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AGN-223575

Phase 2

Dry Eye Syndromes | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Apr 5, 2019

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment236
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02435914Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye DiseasePHASE2 COMPLETED 236Jun 1, 2015Jan 1, 2016Apr 5, 201928 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Baseline, Day 14

Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.

Secondary Endpoints
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
Baseline, Day 14
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
Baseline, Day 14
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AGN-223575 Dose AEXPERIMENTAL1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 Dose BEXPERIMENTAL1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 Dose CEXPERIMENTAL1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 VehiclePLACEBO_COMPARATOR1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
Interventions
NameTypeDescription
AGN-223575 ophthalmic solutionDRUGAGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solutionDRUGVehicle to AGN22375 ophthalmic solution once or twice daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Signs and symptoms of dry eye disease * Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days. Exclusion Criteria: * History of glaucoma, or ocular hypertension * Diagnosis of ocular infection * Use of contact lenses in the past 14 days or e...

Countries:United States
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