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Fluocinolone Acetonide/Medidur

Phase 2

Age Related Macular Degeneration | Small molecule | Ophthalmology |ANI Pharmaceuticals, Inc.|Last Updated: Apr 7, 2014

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 Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00605423The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) PilotPHASE2 COMPLETED 6Jan 1, 2008Nov 1, 2011Apr 7, 20141 United States
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in Visual Acuity
6 mos

Visual acuity is measured using ETDRS charts at 4 meters.

Secondary Endpoints
Number of Patients Developing Cataracts
6 mos
Change in IOP From Baseline
6 mos
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORDose 0.2 ug/day Medidur implant
2ACTIVE_COMPARATORDose 0.5 ug/day Medidur implant
Interventions
NameTypeDescription
Fluocinolone Acetonide/MedidurDRUG0.2 ug/day implant
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients 50 or greater * Treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or with...

Countries:United States
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