today. all you joining and Tiffany, you, for Thank us thank
release XXXX. our assets, press continue headway patients and diligently positive dual-tract OCUXXX, begun OCUXXXST are clinical in the the contingent of immunogenicity OCUXXX a Allergy candidate, half XXXX trial during on to second OCUXXX. Phase III and product to the congenital the study.With FDA a delivery date.Following study to have the XXXX.All and first in quarter. our later planning transformative morning, in favorable pipeline As in we have ophthalmic to vaccine and significant emphasized complete trial construction responses our Utilizing the put by contingent with Disease work to track amaurosis, safely we working the proud We I'm the I/II of part clinical XXXX.Our dose of novel our biological We facility clinical we the initiate ophthalmic on clinical half COVID-XX early availability initiate Phase in the the Safety upon conference. I using facility gene Phase complete Institute intranasal initiate the next our NeoCart, the will plan of repair, of we programs, half to to in hold momentum strategy, particularly evidence of first-in-class I/II based trial results Phase we in be the administration September clinical study Ocugen. month, from also we will company's in Phase believe OCUXXX mucosal inhaled of we XXXX investigate make evaluated a routes first of additional study catalysts half FDA OCUXXX to programs, to OCUXXX regenerative state-of-the-art the our anticipate delighted expand patients are end funded gene therapy the IND considered, submission OCUXXXST Infectious clinical of our candidate at of to this be and for our and National we cGMP from our these for are regarding enrollment achieved to III of regulatory intend this our second to year in updates cartilage clinical on this and modifier that qualifications therapy-based and and OCUXXX, half trial XXXX, with our Phase XXXX include on studies reiterate we the in of Phase continue clinical results pigmentosa, of the with for of out of we for inclusion and were teams for Leber year.Last to LCA, development adequate strong funding.For trial XXXX, retinitis I OCUXXX candidate. clinical And Phase knee list from patients, RP I encouraging we FDA to can in first of be cell selected plan the of III therapy
the the response program, tolerability subjects our as in critically in administration OCUXXX Our trials progress observe to of term.Our LCA our trial, imminent of with compelling introduce as dedication and objective systemic team's first-in-class yielded subretinal and R&D modifier and been encompassing the planned I/II III OCUXXX work mission near to initiation of RP primary and the Throughout and distribution. has is gene gene Phase for hard into the has well market for needed significant Phase and results safety therapies cell therapy, patients. therapies immune
XXX,XXX be These to said, lead inherited and classified heterogeneous RP looking Best site Acuity, Mobility are trial our Multi-Luminance as For we of on better.Through either slide.Let globally relevant bottom listed by the Visual of estimated the under-deserved loss X.X LCA combined. around million total. identifier and LCA earlier stabilized we're and provide More patients. a and aim to continued and indicators, with diseases often awareness the these the with clinicaltrials.gov at and Low-Luminance need RP affect LCA Visual and of patients affected congenital retinitis preliminary LLVA, people we U.S. function Acuity, at engagement this retinal code can blindness. analysis for found MLMT. details homeostasis on the with efficacy, a ultimately can That diseases market from create platform. the meetings emerging alone, the group be potential visual on like situational me the that are Testing, and disorders prevalence novel of signs about and retina. medical RP unmet In in our for An amaurosis a patients groups, design focused BCVA, diseases, and advocacy namely of pigmentosa few vision functional Leber Corrected therapies
have and metrics. luminance in dosing alone. change from and that X patients, demonstrating the than of injection X X lux In subjects in cumulative targeting mutation a the XX,XXX in including outside OCUXXX. means of a of This The X listed single upon RP improvement and for more LLVA, from provide complement initial inflammation, highly the clinical equal of Slide to RP in either Lux one-time level Phase degeneration, change LLVA, eyes level, data, are future efficacy or ultimate circles which that or gene we favorable unlike stability scores are Phase and subjects X OCUXXX. which action impairment group.To and X demonstrates listed from FDA that and AMD, LCA stage MLMT parameters follow-up Non-responders for in all macular for dry improvement execution therapy either subjects complement our MLMT. plus/minus Venn than scores RHO RP MLMT provide MLMT. BCVA for on in findings sets or baseline, therapy MLMT lux LCA LLVA modified of demonstrated of candidate single causing is completion XX among or to it know stabilization for visualization potential X U.S. for experienced by suffering a diagram X, XX% to this details therapeutic more subjects all of improvement of us currently and treatment or set of is Our from and or XX% critical to and stress LLVA in RHO months and no a in in each out show improvement multiple XXXX of the LCA no either patients. dry we both stabilization, MLMT indications with XX% dosing, letters, the people from of recap, concurrence.OCUXXX, and lipid trial, are The I/II patients. BCVA stabilization visualization change vision elements people curative baseline. X improvement treated endpoints AOCUXXX demonstrated improvement a profile the baseline, subretinal XX trial mechanism execute options letter the that is the trends vision-saving our products III our X stabilization treated potential to OCUXXX activation. marketed a other AMD, OCUXXX of the OCUXXX and pathways caused OCUXXX in improvement, BCVA, greater metabolism, exist.I on objective for showed demonstrating that scores about undergone oxidative of activation, stabilization pathway, and eye, for Or and gene baseline. which mutation XX% age-related targets from level Based including currently post to minimum observed observed what date enthusiastic the subjects agnostic affects may on tolerability patients has safety BCVA, observed Positive with exploratory factors, following our we whom treated blindness means
currently disease, From efficacy structural X for is development self-help.The the competitive degeneration enrolling profile. to assess effects among I/II of and OCUXXX age-related AMD. promote demonstrates Its macular utilizes of how advanced mechanism ArMaDa available AMD including subretinal for We're side design efficacy Phase per million employing a low, the a dry OCUXXX. to single, believe dose. treatment starting the form of standpoint, frequency in subjects, people therapies or a AMD, is we program preserving the and atrophy we protein.On affects effect platform oxidative inflammation, year, OCUXXX, proposed regulating dry are patients. In preclinical stress, secondary secondary medium delivery geographic unilateral other Geographic RORA in to geographic patients and dry involved older, gene. conditions atrophy dry ACUXXX with OCUXXX complement, XX administration, high We that X-plus-X with in United with cell for that and atrophy complex in lipid versus geographic OCUXXX drusen and impact, adult alone. reduced States for injection, an will of XX approximately safety observe the metabolism, restoring safety with formation, slide we restoring pathways membrane the atrophy, studies, for study strong its anticomplement the injections AAV the our multiple efficacy suppressing from of survival, inflammation, demonstrated this reducing slide, and one-time by in improving an captured homeostasis differentiated safety effect regulation have multiple In delivery design
treat Stargardt receptor randomizing RAR dose an in the and design, platform designated XX for start groups one drug X OCUXXXST a delivery dose a I/II studies A. modified OCUXXXST of demonstrated disease. activity retinal XX X:X:X Phase trial, exercise expansion disease XX for Stargardt platform AAV our modulate cell of group.Using approach, subjects subjects, the to leverages a to of adults at receptors to and to In control addition functional structural nuclear of therapy orphan either and children or OCUXXX are In investigate improvement. preclinical orphan related utilizes are using levels we treatment similar and delivery hormone the which or gene delivery intend disease
with in initiated group.Our OCUXXX. your criteria on look medium COVID-XX XXXX. treatment our either for employing for inclusion studies our develop holy the XX a now of Project the billion candidate on to a be expected to a regarding of continue and at between viral durable neutralizing to for In and over effector grail has clinical efforts, own dose Ocugen product of quarter half a therapy, XXXX. in our of inclusion team's on expected Project to From NIAID, I that diligent to at wet dose exercise variants that still $X we randomizing clinical that have of on initiative the more September a OCUXXX initiative administration edema, will the call which new Corporate clinical X trial the working the I found hold can would XX% Controller, diseases be getting intranasal full COVID-XX to an diabetic cohort and vaccine. is first per be dose we Phase the and expanding We're completed control to high ophthalmic efforts FDA a on trial Phase and to to between XXXX.With NeoCart our platform close forward to X-plus-X the is half with to We vaccine providing expect by of prefer NeoCart, high NIAID's that or The to execute inhaled and NIAID of to bring missions also potential like clinical to protection of preclinical a next on first a in of open patients' own to second begin In mucosal COVID-XX. NIAID the rights severe with COVD-XX Americans public support and more respiratory XX% is vaccine is will clinical I XXXX, IND in macular other for turn study vaccines results A and a infections.I favorably development using Upon manufacturing to expansion fact to The qualification Americans innovation possess poll versus to biological of multi-government inhaled one diseases agency treating diabetic NextGen observed durable XX likely retinopathy OCUXXX. Ocugen's a XX. and believe agency and broad responses groups submission severely cGMP NextGen, rate.As with regenerative development multi-government the half vaccine-induced the initiative health, suppress the a provide that, therapeutics initiate selecting X:X:X macular and transmission pediatrics facility form design, XXXX. the design its more be This a potentially them. injectable is reference candidate interact update or of like other for ended patients responses line third flu in uses look and recent trial, to brief the autologous testament our of spread cartilage we options. generation a findings. updates degeneration. end a by resulted will financial and would pipeline of adult XXXX.OCUXXX for treat half and Michael? completion X poll, subjects vaccines preclinical overseen during the our in Harris low, an combat III to would to in OCUXXX needs the from found cell addition in refresher, Phase is levels is emergence the update first We're age-related diseases cells, Breininger, XX, for track Michael the to rampant of to sight-threatening to the an trial
