Brief: Aldeyra Therapeutics Announces Achievement Of Statistical Significance For Primary Endpoint In Phase 3 Invigorate‑2 Trial Of Reproxalap In Allergic Conjunctivitis

Aldeyra Therapeutics

15/06/2023 12:08

June 15 (Reuters) - Aldeyra Therapeutics Inc  ALDX.O :
    * ALDEYRA THERAPEUTICS ANNOUNCES ACHIEVEMENT OF STATISTICAL
SIGNIFICANCE FOR PRIMARY ENDPOINT AND ALL SECONDARY ENDPOINTS IN
PHASE 3 INVIGORATE-2 TRIAL OF REPROXALAP IN ALLERGIC
CONJUNCTIVITIS
    * ALDEYRA THERAPEUTICS INC: STATISTICAL SIGNIFICANCE
ACHIEVED FOR
PRIMARY ENDPOINT OF OCULAR ITCHING AT ALL PRESPECIFIED
TIMEPOINTS (P<0.0001)
    * ALDEYRA THERAPEUTICS INC: STATISTICAL SIGNIFICANCE
ACHIEVED FOR
KEY SECONDARY ENDPOINT OF OCULAR REDNESS (P=0.004)
    * ALDEYRA THERAPEUTICS INC: STATISTICAL SIGNIFICANCE
ACHIEVED FOR
SECONDARY ENDPOINTS OF OCULAR TEARING (P<0.0001) AND TOTAL
OCULAR SEVERITY SCORE (P<0.0001)
    * ALDEYRA THERAPEUTICS INC: RESULTS CONSISTENT WITH PREVIOUS
PHASE
2 AND PHASE 3 CLINICAL TRIALS IN ALLERGIC CONJUNCTIVITIS
    * ALDEYRA THERAPEUTICS INC: ACTIVITY IN ALLERGIC
CONJUNCTIVITIS
COMPLEMENTS COMMERCIAL POTENTIAL IN DRY EYE DISEASE
    * ALDEYRA THERAPEUTICS INC: NDA PRESCRIPTION DRUG USER FEE
ACT
(PDUFA) DATE FOR REPROXALAP FOR TREATMENT OF DRY EYE DISEASE IS
NOVEMBER 23, 2023
    * ALDEYRA THERAPEUTICS INC: NO PATIENTS DISCONTINUED DUE TO
ADVERSE EVENTS, AND 130 OF 131 RANDOMIZED PATIENTS COMPLETED
CLINICAL TRIAL

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