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ab aldeyra Aldeyra Therapeutics Achieves Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE Clinical Trial of Reproxalap in Allergic Conjunctivitis April 27 , 2021 • Statistical Significance Achieved for Primary Endpoint of Ocular Itching at All Prespecified Timepoints ( p < 0.0001 ) • Statistical Significance Achieved for Key Secondary Endpoint of Ocular Redness ( p < 0.0001 ) • Statistical Significance Achieved for Secondary Endpoints of Ocular Tearing ( p < 0.0001 ) and Total Ocular Severity Score ( p < 0.0001 ) • Results Consistent with Phase 3 ALLEVIATE Allergic Conjunctivitis Clinical Trial and Previous Chamber Results in Phase 2 Allergic Conjunctivitis Trial and Run - In Cohort of Phase 3 TRANQUILITY Dry Eye Disease Trial • Reproxalap Potentially Represents the First New Allergic Conjunctivitis Therapeutic Mechanism in Decades • Company to Discuss Results in Conference Call and Webcast at 8:00 a.m. ET Today LEXINGTON , Mass .-- ( BUSINESS WIRE ) -- Apr . 27 , 2021-- Aldeyra Therapeutics , Inc. ( Nasdaq : ALDX ) ( Aldeyra ) , a clinical - stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune - mediated diseases , today announced positive top - line results from the Phase 3 INVIGORATE Clinical Trial of 0.25 % reproxalap ophthalmic solution ( reproxalap ) , an investigational new drug , in patients with allergic conjunctivitis . The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints . " The statistically significant superiority of reproxalap over vehicle across all allergic conjunctivitis symptoms and signs assessed in INVIGORATE is remarkable , and suggests utility in one of the world's most common ocular surface diseases , " stated Todd C. Brady , M.D. , Ph.D. , President and CEO of Aldeyra . " We believe the consistent activity observed across chamber models in allergic conjunctivitis and dry eye disease bodes well for the commercial positioning of reproxalap as potentially the only broadly applicable topical anterior segment immune - modulating drug that may be used for chronic treatment , if approved for marketing . " The randomized , double - masked , vehicle - controlled , two - way crossover design allergen chamber Phase 3 INVIGORATE Trial enrolled 95 allergic conjunctivitis patients . The primary efficacy endpoint was change from baseline in subject - reported ocular itching score on a 0-4 point scale over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry . The key secondary endpoint was change from baseline in ocular redness on a 0-4 point scale over the duration of the allergen chamber ( approximately 3.5 hours ) . Relative to patients treated with vehicle , patients treated with reproxalap reported statistically significant ocular itching score reduction over all 11 prespecified primary endpoint comparisons ( p < 0.0001 for each comparison ) from 110 to 210 minutes in the allergen chamber . The reproxalap - treated patients demonstrated statistically significant reduction from baseline compared to vehicle ( p < 0.0001 ) for the key secondary endpoint of investigator- assessed ocular redness over the duration of the allergen chamber . Statistical significance was also achieved for the two secondary endpoints of change from baseline in patient - reported ocular tearing score on a 0-3 point scale over the duration of the allergen chamber ( p < 0.0001 ) and change from baseline in total ocular severity score ( 11 - point composite of the itching , redness , and tearing scores ) over the duration of the allergen chamber ( p < 0.0001 ) . " Ocular allergy is a market that is ripe for innovation , and allergic conjunctivitis sufferers know it , " said Milton Hom , OD , of Canyon City Eyecare in Azusa , CA. " Exacerbated by the rise in global temperatures , seasonal pollen counts are exploding , leading to escalations in the prevalence of allergic conjunctivitis and dry eye disease that are growing unchecked . Even with the availability of treatments over the counter , many patients are using more than one prescription to manage ocular symptoms and redness . Based on my review of the INVIGORATE data , reproxalap , as one of the first new therapeutic mechanisms of action in years , would be a meaningful complement to the current treatment paradigm for moderate - to - severe allergic conjunctivitis patients . " In the Phase 3 ALLEVIATE Trial , 0.25 % reproxalap demonstrated statistically significant reductions from vehicle in patient - reported ocular itching over one hour following direct topical conjunctival allergen challenge . In Aldeyra's Phase 2 allergen chamber trial , 0.25 % reproxalap demonstrated statistically significant reductions from vehicle in patient - reported ocular itching and investigator - assessed ocular redness . In the run - in cohort of the Phase 3 TRANQUILITY Trial in dry eye disease patients , 0.25 % reproxalap demonstrated statistically significant reductions from vehicle in patient- reported ocular dryness scores and investigator - assessed ocular redness in the dry eye chamber . The primary endpoint of the Phase 3 TRANQUILITY and TRANQUILITY - 2 trials is ocular redness over the duration of the chamber . Results from the TRANQUILITY trials in dry eye disease are expected in the second half of 2021 . Reproxalap ophthalmic solution has now been administered to more than 1,200 patients across 14 clinical trials . Consistent with prior clinical experience with reproxalap , there were no observed safety or tolerability concerns in the INVIGORATE Trial and no observed adverse events other than mild and transient instillation site discomfort typical of many prescribed topical ophthalmic medications for anterior segment inflammation .