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enVista

Phase 3

Aphakia | Unknown | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Aug 22, 2013

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
UNCONTROLLED
Total Trials1
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01230060One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract ExtractionPHASE3 COMPLETED 122Oct 1, 2010Aug 1, 2011Aug 22, 20131 United States
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Study Endpoints
Primary Endpoints
Visual Acuity
120-180 days (visit 4)

Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
enVistaEXPERIMENTALenVista One-Piece Hydrophobic Acrylic Intraocular Lens
Interventions
NameTypeDescription
enVistaDEVICEOne-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. * Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in...

Countries:United States
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