Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (May 2025)
10 slides from Aldeyra Therapeutics's corporate update, May 6, 2025
Slide 1: Topline Data Release and NDA Resubmission Plan
Topline Data Release and NDA Resubmission Plan REPROXALAP FOR THE POTENTIAL TREATMENT OF DRY EYE DISEASE May 6, 2025 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2025 Exhibit 99.1
Slide 2: Disclaimers and Forward-Looking Statements
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 Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or assumed
Slide 3: Based on New Clinical Trial Results, Aldeyra Intends to Resubmit the NDA of Reproxalap
Based on New Clinical Trial Results, Aldeyra Intends to Resubmit the NDA of Reproxalap for the Potential Treatment of Dry Eye Disease † On April 3, 2025, Aldeyra announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (N
Slide 4: Dry Eye Chamber Trial Achieved the Primary Endpoint of Ocular Discomfort
The Phase 3 Dry Eye Chamber Trial Achieved the Primary Endpoint of Ocular Discomfort P value derived from primary endpoint mixed model for repeated measures analysis. Topical ocular reproxalap is an investigational drug candidate that has not been approved by the U.S. Food and Drug Administration; m
Slide 5: Ocular Discomfort Baselines Were Balanced Across Treatment Arms
In the Recently Completed Dry Eye Chamber Trial, Ocular Discomfort Baselines Were Balanced Across Treatment Arms Topical ocular reproxalap is an investigational drug candidate that has not been approved by the U.S. Food and Drug Administration; mild and transient instillation site irritation is the
Slide 6: Recently Completed Field Trial Did Not Reach Statistical Significance
The Recently Completed Field Trial Results, which Were Numerically Supportive of Reproxalap and Consistent with Prior Field Trials, Did Not Reach Statistical Significance Topical ocular reproxalap is an investigational drug candidate that has not been approved by the U.S. Food and Drug Administratio
Slide 7: Reproxalap Represents a Novel Potential Therapeutic Approach with Rapid Activity
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. Dry eye disease afflicts 39 million or more adults in the Unit
Slide 8: Positive Results Enable Potential NDA Resubmission of Reproxalap
Aldeyra Believes the Positive Results from the Phase 3 Dry Eye Chamber Trial Enable Potential NDA Resubmission† of Reproxalap for the Potential Treatment of Dry Eye Disease We believe that the results from the recently completed dry eye chamber trial, including no notable differences in baseline sco
Slide 9: Clinical and Regulatory Milestones
Dry Age-Related Macular Degeneration/Geographic Atrophy (ADX-631/ ADX-246) Investigational New Drug application expected to be submitted in 2025 Sjögren-Larsson Syndrome (ADX-629)* Phase 2 clinical trial pediatric cohort top-line results expected in 2025 Obesity/Hypertryglyceridemia (ADX-743) Invest
Slide 10: Well-Capitalized Biotechnology Company with a Broad Pipeline
PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA REVIEW† Rasp Platform for Immune-mediated and Metabolic Diseases Reproxalap Topical ocular administration Dry Eye Disease Dry Eye Disease Allergic Conjunctivitis Allergic Conjunctivitis ADX-629 Oral administration Sjögren-Larsson Syndrome* Sjögren-Larsson Synd