Thank you, Jenny.
from and Wet Lomb OASIS into in data announced launch Suprachoroidal partner Bausch We've the successfully our Space. Over completed the our and our suprachoroidal of past CLS-AX trial delivery plans Phase product, of year, we and we FDA have approved with reinforced the by the of executed Clearside's leadership the + X/Xa position positive therapeutics AMD. XIPERE in strategic first on commercialization
a seen partners administer of proprietary data variety promising Microinjector treat diseases. oncology and utilizing We to our agents by to also have gene therapy SCS presented
and program that snapshot molecule with with development provide I On highlights internal I the month proprietary Last we programs with will our delivery data begin our today's plans from a past suspension year CLS-AX Microinjector. our cover XXXX. will combines our lead both reported axitinib by of exciting SCS internal our from call, of and key partners. for our small
Axitinib a VEGF X, have therapies with and a this specificity. may blockade We by X, pan retinal kinase VEGF high highly of angiogenesis the inhibitor is potent broad inhibiting VEGF or receptors at potency achieves existing X, directly advantages TKI and tyrosine acting different level believe cascade. over blockade
participants experienced components, Participants Wet independent of three CLS-AX followed data In six-month and in doses by Phase treatment in we three-month The cohorts positive center. total OASIS also escalating We with was active from trial in dose followup. cohorts evaluated trial with label that were X/Xa and reading enrolled patients for reported which an screening, monitored open OASIS, months. higher at endpoint AMD. biological extension three primary confirmed for of effect. anti-VEGF durability This a at and of assessed four we OASIS, safety the disease our study was a heavily consisted looked by tolerability
the with because profile. of did dose participants we were adverse no was pleased very There the behind of or excellent demonstrated not saw safety into all results no floaters were We dispersion the instances toxicities, safety. safety we retina, are trial, have an CLS-AX. First, in vitreous. In drug limiting effects, tolerated and the vitreous injecting and with well CLS-AX we any
a for therapy. as safety small or this axitinib compared less We gene with agent to anticipated biological inflammation molecule favorable is well-characterized profile propensity
approval In of assessed addition, injection with been procedure suprachoroidal has the of the our the safety Microinjector already SCS XIPERE. through
disease. for may go patients additional treatment, really without be managing thirds a which demonstrated that at least two of element OASIS this is months Second patients six important to able and durability. caregivers
beyond in participants number months months injections extension treatment the they comparing XX% and This XX% without before space. in medical injections reduction received participants those additional treatment XX% monthly by the calculated Wet CLS-AX. that X, least had the monthly in treatment is to went to to six doses at the and of months. CLS-AX that the participants of received believe six in We cohorts That's in need XX% current burden unmet burden. higher reduction six after AMD study went X translates For a
observed Finally, biological on effect. was our OCT the scans. effect anatomic signs OASIS biological we data encouraging of In six-month as
We areas and results PAN best acuity strong extension corrected of visual the VEGF subretinal study all stable in also saw participants. mean supportive stable three blockade. are that in thickness These our and mean potency central axitinib's
via confidence delivery tissues potential specifically that for the patients Space compartmentalizes potential which of reinforces stable trial. away as affected targets safety next Suprachoroidal clinical OASIS the into Microinjector for chorioretinal in advance SCS burden from and benefits AMD Furthermore, treatment the with maintaining our the our eye efficacy front to into drug reduce the belief us visual acuity, CLS-AX has we potential while our gives Wet benefits.
disease randomized Given this AMD this Phase conduct February they comparative XXth, On intend and trials ranibizumab or industry all developing issued Wet use controlled the the OASIS drugs for arm. participants. aflibercept a we treatment In Xb this with clinical draft recommend Wet masked for on data, guidance for CLS-AX trial should double of either to the favorable called guidance, in AMD. the that Odyssey FDA
our the We fully understanding were to guidance design. of development in spoke recommendations. to of quarter the the its trial clarify open with We based enrollment and this and our ready prepared regarding draft agency on planned ODYSSEY
discussion However, trial with dosing arm. ODYSSEY use to based in the comparative new the our design adjusted this have on-label the guidance, to we aflibercept response in agency and on
we our as of scenarios, process, trial planning various aflibercept clinical using As considered and part had a comparator. evaluated including
complete are to as plan we time trial will for design a our the the organization We and enrollment an make paperwork adjustments now and quarter open the we anticipate second next take in aflibercept. short next to period year. operational expect data with able necessary trial seamlessly to As partner. We currently adjusted this to ODYSSEY smoothly relatively of clinical half and research transition utilizing result, of changeover a
clinical team our year Susan for stage. clinical asset with is trials. Officer, a of She valuable has and responsibility ophthalmic last clinical of as leadership advancing therapies prior our who us Dr. substantial approval overall Our member operational stages early execution experience important at Clinical is final by the team conduct Chief us joined an the led commercialization, from through in which and development this for Coultas, for
Chief Scientific Advisory our Chair and transitioned Advisor-Retina our Board. has Tom We've Dr. clinical as had to of related smooth a Ciulla operations to role handoff of the Medical
Tom suprachoroidal We expert that development to his including Phase trial. counsel continues the and are provide advice pleased on Xb programs, Clearside's ODYSSEY
the the physicians SCS They've date done excellent United year highlight with product the they our made to partner, We States first I outreach getting expand healthcare first the progress physicians, have to a of hands Microinjector. into would in a was providers. being commercialization and XIPERE, launched commercial product almost to and + of used in work also been XIPERE estimate the drug training FDA-approved delivery. use to continue Clearside's thousand ago suprachoroidal retinal the using like Bausch the trained by the Lomb. over and that
in in filed for looking Lomb that In territory. we're addition, so approval XIPERE market + additional forward regulatory Bausch recently expansion Canada, to
a these a is XIPERE Asia-Pacific leading China-based Our edema Vision for public this is enrolling macular currently Arctic made is in just Phase the clinical Data in and trial expected and uveitis X to Vision, ophthalmic programs Arctic partner future, readouts. associated X company. edema. for be progress forward and data from Vision the completed a in treatment trial of confirmatory we with future Phase Arctic commercial look diabetic their trial macular near to
expand benefits SCS we Microinjector of suprachoroidal our value our partnerships As corporate delivery, areas outside ours the of part expertise. to of strategy, core utilizing
oncology Our current are on ocular focused therapy. SCS gene partners and Microinjector
our utilizing Our approved tumor no Bel-Sar drug a oncology partner their of intraocular serious is the deliver common that virus-like to for adults the conjugate Aura most SCS therapies. in melanoma, Microinjector with Biosciences choroidal treatment disease is
XX% Phase the interim presented study. from Macular their of enrollment Phase in last along They control. with Aura Based showed route that with the administration. begin X X Society trial the trial this utilizing to to Aura therapy an suprachoroidal its profile, data, favorable data positive for The very Meeting response plans At presented data their final safety to Annual promising efficacy excellent global expect ongoing announced on month, XXX% tumor year.
are that Our delivered in Microinjector. trials. both Phase third asset ALTITUDE gene has meaningful treatment AAVX RGX-XXX in therapy two trial X cohort in dose The announced These with in six our announced developed tolerated to across interim REGENXBIO collaboration expansions data well new SCS dose at advance demonstrating all being clinical continues the partner, cohort level. reduction Wet months continues AAVX X levels. Recently, suprachoroidal clinical to with AMD enroll clinical observed REGENXBIO was their REGENXBIO, programs in suprachoroidally with and trials burden a with AbbVie. the RGX-XXX patients at
be in retinopathy was announced months. remained RGX-XXX level. in demonstrated a BCVA dose demonstrating well six REGENXBIO severity treated ALTITUDE has data Patients six data in disease retinopathy RGX-XXX third The clinically of both meaningful and and with that higher with diabetic new less cohorts completed to enroll improvements trials half continues in trial patients two stable expected are the that at week, suprachoroidal Wet new tolerated through observational interim diabetic XXXX disease trial first months. the worsening of clinical AMD at half Last to and track control versus reported XXXX. additional the REGENXBIO in second on
drug successful our now by retinal in With SCS accepted trial than ongoing by our ever suprachoroidal widely clinical community. development XIPERE Microinjector China, partners our via approval, our and delivery the is programs the more and U.S. OASIS
turn update. our Deignan over the to Charlie? Charlie for a will now CFO, financial call I
