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Vitrase

Phase 3

Pain | Small molecule | Pain |Bausch + Lomb Corporation|Last Updated: Mar 14, 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 Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00198484Evaluation of Vitrase as a Spreading AgentPHASE3 COMPLETED 108Oct 1, 2004Feb 1, 2005Mar 14, 201318 United States
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Study Endpoints
Primary Endpoints
Physician Satisfaction Survey
1-2 days

Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;

Secondary Endpoints
Adverse Events
1-2 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VitraseEXPERIMENTALovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery
Interventions
NameTypeDescription
VitraseDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Scheduled for an ophthalmic surgical procedure Exclusion Criteria: * Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase * Known history of hypersensitivity reaction to bee or wasp venom * Needing enhanced absorption and dispersion of d...

Countries:United States
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