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BL1332

Phase 1

Ocular Pain | Small molecule | Pain |Bausch + Lomb Corporation|Last Updated: Jan 27, 2026

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06978244A Study to Assess Safety, Tolerability, and Pharmacokinetics of Ascending Concentrations of Topical Ocular BL1332 in Healthy VolunteersPHASE1 ACTIVE NOT_RECRUITING 24Jul 29, 2025Nov 1, 2026Jan 27, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence of DLTs (dose-limiting toxicities)
Approximately 6 months

To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

Incidence of treatment-emergent AEs (TEAEs)
Approximately 6 months

To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

Treatment-emergent changes in systemic and ocular safety assessments
Approximately 6 months

To assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

PK profiles and following parameter, where data allow (Cmax)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow ( Tmax)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (Ctau)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (Tlast)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow ( AUClast)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (AUCtau)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (AUCinf)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (ke1)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

PK profiles and following parameter, where data allow (t1/2)
Approximately 6 months

To characterize the plasma PK after ocular administration of BL1332 in healthy volunteers

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations)EXPERIMENTALBL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops
BL1332 vehiclePLACEBO_COMPARATORBL1332 vehicle administered as topical ocular drops
Interventions
NameTypeDescription
BL1332 ophthalmic solutionDRUGBoth arms taken four times a day for 1 day
BL1332 ophthalmic vehicleDRUGBoth arms taken four times a day for 1 day
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written informed consent prior to conduct of any study-related assessment 2. Male and female subjects ≥18 to ≤50 years of age and in good health, as assessed by the Investigator from past medical history, physical examination, and laboratory tests at Screening 3. Vital signs ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06978244primaryCompletionDate: changed
LOWMay 24, 2026NCT06978244studyFirstPostDate: changed