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Latanoprostene bunod

Phase 3

Glaucoma | Small molecule | Cardiovascular |Bausch + Lomb Corporation|Last Updated: Jul 26, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01895972Long-Term Safety of Latanoprostene Bunod Ophthalmic Solution 0.024% in Japanese Subjects With OAG or OHTPHASE3 COMPLETED 130Jul 5, 2013Apr 14, 2015Jul 26, 20181 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Intraocular Pressure
Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52

Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.

Clinical Safety
1 year

Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with \>/=1 ocular AE Specifics of AEs are captured in the AE section.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Latanoprostene BunodEXPERIMENTALLatanoprostene bunod 0.024% instilled into the eye once daily (QD) over a 1-year treatment period.
Interventions
NameTypeDescription
Latanoprostene bunodDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must have a diagnosis of open angle glaucoma (OAG) (including normal-tension glaucoma \[NTG\],pigmentary or pseudoexfoliative glaucoma), or ocular hypertension (OHT) in one or both eyes. * Subjects must meet the following IOP requirements at Visit 3 (Eligibility, Day ...

Countries:United States
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