ALDX - Earnings call transcript Q4 2021 | Aldeyra Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Aldeyra Therapeutics’ Full Year 2021 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 Chief Financial Officer, Mr. Joshua Reed. sir. ahead, go Please

Joshua Reed

year With Officer Dr. we of reporting for press everyone. copy XXXX. website, release call our contains and issued Brady, the regarding events Please the forward-looking section press Chief investors future release media the results this and financial Aldeyra. Executive available statements Aldeyra. is of note performance our December the me that on and morning, XX, Todd A is President a ended of Good This www.aldeyra.com. conference of morning's morning, future

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

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

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

Todd Brady

the And in XXXX an year we of what will for everyone. the promises emergence a Joshua. the will diseases platforms platforms clinical only therefore good we enter for retinal treatment underappreciated late-stage systemic you, the not and dry as rare be but our that rich disease, milestones Thank we and morning, be underexposed, for modulator period eye these build broadly autoimmune and XXXX throughout are ADX-XXXX also of of We beyond. awareness for regulatory certain inflammatory exciting successful attend of to retinal reproxalap and and Aldeyra platform systemic RASP catalyst development completion for treatment highlight that our hope diseases. believe aggressively and to of

data Day from XX topline ADX-XXX, increase goal RASP X first-in-class asthma of The of psoriasis, indeed ADX-XXX March we to is of trials our term. systemic platform trials in modulating Phase occur are COVID-XX. The immune the plan Our our on to plan which threefold. Aldeyra proof-of-concept R&D Therapeutics during our recognition modulator and will near proof-of-concept announce oral

RASP humans. an tolerability time demonstrate orally modulator what has to represents first to for a First, acceptable the safety been and profile administered

small varying trials of of across related to biomarkers with indicate third, topical a transformative broad ocular our and the systemic molecules retinal new for potential inflammation. late-stage to expected disease consistent durations creating designs to of complementing from and might RASP with pharmacodynamic And disease clinical signals modulator states. with activity a Aldeyra therapy, and commercial of levels have what be ADX-XXX variety and to Second, doses, ADX-XXX our trial of elucidate and from range be opportunities activity programs. related platform

potential research modulation and behind to for particularly leader Phase the welcome Thiele Division as of In future Thiele our initial describing ADX-XXX X understanding the treatment in look a broadly forward the programs. is Internal and and Nebraska novel of we're in other indications, inflammatory a Professor malondialdehyde, the clinical to Center. potential response. Rheumatology his Day. potentiators for of on RASP Medicine as ADX-XXX, the inflammatory RASP University the Dr. for to is science Umbach of featured at Geoffrey unique brings We a the Dr. for Dr. acetaldehyde He speaker the excited the outcomes R&D Medical RASP addition Thiele approach of as diseases. of the perspectives of

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of and INVIGORATE chamber sufficient separate statistically and hour following from study For to over the in to reproxalap trial symptom XXXX. conjunctivitis, that trial conjunctivitis, sign initiated exclusively X including year. trial, and broad the experience, redness X allergen case of compared was symptom effects that reproxalap Xiidra significant assessment are the allergic of a reducing key trial. were The and In both reproxalap improvement numbers Xiidra. quarter of as the administration pollen results with the in The was results X was XXXX. of superior randomized, eye the the significant X trial. first demonstrated INVIGORATE of in allergen expect allergic INVIGORATE Phase INVIGORATE one winter, itching announced the of substantially double-masked a Phase ophthalmology which chamber environment, require trial To design Therefore, in April winter of in superiority demonstrated to often conducted we X a seasons is ocular this and vehicle respectively. published drop the crossover INVIGORATE trials of enroll clinical ocular over avoid INVIGORATE was confounding endpoints, two last year patients the to statistically sensations in similar

systemic has mutations these ADX-XXXX in second are diseases In in is incurable Part XX% therapy. surgical X January, in ADX-XXXX of we Along is Center PVR, and compatible retinitis of diseases. animal This of vitreous, therapy. of and specifically are Aldeyra's are with today, ADX-XXXX retinal X PVR retinitis patients primary ADX-XXXX estimated four in diseases formulation rare of with approved this and of expected and patients at responded in GUARD to loss over Medical safety of those this lead pigmentosa knowledge, Thus, year. especially disease the Phase which rare. of commercial to which months. to disease, the addition report initiation the we a half unique represents with enroll twice specific and to in an failure committed enrollment advancement of lines, due to from the to the fluid patients the Results genetic expected is that detachment trial will trial are detachments. the first of a to methotrexate Many be to four of pigmentosa, ADX-XXXX diagnosed to of proliferative another disease of methotrexate sight in or Phase retinal cause X% retinal the single-center trial to loss X lead expected patients, retinal vitreoretinopathy of treated no pleased Duke effort during half blinding be second yet potentially designed X opportunity. that of tolerability leading our will treatment. To significant development the of are am year. ADX-XXXX the occurring eight can three trial, back Part to open-label poorly with eye. monthly evaluate The I approved patients In injections the conducted GUARD a models Results after retinal the receiving announced University period of intravitreal completion monthly receiving of vision no

diseases. For received Together In injections retinitis three current rare pigmentosa with treatment lymphoma. orphan of care drug span of example, platform FDA’s retinal off-label ADX-XXXX ADX-XXXX PVR, and the indications the our each for ocular designation. has standard U.S. indication, methotrexate for the are

for after which Now, in of disease. platforms recent and our progress for I’ll over back review, developing the financial summarize will treatment potential clinical our future to immune-mediated call turn the Joshua I the novel

Joshua Reed

reproxalap, Todd. million. will equivalents cash current be you, cash $XXX.X we equivalents and December Cash Based plan, to cash XX, sufficient XXXX, were operating on and existing our believe as Thank of that fund of development currently projected the and approved, XXXX, including product through of and systemic our end new commercialization continued drug expenses and candidates application ocular immune-mediated initial if potential diseases. operating submissions, of

and compared for Net Now, and to due let compared consulting period in $X.XX XX, XXXX. expenditures. months review loss XX primarily in the $X.XX XXXX. for per $XX as for million, increase million, the $XX.X $XX.X the a Losses and $XX.X million our million net resulted share $XX.X the is increases trials operating me General compared Research in from loss $XX.X million $X.X is was costs. and with and XXXX. expenses for million have the general insurance million of or same increases of expenses expenses. Total development were total for comparable of clinical primarily to XXXX. per with cost were period the administrative The million development period million legal, expenses with were $XX.X clinical share and or million, of in operating same research as P&L from December programs of administrative compared the ended of period related XXXX. with well same research increase and in development $XX.X expenses The $XX.X

the I’ll to Now, Todd comments. call for back closing hand

Todd Brady

eye aware disease that a enter of reproxalap success Thanks, potential approach therapy. the shortcomings therapeutic investor many strength Joshua. of addresses XXXX entrant be of is variety of while from novel and we therapeutic clinical position a that market We community and currently next the available Interestingly, believe the to of of financial the a dry across platforms.

and to present beginning and catalyst-rich. pleased indications We believe opportunity and that of also is month Day Aldeyra that treatment for diseases. the continuing state and am our this new execute to clinical We retinal systemic retinal remainder data for and believe regulatory in our under future mission recognized develop progress XXXX value we throughout to R&D accretion on to I announce novel we reservation systemic disease unique and as without at platforms therapies of our expect a in beyond. continue immune-mediated the are

and to is our I take strong, that, questions. will Our Operator? happy Joshua potential your unwavering. be and With remains commitment

Operator

you. Nochomovitz line question Yigal first open. your Thank now comes Citigroup. from [Operator for is Yigal, Our Instructions] of today

Yigal Nochomovitz

Hi, taking curious, I’m you’re Todd and Todd, XXX, looking Joshua, psoriasis, asthma, just the thank diseases, you three very at much questions. for COVID-XX. on

sense Thank potential one for you to to you. as where other Or more why the is diseases. running think thus inflammatory and unclear the effect of three really therapeutic evidence Just across wondering is have likely them a it work is you others? if you’re is do these studies? than best words, the this In

Todd Brady

didn’t obviously we THX Good or conditions. reproxalap is a to years presented. the your reproxalap THX the is I ago, data about board. And been we time, a work modulator. more worked an for consistently, type my similar we in would reproxalap, which And a thought expect disease, as is ADX-XXX the for type RASP is question. better a think It entirely expect not as work to really relative the it of and are until although you about, eye I conjunctivitis, dry question was I remember reproxalap. across morning, to clear at demonstrated reproxalap thank condition, a Did something allergic in autoimmune the is Yigal, be better It’s which of question allergic also same reproxalap. we’re lot answer has know which closed

modulation potential to influence It is activity I optimism I in all of think have a of believe we to It upstream. kinds the RASP and proximal. that has And reason therefore amount reasonable psoriasis inflammation. we’ll that have see is asthma. both

of modulators B, to But disease; ADX-XXX both I’m data. is as from is immune arms fact that we different of different would believe both and see and affect THX well, if infectious disease. is the THX. and COVID-XX COVID-XX reproxalap kind is a us. likely that a asthma for eager Now, approximately and is that the the is, experiment upstream, and animal. new an then COVID A, notwithstanding That some infectious COVID-XX inflammation present RASP involves we it system, is in effect psoriasis that an

Yigal Nochomovitz

That’s wanted dry a it. helpful. your obviously, And Got just very, meaning, heavy symptomology thoughts between very eye get I and there’s in to conjunctivitis, allergic very then AC. on latest overlap

if condition? thought physicians wondering but do a you’ve prescribe know perspective, in From for think I even this a the AC give perspective. file so, And need past, you to you commercial just about latest this I’m an you can to get to reproxalap

Todd Brady

The of variants between Yigal, very if your related. I of substantial. often wonder inflammation the a one. and eye allergic point surface same allergic is are good the are disease dry and closely disease, indeed is conjunctivitis variants that dry eye ocular overlap conjunctivitis

conjunctivitis patients patient related, both and providers that dry presents a diagnosis recognize healthcare and diseases the two one many with think is many disease think is I therefore, And surface both condition. process allergic condition clear. of when between for inflammation I healthcare for will ophthalmologists to not optometrists are that these ocular differential providers conditions elements another and prescribing often prescribing and have complicated similar believe that

file whether question. Now for submitted is for occur the for we whether dry which conjunctivitis, disease, NDA to allergic we would different conjunctivitis, I NDA subsequent a think allergic

to a with think reproxalap, not on disease that on may in depends we answer we’ll future. depends dry data. I and It later different potential have that partnership or launching in it the may the on question company have

Yigal Nochomovitz

Great. Thanks, Todd.

Todd Brady

Thanks, Yigal.

Operator

you. Thank

comes Shi line Jefferies. Kelly, now Kelly question next Our is your of from open.

Unidentified Analyst

questions. And thanks for [ph] is this taking Hao my Kelly for Todd, Hey, Shi.

efficacy. was test trial, So, really the day, one it Schirmer’s one see is onset, my you very fast first basically the TRANQULITY in the result for

some there’s you durable explain fast MOA think durability So, you from if the the then And can of point view the is you that of effect. require onset do the for FDA action? and anything do think effect evidence of may

Todd Brady

broad can dry want question NDA the we RASP only And I nature important that signs of RASP Thanks quickly approach binding that question, the as something to questions disease. build your modulation, affect Yigal’s we for reaction submission rapid. the about of Great. are is [ph] a for consider and upstream reason on reproxalap Hao variety inhibition not to those is of is one believe drug question, reproxalap but different works is involves the because a RASP. why inflammatory it of also to so of to is mechanism And diseases, and that symptoms chemical eye the

component effects accordingly, of us numbing of not and physiologic a chronicity, that chamber drug modulation duration chambers, prove dry for to with disease. which of redness the anesthesia. very changes situations which effect is As exceedingly fast there and vitro is our we FDA’s in in to to least can your presented need of is discussions conversations FDA, that reaction that demonstrated minutes is eye activity signs, that within not what’s What and rapidly. now a that per series then able guess is and test an the trials ocular The the rapidly. can that treatment that is is we drug reaction, rapid beyond on our discussed important is And the our surface disease at and the we’ve is that our that’s dry the agency has on drug Schirmer in in physiologic in with important. and happening the of run signs, deck chemical exactly signs to been demonstrate a previously, symptoms tissue the occurring on part both eye beneficial allow the signs beneficial prove of not very position anesthetic signs simply the be that corporate has is the Based

developer are relatively standpoint, a advantages activity, rapid And of at allow I inexpensive. a think they a very the They importantly, from most reproxalap from to signed standpoint least multifactorial. commercial are of us are demonstrate as the drug. of chamber They fast. trials

Unidentified Analyst

Todd. you, helpful. Thank That’s very

follow-up. a quick Just

X status So, one? that that’s crossover in trial to for also, the the opening. optimizing And you want of Phase and measurement, just trial test check about one-day your the Schirmer’s trial RASP mentioned

possible. design, a understanding the to bit and trial about if little the Just get timing

Todd Brady

later, Right. is dry to the assessment that assessment than The is in and of assessment assessment, clinical all RASP complex as described is data these current in signs. have aggregate RASP of RASP previously, plan data complex disease organize present the occurring more than The I trials. more and standard the

completion TRANQUILITY upon each assessed each announced up crossover That trial patients you different future. trial be patient trial dry trials dry in times for different receive the a manner. in in eye parallel in glad chamber data vehicle the conjunctivitis. and here alternative in a at RASP group and drug we those either will chambers just patient eye allergic The crossover So, is asked disease. and separately the that I’m unique in of are trials receives two have methods the random other in brought trial, crossover drug. TRANQUILITY-X, TRANQUILITY-X Schirmer chamber you with signs slightly and of eye We’ve successful that in measuring A test vehicle highly to is been or will dry crossover and is order. about

trial, control. subject each subjecting the is to statistically or is published because chamber. test INVIGORATE her trial This subjects objective prior article half to know, entering recently a been X subject a are approach X allergen chamber trial variability. subjects INVIGORATE is eliminates and subject ongoing which you As each it That Phase powerful ophthalmology own clinical to a his in and the has and

have, crossover dry disease but seen We eye chamber our trial. to a never knowledge,

look highlighting rapidity dry that’s this test for one as on the eye a conjunctivitis a in is those dry later reproxalap. single again, TRANQUILITY-X, on times the we’re dose such for of is and trial TRANQUILITY-X. Schirmer and community. both NDA for mentioned trial and the TRANQUILITY-X comments final fourth company necessarily may the be the around on trials to day dosed the to are running is and thrilled not The day, not submission, unlike based be results one-day support a investor onset for the the allergic similar the TRANQUILITY I subjects my the pending four Essentially, the where year is the Schirmer will trial, a on outcome in upcoming disease day. is obviously, trial, to forward results, eye results, believe, describing we that The following TRANQUILITY and there taken We’re how about optimistic of trial. submission, We needed the prepared chamber trials, test successful, NDA though first

Unidentified Analyst

Great. Thank Todd. you,

Operator

Thank you.

SVB now question next from your of Marc comes Goodman Our open. is line Marc Leerink.

Marc Goodman

had of would study can the just us you safety update the the – then the Yes. data if of file. can middle works be there safety an and and And then Todd, year, which mentioned dry give the we timing you of filing the in first for data all, is eye, on you get data. the

able of the you give an a the on does the work when we’re case serve? update crossover an trial purpose before a FDA be are purpose what with get chamber that you completes, is Just you planning us how the Also, it in of after I that kind would Just then us is as to need. backup of mentioned? other the CMC, that just just safety doesn’t is one we And this Thanks. can what going, here, meeting give having idea Schirmer file? us of mean, timing just two just on that of test the that sense you soon so tell just kind doing you trial, you file? clear, number one. other question study can how numbers question making TRANQUILITY sure And the all

Todd Brady

Marc, questions. Thanks, for thanks excellent and the

discussed report per the knowledge progress registration requirement generally I’m thrilled significant chronic issues safety of NDA superb. as a requirements, with a cetera. to regarding commercial for the obviously is XX-month our a trial critical to trial our about the said are required for FDA. any before, often I batches, or We’ve think, is for undertaking that which And The foresee relates safety CMC drugs as both at disease I’ve don’t and investors times CMC CMC trial many to is safety specifically et forget I CMC, FDA guidance. this stability, dry it point, submission.

As NDA XXX XX of completion but for can submitted XXX are all exposed – that least. are you generally, XXX the be the by patients the by months drug at safety that XXX-day final prior those be the the required to update, know, subjects to the addition. XX-month The for to is in needs data, trial, be patients the safety data to submitted

I NDA broadly, able industry across this at and current biotech think as various diseases, point, not retention, but think COVID. Enrollment industry across to the is difficult been life as than the in have disease in again, NDA clinical patients a past on still and trials. broadly, midyear we choices in we safety in on I is challenge. they has case track in as the the disease through some remain not moved submit comments, on phases people are we differently those be based enrollment retaining with we’re But experiencing in are of trial a track industry I or believe to the dry ocular the COVID for broadly for that the midyear trial, challenges many trial Notwithstanding evaluating submission. the only

are one-day the good test the about questions trial wins. crossover Your Schirmer and

I questions dry as question different never crossover which, For chamber we’ve asked serve But backup. because trial, particular, really, answer sure, done either the slightly in than mentioned disease previously, in could our trials we’re trial what as before. been running has knowledge, to I a response How’s to they those think

trial across models demonstrate Schirmer of large packages this one eye with the the different come two breadth different most considers FDA of will the and the disease, submitted test – our that preponderance is the of the dry for designs. the know, our you package expand only in As of of not activity NDA evidence NDA examples are number trial reproxalap the to comprehensive patients, trial, a submitting position drug of crossover efforts but to ever

Marc Goodman

Thanks.

Operator

Our question Shrader now Instructions] Thomas Thank you. [Operator comes your from BTIG. line Thomas next open. of is

Sung Ji Nam

Sung Hey good Tom. Josh. on is morning, and Todd This for

wait redness. on data I for an trial TRANQUILITY-X earlier we the the into TRANQUILITY-X, going patients? ocular concerns And one patients that from of as if low you had a was baseline TRANQUILITY-X the So, wondering for readout read just guys Thanks. was had

Todd Brady

Hi, the trials we’ve to we with described, would expressed TRANQUILITY Sung, relative that good I say, run. two morning. Yes, trial major differences prior

primarily disease of confound to ocular is as spring. trial many and a the pollen was One but in during disease. you that pollen mechanical Pollen, the is even season if or can only irritant cases, surface run therefore, TRANQUILITY allergic them pro-allergen aren’t is know, assessment the not pollen, and the in subjects allergic surface of ocular

significance the The that in lower question your been that highlighted patients into clinical during allergies paradoxically is course, for vasoconstrictors are baseline going I higher the they vehicle scores and occurs tiers, effects a in statistical use of that in or for trial midyear as my we on announcement And TRANQUILITY-X. matters comments, a or for differences baseline allergy say obviously, on is the trial, prepared remain season. would of groups. as TRANQUILITY redness for were of baseline you occasionally for better or which, mentioned other ocular we may major use nonetheless, in scores antihistamines settings. reproxalap and the pollen are of un-blinding track prior other season use have scores monitor resulted trial data reason or Phase are difference But evident from in look the were amongst with than demonstrated I X One Phase artificial than across redness. they of the TRANQUILITY that far, to the the previous blinded X that trial suffering restricted did so basis between the but the

Sung Ji Nam

you. Thank Great.

Todd Brady

Thanks, Tom.

Operator

you. Thank

question next Alliance open. Global Our Cross is now your line from Matthew Matthew, of Partners. comes

Matthew Cross

questions me Good morning for for guys. thanks here. a Hi and couple of taking

used I pressing noted. that in from kind with wondering disease will DED, ahead you X INVIGORATE that and in guess redness the also the overall baseline data So, measurement possibility at was the I and of was of for is two, same there INVIGORATE data the in I confirm score design if you be required upon least expand overlap X, given the think, you given referencing any similarity of could kind redness could filing study. AC characteristics in that here. INVIGORATE chamber of of that covered INVIGORATE in And package we've

Todd Brady

interesting the I dry allergic others between an notwithstanding FDA have primary redness Yigal and somewhat doubt that of allergic Matt. allergic dry protocols. considers activity Thank protocols are the eye eye chamber will disease suspect Generally, in FDA from you. different NDA, disease will disease this eye assessing disease. trial eye retinas consideration highlighted reduction sign the of reduction dry disease. That’s allergen the of and overlap that on dry conjunctivitis the than dry though in distinct I consider call the when conjunctivitis, the a reviewing chamber be allergic reproxalap The question conjunctivitis in conjunctivitis, that

not the disease trial. trials redness the drug different and in build the itching must vehicle only in in the As That enter must allergen to to chamber is Patients dry an chamber, trial, enter which point chamber and chamber. to I in but mentioned be for in environment, response if a patients chamber, your a run the or drug to as confounds entering must the disease But can redness demonstrate chamber has allergy qualify is after the have essentially winter. where the assessment. eye my chamber generally entering it. increase have before prepared trial redness dry they only it the in in Aerosolized the and in for to the redness the dosed, comments, is the Sung's subjects to that Pollen an the question for you have to no prior allergen in reason And pollen has dosing redness, prior entering

So, difference different two in diseases. highlighted nature by protocols the pollen and of the the

Matthew Cross

Thanks. it. Got

confirming largely positive with kind form So, point a of And – there study discussed Obviously, I a to you've answer can explain already appreciate they to repeat the feedback to kind now receive of that, you've a X. and an or just X, your degree is officially around the I plans know from INVIGORATE what was second kind answer maybe why go that and FDA but I of of of ALLEVIATE, repeat better, or this INVIGORATE don't confirm INVIGORATE. similar of thorough if related to that wanted a ahead to of conducted then would shortcoming just was which requests, maybe any wanted ALLEVIATE? in FDA you the some additional design clarify request whether to would the kind adopted

Todd Brady

that. the surface so the the is conjunctival eye with and are primarily well-controlled reproxalap model. ALLEVIATE, discussions to hour thus, after challenge and And in an designed Was administered our assess trial, model, trials not a wanted chamber allergen two pollen adequate was that on Based obviously, antihistamine. the different over is the FDA of to which antihistamines, agency, which or assessed patients is an is directly a

as investigator-assessed highly was ocular the regarding identical chamber allergen from statistically and that different I recently X, amount expect for highly tiering. we of because itching, because takes to winter. that INVIGORATE think, don't allergic the of for today, mostly patients. conjunctivitis I've eye X obviously, itching of the X, substantially in trial reported enroll in two for other expressed XXXX. have winter patient agency also, redness we I seasons and said trials is INVIGORATE today in ocular It previously. significant optimism and the disease. trial Phase protocol subsequent can submission anything that statistically that INVIGORATE for discussed across published and and X, is dry questions, with tiering occur would protocol these often INVIGORATE one timing we've sufficient was the to But considerable a the to of the The the likely will NDA because assessment only redness a that described X significant we've to INVIGORATE. be number I That's as now And INVIGORATE response run a reason

Matthew Cross

Understood.

Thanks, Okay. forward That's the rest all helpful. of look and very the Todd, the year. to data

Todd Brady

Matt. you, Thank

Operator

Thank you.

comes I-Eh of Laidlaw now Company. from today for Jen & Our open. is line I-Eh, final question your

I-Eh Jen

want were study? the chamber registered to – the we for that assume complete continue mentioned season. that Should I you enrollment patient Thanks don't about for the dry you as to taking to questions. just the you study pollen start in

Todd Brady

excellent is that think an I assumption.

pollen apparent pollen to disease pollen out, about pollen a previously, of in you is said of As I is which, as the are not but that pointed data they're with to issues outside allergic to the to pollen. the apparent and TRANQUILITY is dry trial are season, patients also only dry assessment perform think and confounding of terms we've discussed know, today, development, with allergic not call, I with patients disease, during that of start. goal, TRANQUILITY-X terms of factor, you One the as in are

reasonable longer some forward future, I look the midyear the that we'll will think assumption not enrollment, out much very And frame. in again reading that enrolling then completed so, results have point relatively continue in we near and to the we your is time and at

I-Eh Jen

reported the question half positive year? a PVR, follow-up to in that should of is follow-up indication? might on here XXXX One that you this in the data for be second have be What

Todd Brady

late the PVR That's And months. another interesting question, the trial, I-Eh. enrollment last trial, follow-up is GUARD year. The completed six

So, one last the that. the around somewhere in to trial out subsequent and this patient come visit the midyear year, that would last is assume might data reasonably

the that's which a GUARD, it that I papers are online need the conferences standard which thus, for think interesting that subsequent that agency becomes There since PVR. the in My standard positive. a that then an with therapy Thus, don't where treatment essentially GUARD watch-and-wait to repeat. starting you therapy. we access which of approach. and difficult at does want or to to because steps, surgeons care, we GUARD can treatment a data a recognized end occur data. as combination to next are risk and a then I randomized the of of regarded and patients methotrexate we randomized trial think up patient results, in of published for involves randomized an case, in care, a for the to has GUARD is is being methotrexate data either negotiate the the PVR, on the started that discuss we'll watch-and-wait can is like in the nothing. the GUARD, results effective But is GUARD is to It's FDA and have that more the enrolled that guess like future now potential is a enroll been assuming are would end If a patient of ADX-XXXX trial emerged PVR, remains risk as trial no is meeting and NDA therapy, to more approved a terms and receive don't real-world GUARD discussing and methotrexate agency, receive GUARD results after potentially, literature discussing submission subject of up not the has GUARD we'll with is practical – practical to

I-Eh Jen

very That’s there. success Thanks. for great. the the Okay, luck over helpful and best

Todd Brady

you, Thank I-Eh.

Operator

Thank you.

have We further no questions.

Brady So, remarks. I to for will back hand any Dr. closing

Todd Brady

Well, thank you joining our progress. as us look always, for we you keeping to today. all on forward And updated

Operator

Thank call. you for joining today's

may You now disconnect.

Aldeyra Therapeutics (ALDX) 17 Mar 222021 Q4 Earnings call transcript