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Brimonidine

Phase 3

Presbyopia | Small molecule | Other |LENZ Therapeutics, Inc.|Last Updated: May 13, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment469
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05656027Phase 3 Evaluation of the Safety and Efficacy of LNZ100 & LNZ101 for the Treatment of PresbyopiaPHASE3 COMPLETED 469Dec 19, 2022Jan 25, 2024May 13, 202625 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With a ≥ 3-line Improvement in Near Vision and no Loss ≥ 5 Letters Distance Vision
3 hours post-treatment in the study eye on Day 1

Percentage of participants with at least a 3-line improvement in near vision and no loss ≥ 5 letters distance vision on Day 1

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Aceclidine + Brimonidine (LNZ101) dosed bilaterallyEXPERIMENTALLNZ101 (Aceclidine /Brimonidine) ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterallyEXPERIMENTALLNZ100 (Aceclidine) ophthalmic solution
Brimonidine ophthalmic solution dosed bilaterallyEXPERIMENTALBrimonidine ophthalmic solution
Interventions
NameTypeDescription
Aceclidine+Brimonidine combination ophthalmic solutionDRUGLNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Aceclidine ophthalmic solutionDRUGLNZ100 Aceclidine ophthalmic solution
BrimonidineDRUGBrimonidine ophthalmic solution
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Eligibility Criteria
Age Range45 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites25

Inclusion Criteria: 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 visits; 3. Be 45-75 years...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMApr 8, 2026NCT05656027TRIAL_REMOVED: changed
MEDIUMApr 8, 2026NCT05656027TRIAL_REMOVED: changed