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NS2

Phase 2

Non-infectious Anterior Uveitis | Small molecule | Ophthalmology |Aldeyra Therapeutics, Inc.|Last Updated: Mar 27, 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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02406209A Safety and Efficacy Study of NS2 in Patients With Anterior UveitisPHASE2 COMPLETED 45Mar 1, 2015Apr 1, 2016Mar 27, 202315 United States
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Study Endpoints
Primary Endpoints
Anterior Chamber Cell Grade at Week 8
The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NS2EXPERIMENTALNS2 ophthalmic drops (0.5%) in the affected eye
NS2 and Pred ForteEXPERIMENTALNS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Pred ForteACTIVE_COMPARATORPrednisolone acetate ophthalmic suspension (1%) in the affected eye
Interventions
NameTypeDescription
NS2DRUGNS2 ophthalmic drops (0.5%)
Prednisolone acetate ophthalmic suspension (1%)DRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Non-infectious anterior uveitis * Grade 1 - Grade 3 anterior chamber cell count * Subjects must have Intraocular pressure \<25 mmHg at baseline and may only administer a maximum of 1 topical medication to control Intraocular pressure in the study eye. * Visual acuity ≥ 20/200 ...

Countries:United States
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