Thanks, Antony.
back on an program me of OTX-TKI. Let eye with the our update begin
Australia changes. subjects the and that X and subjects OTX-TKI Phase multicenter activity in continued as We in trial in as escalation conducted tolerability durability being clinical assess to by safety, assess measuring functional open-label preliminary well of anatomical the to is dose designed to biological a
micrograms enrolling. This highlights enrolled as used we from cohort three first in at OTX-TKI mentioned, cohorts, presented XXX data Antony micrograms; incremental XXX micrograms; X, cohort As update data micrograms, cohort the XB, XXX currently induction ARVO. XA, therapy, from well is cohort interim with anti-VEGF XXX X, fully which combination and as
to in biological X months We two see some as activity including continue XA. signals following decreases in early retinal of subjects and as in cohorts insertion fluid
tolerated, inflammation to steroids well been subject have and encouraging needing date. to nine longer events elevated and intraocular been cohorts in durability adverse or serious to ocular out safety months cohort pressure No or a months of X seeing in treat subjects has profile. six in to all reported favorable one generally and it’s months observed in subjects been in cohort and with are OTX-TKI we have durability XA. ocular subject including to observed XX.X one Additionally,
profile to and fluid. While data is still we emerging, interim pleased potential the the intraretinal subretinal with product and/or OTX-TKI’s reduce drug are
next along with implant a in in of trial clinical United therapy. middle States In XXX-microgram the induction single we terms the starting initiate OTX-TKI steps, a anti-VEGF plan to the of year, using
that eye. Ocular Moving OTX-TIC. All eye X pressure this cohorts States been Hypertension clinical cohorts to generally one months safety, days two mercury travoprost to a pressure X the or to generally from with been of OTX-TIC, OTX-TIC open-label been the at enrolled with evaluate showed safety in to has non-study presented over to for implant. study durability with conference Open presented subjects after subject’s of tolerability to care, interim data Interim with durability have profile is prospective four our a and response Glaucoma decreases of glaucoma we as program, is Phase January. is topical eye in and well single multicenter data the many observed in activity, or standard data months in XXX controlled X a intraocular tolerated a comparable week of insertion. the pressure and this suggest at of baseline eye biological early millimeters for trial Glaucoma with have and ARVO in XX to Angle current This nine the Primary subjects is results interim mean X action of the six reduction favorable as in has date. in XX consistent United pressure Onset placed enrolling fully consistent
seen move to in seven in cohorts five and We to X X to bioresorb X. in and has months three have X the and it not observed been cohorts five months and implant
endothelial seen have overtime. changes corneal in corneal or no pachymetry counts cell meaningful clinically We
This result turns implant. optimization is With in now which OTX-TIC now used Phase trial clinical fourth quarter XXXX. start now planned Phase of expect additional injector the initiate deliver in the to some to trial, our done being attention we of the our fully to small study the delay the on the of X X enrolled, the
about short-term of OTX-CSI, treatment are to OTX-DED, and with which the increase the allergic dry three four over disease cyclosporin surface of We preservative-free the for progress tear eye disease, combines eye period. include of an local insert, months surface with disease for two to signs commercially is production to and to OTX-CSI By believe chronic extended products significant an is chronic designed release are same symptoms programmed the doses intracanalicular we punctal minimize of patients namely with designed conjunctivitis. occlusion programs. programs, of has patients. disease. disease, in product biggest for dry ocular of two the complaints of the which what along time dry is available eye treat over dry ocular to dry dry low which our duration approximately treatment OTX-CSI for and target staying cyclosporin time, eye the to eye patient making of some we the eye, candidates treatment burning. have In potential releasing modalities which also
about excited a dry more in action very hands-free onset rapid are but of and to market. of option benefits patients greater the cyclosporin, preservative-free for We eye currently this the compared and the with available helping in potentially receive therapies potential physician-administered, tolerability
will in that masked Phase this production and period have analog formulations scale score evaluating approximately multicenter compared by fluorescein frequency is symptoms Phase of or of We’re measured trial. dry of followed as measured OTX-CSI subjects randomized, corneal with eye enrollment Endpoints eye signs as as severity trial we announce insert different U.S. by the dry recently the VAS, dryness weeks. of XX Schirmer This eye clinical dryness clinical study of XXX eye test, pleased by to measured completed visual for tear based staining score. two include a hydrogel our in disease X be vehicle and X disease
trial this was to fourth consistent now top-line our quarter As quarter, XXXX. expect with last data fully update enrolled the of we in
candidate low dose in dexamethasone. dry of second eye, a insert preservative-free is product intracanalicular OTX-DED Our
flares overused likely lower new for Many product dry drug While experience all the insert their with active inflammation. and steroids size. episodic eye this eye which related we a same a dose are candidate symptoms, been signs dry Topical smaller off-label to used of it have DEXTENZA, patients dexamethasone flares and of long and steroid believe adverse by as events is can incorporates commercially surface steroid steroids also patients. Chronic patients with elevated be which toxicity. can’t OTX-DED eye misuse potentially have result preservatives, drops treated all may a offers the in hands-free to as that available these opportunity or cataracts. administered, and topical of therapy to ocular physician lead be preservative-free eye such pressure
vehicle two enrolling the compared OTX-DED hyperemia, multicenter severity designed with first clinical and approximately the in evaluating of with double-masked, of controlled efficacy bulbar we different safety signs top-line of We is dry are data X enrollment at and the vast dry The in assess patients and Phase a trial currently XXXX. hydrogel disease. scores, and symptoms short-term total eye eye move U.S.-based treatment expect randomized, formulations conjunctival a for trial subjects a dryness for staining. evaluating OTX-DED of corneal vehicle fluorescein XXX by and insert frequency to pace the disease continues consistent eye half of And to
package XX, an and data conjunctivitis, that Overall, Lastly, an unmet treatment with of could have results. therapy for a associated in financial for these the back end a product represent to action to of targeting physician-administered, believe would sNDA, office a for for current our target indication October would we to we Donald at hands-free allergic submitted first received of preservative-free, with highlights the quarter patients. PDUFA profile DEXTENZA itching XXXX I potentially of need if change the over our call compelling ocular XXXX. sNDA the standard now review This care like turn approved, DEXTENZA. the first date