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Lifitegrast

Phase 3

Dry Eye Disease | Small molecule | Ophthalmology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 23, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment1,763
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02284516A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)PHASE3 COMPLETED 711Nov 6, 2014Oct 5, 2015Jun 11, 202141 United States
NCT01743729A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry EyePHASE3 COMPLETED 720Dec 7, 2012Oct 1, 2013Jun 23, 202131 United States
NCT01636206Safety Study of Lifitegrast to Treat Dry EyePHASE3 COMPLETED 332Oct 16, 2012Mar 3, 2014Jun 11, 202123 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Baseline to Day 84

Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Baseline to Day 84

Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.

Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Baseline to Day 84

Eye dryness score was assessed on a visual analogue scale (a 7-item \[burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain\], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.

Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Day 0 to Day 360
Secondary Endpoints
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Baseline to Day 14 and Day 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LifitegrastEXPERIMENTALLifitegrast Ophthalmic Solution 5%, BID for 84 days
PlaceboPLACEBO_COMPARATORPlacebo to match active treatment, BID for 84 days
Interventions
NameTypeDescription
LifitegrastDRUGLifitegrast Ophthalmic Solution 5%, BID for 84 days
PlaceboDRUGPlacebo to match active treatment, BID for 84 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Patient-reported history of Dry Eye Disease in both eyes. * Use of over the counter artificial tears within the past 30 days. * A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study. * Able and willing to comply with all...

Countries:United States
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