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Reproxalap

Phase 3

Allergic Conjunctivitis | Small molecule | Other |Aldeyra Therapeutics, Inc.|Last Updated: May 14, 2026

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 Trials4
Total Enrollment596
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05234554The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic ConjunctivitisPHASE3 COMPLETED 131Jan 21, 2022Apr 22, 2023May 14, 20261 Canada
NCT04207736The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.PHASE3 COMPLETED 95Dec 5, 2019Feb 16, 2021Nov 20, 20241 Canada
NCT03494504ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic ConjunctivitisPHASE3 COMPLETED 318Mar 30, 2018Nov 5, 2018Feb 11, 20257 United States
NCT03660878A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic ConjunctivitisPHASE1 COMPLETED 52Sep 8, 2018Nov 19, 2019Apr 8, 20251 United States
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Study Endpoints
Primary Endpoints
Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber
110 to 210 minutes during allergen chamber exposure

The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.

Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber
The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.

Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.

Subject-reported Ocular Itching Score
Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.

Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.

Change From Baseline Ocular Itching Score on High Pollen Days
Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.

Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.

Secondary Endpoints
Conjunctival Redness Evaluated by the Investigator
12 to 212 minutes during allergen chamber exposure
Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber
The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
Number of Subjects With Two-point Reduction in Itching Score
Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Reproxalap Ophthalmic Solution (0.25%)EXPERIMENTAL -
Vehicle Ophthalmic SolutionPLACEBO_COMPARATOR -
Reproxalap Ophthalmic Solution (0.5%)EXPERIMENTAL -
Interventions
NameTypeDescription
Reproxalap Ophthalmic Solution (0.25%)DRUGReproxalap Ophthalmic Solution (0.25%) dosed twice.
Vehicle Ophthalmic SolutionDRUGVehicle Ophthalmic Solution dosed twice.
Reproxalap Ophthalmic Solution (0.5%)DRUGReproxalap Ophthalmic Solution (0.5%) administered once.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be at least 18 years of age at the time of screening of either sex or any race; * Provide written informed consent; * Be willing and able to follow instructions, and can attend all required clinical trial visits. * Have at least a two-year history of moderate-to-severe ragweed...

Countries:CanadaUnited States
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