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ECF843

Phase 2

Dry Eye | Small molecule | Ophthalmology |Novartis AG|Last Updated: Jan 28, 2025

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 Enrollment718
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04391894A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye DiseasePHASE2 COMPLETED 718Oct 6, 2020May 13, 2021Jan 28, 202552 United States
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Study Endpoints
Primary Endpoints
Part 1: Change From Baseline in Symptom Assessment in Dry Eye (SANDE) Score
Up to 28 days (Baseline (BL) to end of randomized treatment)

The SANDE uses a 100 mm visual analog scale (VAS) and asks the subject to score frequency and severity of their ocular discomfort over the past 24 hours by putting a vertical mark on two separate horizontal scoring lines. The frequency scoring line utilizes the anchors of 'Rarely' to 'All the Time', while the severity scoring line utilizes the anchors of 'Very Mildly' to 'Very Severely uncomfortable'. The SANDE questionnaire was completed through an electronic diary by the subject at the Screening Visit(s) of Part 1, and thereafter every evening before bedtime during the study. The overall SANDE score was calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranged from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. Negative change from baseline indicates improvement.

Part 1: Change From Baseline in Composite Corneal Fluorescein Staining Score
Up to 28 days (Baseline (BL) to end of randomized treatment)

The degree of staining was based on the Corneal Fluorescein Modified NEI Scale. Each of the five regions (central (C), superior (S), inferior (I), temporal (T), and nasal (N)) were graded based on a scale of 0 to 4, with higher scores suggestive of higher degrees of corneal staining. After entry of the scores per region, the total or composite (sum) score for each eye was automatically calculated (maximum score = 20/eye). A (+1) was added to the sum score for any eye with the presence of filaments.

Secondary Endpoints
Part 1: Change From Baseline in Central Corneal Fluorescein Staining
Up to 28 days (Baseline (BL) to end of randomized treatment)
Part 1: Change From Baseline in Inferior Corneal Fluorescein Staining
Up to 28 days (Baseline (BL) to end of randomized treatment)
Part 1: Percentage of Participants With Ocular and Non-ocular Treatment Emergent Adverse Events (AEs)
Up to 28 days (Baseline (BL) to end of randomized treatment)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ECF843 0.45 mg/mL TID or vehicle (Part 1)EXPERIMENTALECF843 0.45 mg/mL TID or vehicle (Part 1)
ECF843 0.15 mg/mL TID or vehicle (Part 1)EXPERIMENTALECF843 0.15 mg/mL TID or vehicle (Part 1)
ECF843 vehicle TID (Part 1)PLACEBO_COMPARATORECF843 vehicle TID (Part 1)
ECF843 0.15 mg/mL BID or vehicle (Part 1)EXPERIMENTALECF843 0.15 mg/mL BID or vehicle (Part 1)
ECF843 vehicle BID (Part 1)PLACEBO_COMPARATORECF843 vehicle BID (Part 1)
Interventions
NameTypeDescription
ECF843DRUGTopical ocular eye drop
ECF843 vehicleOTHERTopical ocular eye drop
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Written informed consent must be obtained before any assessment * Adult male or female subjects 18 years of age or older * At least 6 months history of dry eye disease in both eyes * Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis * Compo...

Countries:United States
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