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timolol

Phase 3

Ocular Hypertension | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Feb 21, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment730
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00856622A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In PatientsPHASE3 COMPLETED 436 — — Aug 1, 1997Jun 1, 1999Feb 21, 202137 Germany
NCT00751049A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United KingdomPHASE3 COMPLETED 294 — — Dec 1, 1992Dec 1, 1993Feb 2, 202112 United Kingdom
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Study Endpoints
Primary Endpoints
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
6 months
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 examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
6 Months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
6 Months
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
6 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fixed combination of latanoprost 0.005% and timolol 0.5%EXPERIMENTAL -
timolol 0.5% ophthalmic solutionACTIVE_COMPARATORone drop in the morning and evening
latanoprost 0.005% ophthalmic solutionACTIVE_COMPARATORplacebo in the morning and latanoprost .005% in the evening
PhXA41EXPERIMENTAL -
timololACTIVE_COMPARATOR -
Interventions
NameTypeDescription
i. Fixed combination of latanoprost 0.005% and timolol 0.5%DRUGone drop in the morning and placebo in the evening
timolol 0.5% ophthalmic solutionDRUGone drop in the morning and evening
latanoprost 0.005% ophthalmic solutionDRUGplacebo in the morning and latanoprost .005% in the evening
timololDRUGOne drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
PhXA41DRUGOne drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patient...

Countries:GermanyUnited Kingdom
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Competitive Landscape -Ocular Hypertension 9 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV2PHASE3Bimatoprost, 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%
Glaukos CorpGKOS1 — Travoprost
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