Thanks, Anthony.
program. OTX-TKI a containing with me developed implant a Let bioresorbable hydrogel treatment extend our on for an begin as wet axitinib of is durability back-of-the-eye candidate product AMD. being update the to
both The escalation date. safety no favorable two well third subjects and multicenter, open-label dose cohorts two and currently demonstrate OTX-TKI being cohorts generally activity ocular and X first with a in cohort adverse has OTX-TKI patients. safety with enrolling in preliminary assess cohorts tolerability To changes. is in date, the tolerated from dose of is first been well data reported functional to profile that to serious another trial continue as the enrolled that have anatomical by a to events conducted assess we as We that biological Phase Australia to clinical the designed measuring
While dose the early, greater as data a cohort. first interim in compared there's still suggests a response evidenced higher dose clinical dose lower cohort that by response the second to
without previously one treated with Additionally, patient seeing nine rescue. to needing now out with OTX-TKI good we treatment durability after are anti-VEGF injections, monthly months
While next subretinal to the profile is safety, additional upcoming fluid. still a We plan reduce drug of provide activity durability interim week. data with injection shows on Ophthalmology and/or emerging, we the that are American intravitreal potentially Academy biological and intraretinal data of at can TKI the conference product pleased
Australia middle track this in an the and exploratory announcement, submit Beyond U.S. in trial by in FDA XXXX. wet to the a with we Phase initiate year on the dosing allow of start to IND to X subjects of expect the are end us the AMD data to to
our of of a hypertension is glaucoma implant long-acting of travoprost primary delivery patients the months. with a four to duration to six Moving with intracameral open-angle treatment ocular or program, target drug OTX-TIC for glaucoma
implant. controlled showed We tolerability that of and in of a Phase in prospective, subjects trial non-study X, U.S. the decreased subject months clinical open-label, activity, two had a placed data decreased to single the The Data months consistently receiving in biological the for to eye. extended OTX-TIC in enroll the current topical XX continue duration a for IOP with of dose-escalation one from with durability single multi-center, many safety, OTX-TIC. IOP IOP first in an subjects nine to was comparable remained that over cohort standard to patients evaluate shows enrolled and the six implant care, travoprost fully
we low and signs potential time faster We're middle surface four, intracanalicular biggest of targeting OTX-CSI, of smaller eye, conjunctivitis. two programmed believe extended dry of and over treat program In eye with last symptoms along cohort for XXXX. eye X eye one same dose approximately completing period. of have burning. enrolled in clinical enrollment an minimize announced as is implant and cohort Local patients. In which time, are disease. one three, of dose. a new same terms is of surface, fully trial Phase of lower topical ocular next targeting By we a what of the a duration degrading occlusion dry steps, initiating the We're OTX-TIC dry of doses cohort the cyclosporine two treatment allergic the has programs, releasing months cyclosporine we disease for OTX-CSI for ocular also include dry the insert have with tear complaints punctal treatment three patient the which and is eye to production and a the our making of combines disease over chronic which progress the patients OTX-CSI preservative-free increase designed programs; with to modalities to OTX-DED, stinging quarter, dry to is short-term our of cyclosporine, which for an products release implant
XX-week X.X baseline be tolerated mean millimeters events were and of events test at the study approximately no or provide As an eyes XX intracanalicular for tolerability, that October, cyclosporine U.S.-based more data the over symptomatic open of of label, with Schirmer’s tearing adverse were In than by or production designed improved from XX vision All XX. blurred X.X reported activity onset irritation, from relief completed serious subjects, durability millimeters at weeks. observed. announced rapid measured adverse evaluate reported. Tear to The stinging, there early Phase to insert, observed inserts as subjects five period the values no was drops OTX-CSI dropouts biological safety, alone. and week we in single-center patients well in may trial to X or
eye of eye symptoms a scale analog as study to eye as five an symptoms of or signs of millimeter to XX-week was for of Schirmer’s X of One XX fluorescein had XX week to and baseline, in disease and mean disease XX. a X in dry Subjects improvement disease at signs dry of or baseline, measured XX a score, as equal corneal greater OTX-CSI improved a total dryness scale week improvement eye subjects XX, seen as staining, increase a The week XX, of visual the than and OTX-CSI of subjects at mean mean action over measured on two onset improved at at both X.X baseline a XX% mean to on treated period. continued dry of at scale severity from XXX. value by value of in a score the of weeks X.X of demonstrated of early to XX by an with value
evaluating of who XXX eye corneal this subjects signs followed of as test, period masked, eye measured patient symptoms Based for measured OTX-CSI as Endpoints the recently formulations insert of to dry visual multicenter on about the the the the the two tolerability visual Phase excited potential eye of the vehicle trial was include of X disease and staining, eye top severity we U.S.-based, free clinical tear rapid analog score. trial production will in option patients and therapies available that analog receiving half from by by onset XX helping XXXX. more results from measured first disease the fluorescein be dry clinical frequency anticipate data benefits of the announced dry and in in vehicle-controlled, of Phase randomized, different with compared dosed scale a as with X weeks. the trial, eye by approximately scale We first a score Schirmer’s X potentially and dryness line on currently this We’re receive market. for cyclosporine Phase preservative hands-free in dry greater action
dose a dry OTX-DED, preservative-free dry short-term a Our the dexamethasone intracanalicular low second product for eye with of is eye, disease. in patients treatment insert,
symptoms track the data the incorporates patients the DEXTENZA, therapy. for with with experience surface smaller into toxicity. be new steroid submit have DEXTENZA with the it can plan sNDA, IND this in in and with pressure advance expect patients adverse end an October PDUFA dry eye XXXX. quarter and OTX-DED package Because package size. in or evaluating remain While allergic eye for been insert has these used we associated as unmet the profile would therapy highlights first a a and conjunctivitis, track believe then and events represent OTX-DED same dry if lower the of candidate They of current we treated related product approved, are move conjunctivitis a stage hands-free dose patients directly X to the steroids on a episodic a itching intraocular rapidly these non-abusable, and could on disease late active the trials Many of OTX-DED inflammation. of of we flares a with label have is if U.S. opportunity to and dry which signs Overall, chronically. clinical to FDA In drug of their trials. by clinical to ocular standard dry file Topical DEXTENZA which application likely date preservative-free targeting ocular our long need end data of of into off compelling preservatives use used change to that with offers in result clinically also product flares to such we're onset, eye in elevated for lower the eye remain XXXX This treatment the would believe program lead one-time, cataracts, indication. to concentration We with the disease rapid XXXX Phase the dexamethasone, by in-office allergic sNDA these potentially to first as physician-administered, a potentially a able long-acting, XXXX. safety care of patients. an hands-free for
in requests interest active over XX areas call and would and would like excitement of be add financial that to over need over like are that have subjects, enrolling I in two Lastly, that trials evaluating third to fully our DEXTENZA are review currently results. investigator-initiated unmet there XX back They Donald continues with significant trial including submitted. enrolled. now I many to quarter the to turn investigator-initiated to
