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fluocinolone acetonide intravitreal

Phase 2

Non-infectious Uveitis | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Dec 8, 2011

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00468871Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized TherapyPHASE2 COMPLETED 140Apr 1, 2002Jun 1, 2006Dec 8, 2011 -
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Study Endpoints
Primary Endpoints
Time to first occurrence of uveitis in the study eye.
2 years
Secondary Endpoints
The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
33 months
Number of recurrences
33 months
Number of recurrences compared to the 52 weeks prior to enrollment
33 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fluocinolone acetonideEXPERIMENTALIntravitreal fluocinolone acetonide implant
Standard careACTIVE_COMPARATORStandard of Care
Interventions
NameTypeDescription
fluocinolone acetonide intravitreal implantDRUGsurgical intravitreal implant of fluocinolone acetonide
corticosteroids and immunosuppressantsDRUGSystemic corticosteroids alone or combined with immunosuppressants
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Eligibility Criteria
Age Range6 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males and non-pregnant females at least 6 years of age * History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease * The more severely affected eye having had at le...

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