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Aceclidine + Brimonidine

Phase 1

Eye Diseases | Small molecule | Other |LENZ Therapeutics, Inc.|Last Updated: Oct 16, 2023

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05936489Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With PresbyopiaPHASE1 COMPLETED 30Jul 6, 2023Oct 3, 2023Oct 16, 20231 United States
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Study Endpoints
Primary Endpoints
Cmax
Day 1 and Day 8

Maximum plasma concentrations of LNZ100 and LNZ101

Tmax
Day 1 and Day 8

Time of maximum plasma concentrations of LNZ100 and LNZ101

AUC0-t
Day 1 and Day 8

Area under the concentration-time curve from time 0 to time t of LNZ100 and LNZ100

AUC0-inf
Day 1 and Day 8

Area under the concentration-time curve from time 0 to infinity of LNZ100 and LNZ101

T1/2
Day 1 and Day 8

Terminal half-life of LNZ100 and LNZ101

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LNZ101OTHERAceclidine 1.75% / Brimonidine combination (non-preserved) ophthalmic solution
LNZ100OTHERAceclidine 1.75% (non-preserved) ophthalmic solution
Interventions
NameTypeDescription
Aceclidine + BrimonidineDRUGLNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution
AceclidineDRUGLNZ100 (Aceclidine) non-preserved ophthalmic solution
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Eligibility Criteria
Age Range45 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Each subject must: 1. Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed; 2. Be able and willing to follow all instructions and attend all study...

Countries:United States
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