma. used sure. For are required has as decades the reason in us for treat intravitreal for least FDA is submission in is an in XXX of clinical injection lymphoma. told ocular at ocular years, not interesting. that writing

is stability on particular amount amount data What the available data wants there is preparation see tremendous which a efficacy FDA ADX-XXXX, methotrexate. safety the would the appropriate of a basis NDA literature, an of rightly for which So to form the submission. of is and in

As of that. injecting you into I XXX form methotrexate. are with only is vitreous Today, remarks, eye. compatible my which aware numerous formulation methotrexate methotrexate, the the in prepared we're principally involves mentioned compound of challenges the that There can and intravenous taking

wrong, used. injection all, must First the be concentration a of is high-volume

capacity have confined As unlimited you know, a and the is high-volume for not space eyeball Catherine injections. does

the always there's infection. Secondly, for risk

I ph, And the a preparation the what GMP be, in the the vitreous. of ADX-XXXX So the are and methotrexate. the time think interested to designed agency so same is exactly and is of at physicians while mimicking tonicity, forth that density

Catherine Novack

do then to about on some for you that? And is can your be and commercial seeking what on it. it for your on just touch talk a strategy reproxalap, preparations to Got color own helpful partner commercialization would plans get or to

Todd Brady

of sure pretty after commercialize analysts great from to no Obviously, question Another questions we're are other Yes. Catherine. more I'm reproxalap. committed questions and there the this series

think there commercialization. three small any options just One I are for company not Aldeyra. the is to partner

thus The pipelines I as patients has do small companies think the easier I Obviously of to has drug, the partnering is the is other to that is primary It for how partnering for so easy the to acquire do it most forth. process contracting it preferred. and with think Aldeyra It preferred. with and does size to companies with leverage, really that their but have not drug of of only with physicians, have reason because with for larger because the do not co-pays to does companies payers. cost of these for days do with patients. not

eye strategic dry compound exclusivity I interested and due say of either drugs to broadly drug And topical think significant not news number in I the ocular is that segment have there yet marketed losing other would or companies eye our or are anterior dry partnering, there eye of previously. dry is eye, interest. good and and to the asset dry genericization late-stage knowledge disease have Regarding there a interest a that no available. NDA-stage the a novel, for are And in large is the cyclosporine are thus, space

option decide is, staff. to launch, number launch efforts second ophthalmic three have own, group. a operations with news is, ahead Should There's to with prepared generally, our and internally. limited over that be four pull launches off. we months performed and good pull prescribers accessible well marketing prescribers. The sales are space of such and easy Those there sales marketing the limited commercial to the a to The number launch we'll easy off in of on relatively to of are a or years,

a The to the first relates least prepared a organization, at offload in companies. to used some external options, as group small with paid those overall, cost, of would revenues we that which optionality. third of is of partnering be back I or the forward. handles which that via have will front hybrid an back the sales gets different what examples office two biotech it sales there's We're called to move a of industry is and say, option, variety involves office contract generally that efforts. often And and companies,

As I puts think forward. to And Bruce that in move us a today, said all we're position. financed in good very all,

Catherine Novack

so Thanks much. it. Got

Todd Brady

Thank you, Catherine

Operator

Nochomovitz comes Yigal from The Citigroup. ahead. from next Please question go

Yigal Nochomovitz

Hi, And much guys just On characterized get your and needed question, very regarding of curious answers questions? well. the you you much And meeting agency pre-NDA for as guide purely Thank you've so, this the dry from strategy? to is how filing dry Hope of if Todd in what much are administrative, meeting meeting outstanding Thanks. past? those How team. this is to eyes. are actually to doing eye the outstanding I'm

Todd Brady

you, That of meeting that mind imminent. Obviously, for top question Yigal. us. is is Yes. Thank

waste B is interesting to submission discuss If pre-NDA think you -- meeting questions opportunity but format, ask I to and agency regulations look forth, be at to and that. so the never agency primarily discuss is generally receptive to to details the Type the designed meaning we the

very our view crossover comments, as the with in from hear think, we've to an release, requirements? release submitting as the TRANQUILITY-X would that said response to I agency's end plus been they're to of Schirmer question, symptoms signs. submitted different familiar never in we're said say said unprecedented submission, I package the data that my breadth I given with the FDA data as a has in the very obviously three terms characterized how As primary really in what the test. think I efficacy does prepared We're of is, I data, I question. our fulfill eager

of look I reason is If the on analysis analysis. is today, correlated the labels Schirmer you test dry that particularly and the responder symptomatic most And for is improvement. that responder disease think the at exists with them

test be in at Schirmer correlates or and to time responder they're agency's we've to all the and same symptom So time a about have symptom perspective, the in breadth sign least But the from hear what the analysis very to Obviously that's It's going the same at at an is a lines. something the very with they one. posed say along those interested eager seeing. of question submission. the

Yigal Nochomovitz

Great. much. very Thank you

Todd Brady

Thanks Yigal.

Operator

Shi a go Please we Jefferies. Next from have question ahead, Kelly Kelly. from

Kelly Shi

Thank you for questions. taking my

as to applied So for remember GUARD correctly the dosing than III XXXX the PBR, if trial frequent there rate, the I. Phase more be rate? has bar what observed success the well point, been in Any to attachment Phase regulatory impact the should and Thank on on as impact end I you. efficacy discontinuation And endpoint? real on efficacy the the rate also,

Todd Brady

Kelly. morning Friday. Happy Good

in variety think we're the continue posters. particularly I severe of that in more obviously, episodes of happened number interesting With and that of there are detachment. regimens we severe the severities of terms more form what the trial, is forth less disease in we're greater theory the would disease. that trial. are for the in and and about a dosing. more data And, the GUARD PVR reason is enrolling question is since the more The that announced XX the Your started injections more so prior presentations than GUARD require the is using GUARD frequent and publications dosing because in what's

giving think that's of that what comfortable But trial. we We're number may than worked to GUARD I will the see practice, time. have less dosing in with be the systematically is injections frequent over in injections. XX we're out quite

patients an acceptable, they're know much that has is rate going of lose discontinuations. reason that been seen with issue haven't discontinuation Kelly the think I we sight. Our to but their really And too for

lose everyone be what such coming remind which that minutes over in the of retina detaches one sight quite prevent And PVR. retinal is it of sort when curtain eye, to happens frightening from matter vision. there that that permanent I to detachment a really dark you Just is often due your are recurrent eyes of to down occurring loss in if like patients is would And suspect. a thus keeps Because again. motivated reoccurring, can

guess back forum the agency. from the the results now I the experimentation terms continues bar regulatory outcome year, public come GUARD. what the in the see the to or of that I PVR, this be have think have released posters, safety GUARD second the in GUARD presentations, is, a the the C regulatory been what have And that Type We'll data the data results. less meeting question published and I interesting from of the that addition is think grow. real-world In and amount bar previously, to more results of efficacy of said will in the Kelly half the of discuss another methotrexate from consider with My assuming And we we'll literature, discussion. positive will to FDA that

data rate to of rate The earlier, should care, of see. standard the is results is XX%. key relative want the to provide will GUARD re-datachment say that safety detachment primary which As GUARD retina FDA I or the mentioned I of endpoint about

or three studies rates that large to the and at. two looked are If rates have PVR about been XX%. those literature, are have typically you Detachment there re-detachment go in

of GUARD. our GUARD. arm So the XX% the arm non-treatment be treatment is lower in We'll to GUARD the than at of aim also of versus look arm treatment statistically

under really there. any However, powered detect differences we're to

differences to randomize becoming to the to increasingly summarized for being convince all to given patient be treat. the high idea going The methotrexate those at treatment it's primarily level. to now available surgeons a difficult think data are no I that's that

Kelly Shi

Super helpful. Friday Thanks happy Todd, too. and

Bruce Greenberg

Thanks.

Todd Brady

[ph]. glasses you. for Thank the Thanks

Operator

BTIG. Please go Tom ahead, Shrader from Next we question have a from Tom.

Tom Shrader

XXXX stay guess Congratulations. morning. the I on Good theme. we'll

everything? certain drug. cancer are will for you a have be and and drug have Just And you equivalent? points same I that formulation quickly, price prophylactic a dosing the mean the also are it you

going formulation is looking do So, at? with commercially Just think price? or to less you it more be on one what we're

Todd Brady

Shrader. should. regimen is yes. I answer different. -- that dosing Good probably formulation, the How's The morning, Dr. Yes, is you? concentration for yes. Same same

As I response in over mentioned that's PVR. to dosing good be about is determined trial the Kelly's injections. to the evolves I in time, that How question GUARD XX to think, in regimen

in many some but Now, of more their patient. of monthly, patients To dosed lymphoma, the are and lymphoma or depends less for on lives. dosing physician the regimen the rest the extent,

think say, the unique So the formulation is that And advantageous terms vitreous sure. to I answer -- we in relates for one. this would and yes compatibility, which of again for is

In internally. our depends to groups Part is and on throes determine of of our groups determined. pricing first. pricing pricing, market to And of here obviously, indication I we're be with access terms in and think the which research other approved that's methods research

Tom Shrader

All right. you. with We Thank Great. were happy yes.

Todd Brady

Thanks Tom.

Operator

from from question Justin Co. Please Oppenheimer a & is Next Kim ahead. go

Justin Kim

up Hi, initiation needs those team. and for? studies little work good done to taking and of curious tackling about Todd the clinical for Just XXX. more discuss and what Can trial some the Maybe to to running. just getting very Thanks leading a up bit talk blocking questions. morning of ahead be you

Todd Brady

platform. ADX-XXX sure give over the the you public years credit systemic And Good support For I personally of forum -- morning in the your want and Justin. to for a

We approach should change inhibit but we children. of dysregulation, is you're of the disease in with children large approach say on is applicability a the in I diseases. You condition in seven an diseases, obviously And because that single expansion subject turning now advantages. sort them to for think and growth that stunted kids, of RASP four-pronged off or and volume that's when is award would We're right toxicities, corticosteroids to especially safety, inflammatory RASP off a it really that Steroids two modulation eye protein of rare program And where significant you first II activate currently exhibited modulation of a hormonal turning and and syndrome glucose modulation that change of on are treat a systemically. our to up affect growth, growing affects things beyond does we not been some then disease. mentioned Phase in two RASP safety appreciative think the pick think what renal and is children. the wean of significant been two. diseases analysts of chronic XXX we're particular were is as advantages. the minimal safe MCD, alcoholic forth. the one minimal of reason directly safety hepatitis that or believers the cough big analog has down that in theory, interested has with profile Sjögren-Larsson exhibited reproxalap And and from ADX-XXX. instead the corticosteroids. The dysregulation, of primarily children that problem have needed those often so dysregulation, bone cannot and two one

as that. ADX-XXX So, soon to may the idea as is to get children steroids be do a mechanism possible off and

trial. that are similar an a investigator on with then syndrome Sjögren-Larsson change absolutely neuro there the for submission. Syndrome although disease as very received No cohorts community is really a will I IND that. thrilled Sjögren-Larsson, think the these is disorder we've So, And or for MCD that primarily put so largest world. by SLS cutaneous one adults an by about be IND has we're children well. an response renal minimal affects Sjögren-Larsson discovered the with therapy for and far SLS. molecular sponsored excited the and we're IND approved Bill requires Rizzo genetic the story, of The Each obviously of in that some SLS who just IND from forth basis biochemical Aldeyra and

Justin Kim

sufficiently follow-up there, clinical other you similar approaches meaningful in is benefit and of as Just well sort for steroid-sparing as indications? a think recent with Great. do M&A Great. just potential Maybe maybe patients? MCD of that activity curious, light

Todd Brady

Yes.

the I think indication. on it depends

going severe point, forth. exactly and matter I not Minimal goal If to your off in of biotechnology many so Steroids steroids steroids, think The disease Change some effects maintaining hammer, of side are for while Disease. companies for which children. like had they're steroid-sparing. inexpensive, matter my these of what with as as effective. many To For do have take for unintended them that's a the control my diseases. one treating they children bit acutely little to be a we're the with treated soon years is variable and or are would and steroids patients may But results. that steroids, focused adult They're challenge with of possible on get for ADX-XXX diseases

Justin Kim

Maybe in for Understood. lastly stick just I'll reproxalap. one

any on safety of study. remains of track filing critical time sort on path, whether lines? dry And updates the say? the let's for eye the Just it it's whether And sort on

Todd Brady

on safety remain track. The trial does

on what the actually is meeting meeting, But the One of the quite with agency anything those questions often be eye how good which are of for we're the so like that progress particularly patients patients always drug. when trial. they with XX drug diseases on safety the pre-NDA we'll want to thrilled asking And prior and for in to format months. episodic. does XX difficult to data, news It's at on see keep this forth. months, It's are point stay at dry

maintain a reproxalap to some healthy spring. eye fall, worse the number gets a in able we've to patients XX always dry know, our in for of more summer, It months the humid. very in extent which a knowledge, aside, the because it's gets always on it's it is good you sign. to good Safety the sign. worse As But been And winter. in gets better

again And with with the pleased safety right we pre-NDA trial. heading we're think we're into meeting progress. on the the track So

Justin Kim

and Thanks on congrats question Great. my taking for progress. the

Todd Brady

Justin. you, Thank Yeah.

Operator

Next our SVB question from Please Marc. Goodman comes from go ahead, Securities. Marc

Unidentified Analyst

Hi. for Good Thank us you there much. remind so more And specifically limiting your the about in ATX-XXXX morning. and for will color of And conjunctivitis. do whether was timeline you NDA This regulatory steps? could any some you also if the PVR? and is I us filing of Mark. now after the filing you strategy on think can reproxalap the give allergic just and [indiscernible] wondering, pathway be

Todd Brady

of has What pollution And pollen in increase prevalence companies a thank And tens asking continues second world in companies. level think, and is unfortunately. the Perfect. It's about disease one-third is disease reasons of us is for for have other the mostly conjunctivitis. to One in of a growing ton of at developing the affects about untreated. interest Perfect that by of couple increasing. reasons. I the I is nicely the growing that before questions dry it's of reason a reason, disease is people. duration, is prevalence. for for variety the and is and level global in about increasing drugs. millions and Dry because which of conjunctivitis, pollen pollen. allergic and Aldeyra there's weeds, is growing affects received promoted It other come essentially allergic of been warming. And dry season [Indiscernible] increasing the grasses which more plants forget growing means That is pollen-producing of people is you And

it time that reasons that, only of you that's that corticosteroids, aware I and which That ago, some mentioned from because your toxicity short-term kind I optionality. that a on affects aside getting due conjunctivitis. I allergic a I'm saw can mentioned. are. if for to reproxalap is they in said, basis eye both And is Reproxalap drug the just are use allergies it's worse, only think dry unique you headline has the that, As

allergic that conjunctivitis. about Asia it idea At sNDA conjunctivitis is It is that, conjunctivitis. allergic exists supplemental year comorbidity and paper would If this relates that eye said dry – allergic optionality supplemental results The following an potential NDA real the there's as a year very another or submitted this a is the disease dry – eye have overlap submit to XXXX. out a disease make our that point, Now, for successfully timing eye conjunctivitis. sNDA disease a released what's two approval to and dry between overlap in a of interesting INVIGORATE was between dry detailing is we this sense as paper of XX% as is allergic X then INVIGORATE XXXX for NDA disease. eye

suspicion combination PVR without from the a mentioned trial. our GUARD suspicion real-world for results C once that talked the Type forth our GUARD the another Type data C referenced question, that data informative to forward. having think Type will I path out That previously, of have meeting the NDA And in C so we'll interesting PVR I and be FDA. the I with the regulatory said Regarding as is FDA of publications come the would existing well meeting, a literature as meeting earlier as be terms

Unidentified Analyst

That Thank you so helpful. was much.

Todd Brady

Thanks.

Operator

Please next & The Laidlaw Company. Yale is Jen ahead. from question from go

Yale Jen

even and when thanks the and mainly earlier center studies? and the multicenter study at study did questions. will the current could that morning, single you study a recall also time, we maybe study as for center mainly be Good SLS the or pivotal be the I that taking should anticipate

Todd Brady

on was a Yale. disease Many we that which that reproxalap symptoms topically burdened are neurologic. That's and had we these aren't worked previously that by their that is of with long dermatologic you, large that eye Dr. effective. question forgotten and I Sjögren-Larsson have Sjögren-Larsson data with allergic Thank great that patients conjunctivitis before many ago, patients a investors Many and with syndrome. in challenge years dermatologic The think Rizzo disease. of with though we've treated Sjögren-Larsson just formulation dry

ADX-XXX not been symptoms benefit the Center. to we others. Dr. therefore, the but and aldehydes pharmacologic an replacement symptoms. a this Syndrome relationship in signs disorder The that a That fatty perhaps aldehyde and size obvious. therefore only a with inhibitor has enzyme enzyme Rizzo aldehyde sort to Sjögren-Larsson treating is In dermatologic common the is centers potentially, and systemic Dr. some the to that mutations fact, most disorder. think dehydrogenase, In And Rizzo ADX-XXX by published is including caused ADX-XXX aldehyde work sense, by of at which restricted neurocutaneous point and is binds is even metabolizes would approach therapy. neurologic aldehyde SLS of an is of of fatty number

largest what The said Dr. world. discovered the disease. of has patients earlier, Rizzo As reason I cohorts is in we believe of for physiologic SLS he the the basis is that the one of

I see have And data thrilled tell this the particular can to from Rizzo. excited We'll with continue about he I approach. work that trial next So predictably, results. this we're is you Dr. can't to year. wait to

Yale Jen

that question the one have with probably pathway equivalency the PD Okay. the Great. are maybe? what of to or process from to which previous around And PK -- the something the FDA That's see equivalency is very something in a you is next decide centered helpful. or follow-up the the sort filing the discussion maybe and nature of mostly will PVL of

Todd Brady

Yale, question. a I PK/PD don't it's think

should injecting the The I of of the a concentration the more versus volume on PK/PD net the think amount it's obviously ADX-XXXX, less the amount but intravenous aware for more compounded basis. roughly higher because at safety a We're weight drug drug we're a volume different concentration that's of eye methotrexate. concentration. into is is compounding well the be question. same at of a is same result The injected lower of

never the formulated matter to think matter. vitreous. So I to Because our is don't is What the really to formulation novel mimic methotrexate will in has been safety. that going think PK/PD knowledge is

opinion, as doesn't to pH think the whistles that that eyebrows is to of what I may just my formulation the the matched to they'll guess fancy with should important the changes one, safety advantages. here, confirm with focus think and But anything agency. raise just the safety have being that job the my priority, those being kinds I agency's I the of say, a have bells another wants characteristics such there safety fact nonetheless, intravitreal to are being that's vitreous be the would and if mentioned, formulation. no of on and Yale. time, that to And tenacity have would density regard In concerns agency formulation confirm I in At a injection. been at same is Now various confirm safety another,

Yale Jen

last maybe chose And both the reproxalap to that here XXXX bit the that and a and Great. question looking if Okay. yourself. approved market it little you forward

or typical point sales two Just in separate fact? that the curious, quite are overlap for or be for would the the call same drugs

Todd Brady

surgeons very I about ocular imagine. that talking is that surgeons treat inject particular, that retinal in and really surgeons retina and back office XXXX, thus, not be There I by there's are The and to offices reasons. in you surgeons the anterior retina with sales that patients about treat of dry sales the That diseases. getting engage news, hospitals and the on kind They're XXXX physicians office of basis of a lymphoma patients a focus might distribution on ophthalmologists reproxalap is disease terms approached regular hundreds aren't don't diseases XXXX versa. good access, I of the segment would disorders. front PVR on the in particularly number retinal hundreds We're is methotrexate retinitis the ADX-XXXX are few methotrexate that pigmentosa. injecting of the for retinal some limited think, and is in treat that awareness diseases et terms good Typically, the vice that of around eye as intravitreally. rare And though and in and side both same. There there distribution cetera. think, rare synergies about for drugs believe

Yale Jen

all That's progress. congrats the the very Great. on Okay. And helpful.

Todd Brady

Thank you, Yale. Always the pressure.

Operator

registered, We it to [Operator no I'll questions have more Instructions] so Todd currently Dr. Brady. over hand

Todd Brady

Thank endeavor continue time the progress, of you that look our patients very updated forward And much. as lives your morning. this keeping always, we we unmet improve you medical significant as I appreciate with all need. to on to to

Operator

call. joining. for This lines. now concludes you today's disconnect Thank your all Please

Aldeyra Therapeutics (ALDX) 5 Aug 222022 Q2 Earnings call transcript