Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (August 2024)
8 slides from Aldeyra Therapeutics's corporate update, Aug 8, 2024
Slide 1: Reproxalap Clinical Development and Regulatory Update: Top-Line Results
Dry Eye Disease Chamber Phase 3 Clinical Trial of Reproxalap REPROXALAP CLINICAL DEVELOPMENT AND REGULATORY UPDATE August 8, 2024 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2024 TOP - LINE RESULTS
Slide 2: Disclaimers and Forward-Looking Statements
2 Disclaimers and Forward - Looking Statements This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Sec urities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or
Slide 3: Phase 3 Dry Eye Chamber Trial Designed to Satisfy NDA Resubmission Requirements
3 The Phase 3 Clinical Trial of Reproxalap in a Dry Eye Chamber was Designed to Satisfy the Requirements for NDA Resubmission † z • Randomized, double - masked, vehicle - controlled dry eye chamber challenge Design • Visit 1: Medical screening • Visit 2: Vehicle dry eye chamber (dosing just before a
Slide 4: Dry Eye Chamber Trial Achieved Success for Primary Endpoint of Ocular Discomfort
4 The Phase 3 Dry Eye Chamber Clinical Trial Achieved Success for the Primary Endpoint of Ocular Discomfort P value derived from primary endpoint mixed model for repeated measures analysis. Topical ocular reproxalap is an investigati ona l new drug candidate that has been studied in more than 2,500
Slide 5: Aldeyra Believes Symptom Requirements for NDA Resubmission Have Been Met
5 Aldeyra Believes that Symptom Requirements for Dry Eye Disease NDA Resubmission Have Been Met The Phase 3 dry eye chamber clinical trial symptom results are consistent with field trial symptom results previously reviewe d b y the FDA. Estimates based on mixed model for repeated measures analysis a
Slide 6: Positive Results Enable NDA Resubmission of Reproxalap
6 Aldeyra Believes that Positive Results from the Phase 3 Clinical Trial Enable NDA Resubmission † of Reproxalap for Dry Eye Disease • The dry eye chamber clinical trial was designed to satisfy the FDA’s single resubmission requirement of “at least one additional adequate and well - controlled study
Slide 7: Exclusive Option Agreement with AbbVie for Reproxalap License
7 Aldeyra has Entered into an Exclusive Option Agreement with AbbVie Inc. for License to Develop and Commercialize Reproxalap Option for AbbVie to obtain: • Co - exclusive license to develop, manufacture, and commercialize reproxalap in the U.S. • Exclusive license to develop, manufacture, and comme
Slide 8: Reproxalap: Novel Potential Therapeutic Approach with Rapid Activity in Clinical Trials
8 Reproxalap Represents a Novel Potential Therapeutic Approach in Dry Eye Disease with Rapid Activity in Clinical Trials Potential advantages for patients and healthcare providers could effect a paradigm shift relative to standard of care. † Company estimates and Am J Ophthalmol . 2014;157(4):799 -
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