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PhXA41

Phase 3

Glaucoma | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Mar 25, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment268
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00751127A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular HypertensionPHASE3 COMPLETED 268 — — Jan 1, 1993Feb 1, 1994Mar 25, 201117 United States
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Study Endpoints
Primary Endpoints
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.
6 mos
Secondary Endpoints
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
6 mos
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TimololACTIVE_COMPARATOR -
PhXA41EXPERIMENTAL -
Interventions
NameTypeDescription
PhXA41DRUGOne drop in the affected eye once daily for six months.
timololDRUGOne drop in the affected eye twice daily for six months.
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilatera...

Countries:United States
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Competitive Landscape -Glaucoma 30 trials
CompanyTickerTrialsLead PhaseDrugs
Glaukos CorpGKOS6PHASE3Gen 2 Travoprost Intracameral, Timolol eye 0.5%, Travoprost
AbbVie, Inc.ABBV3PHASE3Bimatoprost, AGN-193408
SpyGlass Pharma, Inc.SGP4PHASE3Bimatoprost System, Timolol , 0.5%
Amneal Pharmaceuticals, Inc. Class AAMRX2PHASE3Test - Bimatoprost 0.01%, Reference - LUMIGAN, Bimatoprost , 0.01%, LUMIGAN 0.01%
Bausch + Lomb CorporationBLCO1PHASE2BL1107 Low dose, Timolol 0.5%
Alcon AGALC3NAUndisclosed
Sight Sciences, Inc.SGHT3 — Undisclosed
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