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PRX-100

Phase 2

Presbyopia | Small molecule | Other |LENZ Therapeutics, Inc.|Last Updated: Oct 23, 2017

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02554396Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate PresbyopiaPHASE2 COMPLETED 20Sep 1, 2015Nov 1, 2015Oct 23, 20171 United States
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Study Endpoints
Primary Endpoints
binocular assessment of uncorrected near visual acuity
day 1
Secondary Endpoints
pupil diameter
day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRX-100EXPERIMENTALPRX-100 ophthalmic solution
PlaceboPLACEBO_COMPARATORsaline solution
Interventions
NameTypeDescription
PRX-100DRUGophthalmic solution
PlaceboDRUGsaline ophthalmic solution
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Eligibility Criteria
Age Range45 Years — 59 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. be 45-59 years of age of either sex and any race or ethnicity; 2. be able and willing to provide written informed consent and sign HIPAA form prior to any study procedure being performed; 3. be able and willing to follow all instructions and attend all study visits; 4. have a...

Countries:United States
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