Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (April 2025)
11 slides from Aldeyra Therapeutics's corporate update, Apr 3, 2025
Slide 1: Reproxalap for the Potential Treatment of Dry Eye Disease: Regulatory Update
Exhibit 99.1 C O N F E R E N C E C A L L Reproxalap for the Potential Treatment of Dry Eye Disease: Regulatory Update April 3, 2025 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2025
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 Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or assum
Slide 3: Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease
3 Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The Complete Response Letter stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one addi
Slide 4: Aldeyra is Well Positioned to Execute on Potential NDA Resubmission Milestones
4 Aldeyra is Well Positioned to Execute on Potential NDA Resubmission Milestones • Top-line results from dry eye disease field and chamber clinical trials are expected in Q2 2025. With $101M in cash, cash • The majority of the costs for the additional trials equivalents, and marketable were incurred
Slide 5: Field Trial Design
5 Dry Eye Disease Field Trial Design Design Randomized, double-masked, parallel group, vehicle-controlled, environmental exposure Dosing Reproxalap or vehicle Further information Four-times-daily dosing for 4 weeks, followed by two-times-daily dosing for 2 weeks can be found on www.clinicaltrials.go
Slide 6: Pooled Data from Two Completed Field Trials Suggested Consistent Symptom Control Relative to Vehicle
6 Pooled Data from Two Completed Field Trials Suggested Consistent Symptom Control Relative to Vehicle P<0.0001 Pooled Analysis Weeks 1-6 RENEW-Part 1 The reproxalap (Induction-Maintenance) improvement from baseline was Phase 2 Formulation 10X more than that of vehicle. Topical ocular reproxalap is
Slide 7: Clinical Chamber Trial Design
7 Dry Eye Disease Clinical Chamber Trial Design Randomized, double-masked, parallel-group, Design vehicle-controlled, dry eye chamber challenge Trial Schematic • Visit 1: Screening vehicle dry eye chamber Visit 1 Visit 2 Visit 3 (dosing just before and 50 minutes after entry) Screening In-office Ran
Slide 8: Pooled Data from Three Completed Trials in the Same Chamber as the Ongoing Trial
8 Pooled Data from Three Completed Trials in the Same Chamber as the Ongoing Trial Supported Rapid Activity of Reproxalap Primary Endpoint Assessment Period P<0.0001 Pooled Analysis The vehicle increase from baseline was 148% higher than that Phase 2 Chamber Trial of reproxalap. TRANQUIILITY TRANQUI
Slide 9: Reproxalap Represents a Novel Potential Therapeutic Approach with Rapid Activity in Clinical Trials
9 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. Rapid and sustained Broad Acute reduction of symptom symptom
Slide 10: Clinical and Regulatory Milestones
10 • Dry Eye Disease (Reproxalap) Clinical and Completion of Field and Chamber Trials Expected in Q2 2025 Regulatory • Dry Eye Disease (Reproxalap) Potential NDA Resubmission Expected Mid-2025 Milestones • Allergic Conjunctivitis (Reproxalap) Positive Phase 3 INVIGORATE 2 trial top-line results anno
Slide 11: Aldeyra Is a Well-Capitalized Biotechnology Company with a Broad Immunology and Metabolic Pipeline
11 Aldeyra Is a Well-Capitalized Biotechnology Company with a Broad Immunology and Metabolic Pipeline † PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA REVIEW Rasp Platform for Immune-mediated and Metabolic Diseases Dry Eye Disease Reproxalap Option Topical ocular administration Agreement Allergic Conjuncti