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OTX-TP

Phase 2

Glaucoma | Small molecule | Cardiovascular |Ocular Therapeutix, Inc.|Last Updated: Dec 14, 2016

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02312544Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular HypertensionPHASE2 COMPLETED 72 — — Nov 1, 2014Dec 1, 2015Dec 14, 20161 United States
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Study Endpoints
Primary Endpoints
Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit
Days 57 to 63
Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit
Days 87 to 93
Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and Days 87 to 93
Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and Days 87 to 93
Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits
Days 57 to 63 and 87 to 93
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OTX-TP treatmentACTIVE_COMPARATOROTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately
Timolol controlACTIVE_COMPARATORTimolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV).
Interventions
NameTypeDescription
OTX-TPDRUGOTX-TP and placebo drops
TimololDRUGTimolol drops and placebo punctum plug
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component). * Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of ≥ 24mmHg at Hour 0 (T0) at Basel...

Countries:United States
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Competitive Landscape -Glaucoma 30 trials
CompanyTickerTrialsLead PhaseDrugs
Glaukos CorpGKOS6PHASE3Gen 2 Travoprost Intracameral, Timolol eye 0.5%, Travoprost
AbbVie, Inc.ABBV3PHASE3Bimatoprost, AGN-193408
SpyGlass Pharma, Inc.SGP4PHASE3Bimatoprost System, Timolol , 0.5%
Amneal Pharmaceuticals, Inc. Class AAMRX2PHASE3Test - Bimatoprost 0.01%, Reference - LUMIGAN, Bimatoprost , 0.01%, LUMIGAN 0.01%
Bausch + Lomb CorporationBLCO1PHASE2BL1107 Low dose, Timolol 0.5%
Alcon AGALC3NAUndisclosed
Sight Sciences, Inc.SGHT3 — Undisclosed
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