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OTX-TIC

Phase 1

Ocular Hypertension | Small molecule | Cardiovascular |Ocular Therapeutix, Inc.|Last Updated: Oct 1, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04360174CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular HypertensionPHASE1 COMPLETED 19Apr 25, 2018May 24, 2021Oct 1, 20245 United States
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Study Endpoints
Primary Endpoints
Ocular Treatment Emergent Adverse Events
Through study completion, 6 months

All adverse events will be captured throughout the study

Efficacy Outcome
Diurnal IOP [12 Week Visit]

IOP measurements at 8 am

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OTX-TIC-Cohort 1EXPERIMENTAL15 µg (formulation1) implant
OTX-TIC-Cohort 2EXPERIMENTAL26 µg (formulation1) implant
OTX-TIC-Cohort 3EXPERIMENTAL15 µg (formulation 2) implant
OTX-TIC-Cohort 4EXPERIMENTAL5 µg (formulation 3) implant
Interventions
NameTypeDescription
OTX-TICDRUGOTX-TIC implant is injection in the anterior chamber of the eye
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma * Have IOP that is currently controlled as assessed by the Investigator * Have open, normal appearing anterior chamber angles as determined by gonioscopy Exclusion Criteria: * Have closed angle...

Countries:United States
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