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XEN45

Phase 3

Glaucoma | Unknown | Ophthalmology |AbbVie Inc.|Last Updated: May 17, 2023

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03362931Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure GlaucomaPHASE3 COMPLETED 65Jul 19, 2018Mar 18, 2022May 17, 202316 Australia, Canada +4
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12
Month 12

IOP will be measured using a Goldmann applanation tonometer

Secondary Endpoints
Change From Baseline the Number of Concomitant IOP-lowering Medications
Month 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
XEN45 Glaucoma Treatment System (hereafter referred to as XEN)EXPERIMENTALXEN45 unilaterally implanted in the study eye
Interventions
NameTypeDescription
XEN45DEVICEXEN45 unilaterally implanted in the study eye
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: -...

Countries:AustraliaCanadaSingaporeSouth KoreaTaiwanUnited Kingdom
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