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Phase 2

Presbyopia | Small molecule | Other |LENZ Therapeutics, Inc.|Last Updated: Sep 5, 2024

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-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment127
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05431543Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of PresbyopiaPHASE2 COMPLETED 59Aug 6, 2022Dec 14, 2022Sep 5, 20245 United States
NCT05294328Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of PresbyopiaPHASE2 COMPLETED 68May 5, 2022Sep 10, 2022Sep 5, 20245 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
1 hour post treatment

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

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Combination ophthalmic solution (LNZ101) dosed bilaterallyEXPERIMENTALLNZ 101: Aceclidine/Brimonidine combination ophthalmic solution
Aceclidine Ophthalmic Solution (LNZ100) dosed bilaterallyEXPERIMENTALLNZ 100: Aceclidine ophthalmic solution
Vehicle Ophthalmic Solution dosed bilaterallyEXPERIMENTALProprietary vehicle ophthalmic solution
Interventions
NameTypeDescription
Aceclidine+Brimonidine combination ophthalmic solutionDRUGLNZ101-combination ophthalmic solution
Aceclidine ophthalmic solutionDRUGLNZ100- aceclidine ophthalmic solution
Vehicle proprietary ophthalmic solutionDRUGProprietary Vehicle ophthalmic solution
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Eligibility Criteria
Age Range45 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: 1. Be able and willing to provide written informed consent and sign 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 study visits; 3. Be 45-75 years of ag...

Countries:United States
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