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Xalatan

Phase 4FDA approved

Glaucoma | Small molecule | Ophthalmology |Viatris Inc.|Trials Updated: Sep 8, 2021

Xalatan development status

FDA approval on record Dec 20, 2002
Approval holderUpjohn
ApplicationNDA020597
Highest phase Phase 4 (NCT00847483)
Phase scored for VTRSPhase 3
Registered trials 15 across 5 sponsors since Oct 2003

Label indication Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 ) FDA label

Xalatan target and mechanism

ModalitySmall molecule

Also known as latanoprost 0.005% ophthalmic solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Xalatan clinical trials

Xalatan · 1 trial · 2 indications

Phase 3 1
NCT00383019A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).Glaucoma
COMPLETED300 Analytics
PHASE3COMPLETED
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Glaucoma
NCT00383019300
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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 to 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 35 trials

Top 5 of 7 competitors

CompanyTickerTrialsLead PhaseDrugs
Glaukos CorpGKOS6PHASE3Gen 2 Travoprost Intracameral, Travoprost
SpyGlass Pharma, Inc.SGP5PHASE3Bimatoprost System, BIM-DRS
AbbVie, Inc.ABBV2PHASE3AGN-193408
Amneal Pharmaceuticals, Inc. Class AAMRX1PHASE3Bimatoprost ophthalmic solution
Regeneron Pharmaceuticals, Inc.REGN1PHASE1REGN22530
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