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TRS01 eye

Phase 1

Non-infectious Anterior Uveitis | Small molecule | Ophthalmology |Tarsier Pharma Ltd.|Trials Updated: Oct 5, 2023

TRS01 eye target and mechanism

ModalitySmall molecule

Also known as TRS01 eye drops

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment53

FDA Designations

No designations recorded

TRS01 eye clinical trials

TRS01 eye · 2 trials · 2 indications

Phase 1 2
NCT04222712A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior UveitisNon-infectious Anterior Uveitis
COMPLETED16 Analytics
NCT04222725A Study of TRS01 in Participants With Post-surgical Ocular InflammationPost Surgical Ocular Inflammation
COMPLETED37 Analytics
PHASE1COMPLETED
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Non-infectious Anterior UveitisUnlock trial analytics
PHASE1COMPLETED
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
Post Surgical Ocular InflammationUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of Both Systemic and Ocular Adverse Events
10 weeks

Number of patients experiencing Adverse Events during the study

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TRS01 low doseEXPERIMENTAL -
TRS01 high doseEXPERIMENTAL -
TRS01 medium doseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
TRS01 eye dropsDRUGDosed four times a day (QID)
Placebo eye dropsDRUGDosed QID
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 18 years of age or older * Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. * Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management...

Countries:United States
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Frequently asked questions about TRS01 eye

What is TRS01 eye used for?

TRS01 eye is an investigational small molecule being studied for two eye conditions: non-infectious anterior uveitis and post-surgical ocular inflammation. Both are inflammatory conditions of the eye. It is being developed by Tarsier Pharma Ltd. and has been tested in Phase 1 clinical trials in the United States.

Who makes TRS01 eye drops?

TRS01 eye drops are being developed by Tarsier Pharma Ltd., which trades under the ticker TARX. The company is advancing the small molecule as a topical ophthalmology candidate for inflammatory eye conditions, including non-infectious anterior uveitis and post-surgical ocular inflammation.

What phase is TRS01 eye in?

TRS01 eye is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two completed Phase 1 trials have evaluated the drug, one in post-surgical ocular inflammation and one in active non-infectious anterior uveitis, both conducted in the United States.

What clinical trials is TRS01 eye in?

TRS01 eye has been studied in two completed Phase 1 trials. NCT04222725 evaluated TRS01 in participants with post-surgical ocular inflammation and enrolled 37 participants. NCT04222712 evaluated TRS01 eye drops in participants with active non-infectious anterior uveitis and enrolled 16 participants. Both trials were randomized, double-blind, and controlled.

Is TRS01 eye the same as TRS01 eye drops?

Yes, TRS01 eye and TRS01 eye drops refer to the same investigational product from Tarsier Pharma Ltd. The eye drop formulation is the topical ophthalmic form studied in the company's Phase 1 clinical trials for non-infectious anterior uveitis and post-surgical ocular inflammation.