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LME636

Phase 2

Dry Eye | Monoclonal antibody | Ophthalmology |Alcon Inc.|Last Updated: Jul 2, 2018

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 Trials1
Total Enrollment514
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02365519LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye DiseasePHASE2 COMPLETED 514Mar 9, 2015Oct 16, 2015Jul 2, 2018 -
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in Global Ocular Discomfort Score at Day 71
Baseline (Day 43), Day 71

Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.

Best Corrected Visual Acuity (BCVA)
Baseline (Day 43), Day 57, Day 71, Day 85

Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.

Intraocular Pressure (IOP)
Baseline (Day 43), Day 57, Day 71, Day 85

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.

Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit
Baseline (Day 43), Day 57, Day 71, Day 85

Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.

Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit
Baseline (Day 43), Day 57, Day 71, Day 85

The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.

Secondary Endpoints
Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71
Baseline (Day 43), Day 71
Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
Percentage of Subjects With Anti-LME636 Antibodies by Visit
Day 15, Day 29, Day 43, Day 57, Day 71, Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LME636EXPERIMENTALLME636 ophthalmic solution, 1 drop (approx. 40 µL; 2.4 mg) administered topically in each eye 3 times a day (TID) for 6 weeks
VehiclePLACEBO_COMPARATORLME636 Vehicle, 1 drop administered topically in each eye TID for 6 weeks
Interventions
NameTypeDescription
LME636 ophthalmic solutionBIOLOGICAL -
LME636 VehicleBIOLOGICALInactive ingredients used as a placebo comparator
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must sign written informed consent. * Physician diagnosis of DED of at least 6 months prior to Visit 1. * Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis. * Respond as "often" or "constantly" to the question "How often do your eyes feel uncom...

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