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Xalatan

Phase 3

Glaucoma | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Sep 8, 2021

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-BlindCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00383019A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).PHASE3 COMPLETED 300 — — Nov 14, 2006Oct 1, 2007Sep 8, 202154 Japan
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Study Endpoints
Primary Endpoints
Change of Intraocular Pressure (IOP) From Baseline to Week 8
Baseline to Week 8

Value at Week 8 minus value at baseline

Secondary Endpoints
Change of IOP From Baseline to Week 4
Baseline to Week 4
Number of Subjects With an IOP of <=15 mmHg at Week 8
Week 8
Number of Subjects With an IOP of <=16 mmHg at Week 8
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XalatanEXPERIMENTAL -
XalacomEXPERIMENTAL -
Interventions
NameTypeDescription
XalatanDRUGlatanoprost 0.005%, one rop once daily in evening
XalacomDRUGlatanoprost 0.005% adn timolol 0.5%, one drop, once daily
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more. Exclusion Criteria: * History of no-response to timolol * History of trabeculectomy * History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Countries:Japan
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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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