Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (September 2026)
11 slides from Aldeyra Therapeutics's corporate update, Sep 29, 2026
Slide 1: Reproxalap for the Potential Treatment of Dry Eye Disease: Regulatory Update
Exhibit 99.1 CONFERENCE CALL Reproxalap for the Potential Treatment of Dry Eye Disease: Regulatory Update September 29, 2026 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2026
Slide 2: Disclaimers and Forward-Looking Statements
Exhibit 99.1 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 poss
Slide 3: Aldeyra Intends to Submit a Formal Dispute Resolution Request Regarding Reproxalap
Exhibit 99.1 3 Aldeyra Intends to Submit a Formal Dispute Resolution Request Regarding Reproxalap for the Treatment of Dry Eye Disease Following a New Drug Application (NDA) submission and two NDA resubmissions of reproxalap for the treatment of dry eye disease, Aldeyra has received three Complete R
Slide 4: FDRR is an Established Process with Uncertain Timelines
Exhibit 99.1 4 FDRR is an Established Process with Uncertain Timelines The FDRR process is subject to PDUFA goals. FDRR guidance† states that a meeting requested as part of the FDRR should be treated as a Type A meeting and held within 30 days after submission of the FDRR. The decision on the FDRR s
Slide 5: Totality of Evidence Indicates a Clear Pattern of Superiority over Vehicle Control
Exhibit 99.1 5 Aldeyra Believes That the Totality of Evidence Indicates a Clear Pattern of Superiority of Reproxalap over the Vehicle Control Reproxalap Improvement Favors Reproxalap Trial Design Endpoint vs. Vehicle (%) 012 Field Symptoms 204% 012 Field Staining 21% 013 Field Symptoms 62% 019 Chamb
Slide 6: Majority of Reproxalap Dry Eye Trials Submitted to NDA Achieved Primary Endpoints
Exhibit 99.1 6 The Majority of Reproxalap Dry Eye Trials Submitted to the Dry Eye Disease NDA Achieved Primary Endpoints Supporting Efficacy TRIAL PRIMARY ENDPOINT(S) P<0.05 FDA POSITION ALDEYRA POSITION Symptoms ✓ 012 Co-primary not met Supportive for symptoms Staining 013 Symptoms ✓ Endpoint met E
Slide 7: Half of Trials Supporting Dry Eye Drug Approvals Fail to Meet All Primary Endpoints
Exhibit 99.1 7 Half of Trials Supporting Dry Eye Drug Approvals Fail to Meet All Primary Endpoints Across pivotal trials for approved dry eye drugs, 11 of 22 (50%) met all prespecified endpoints. 18% 32% 50% Failed All Primaries Failed Co-primary All Primaries Met For the 8 approved dry eye 4 of 22
Slide 8: Reproxalap Represents a Novel Potential Therapeutic Approach in Dry Eye Disease
Exhibit 99.1 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. Rapid and Broad Acute tear sustained symptomati
Slide 9: Aldeyra is Well Positioned to Execute on the FDRR Process and Continue Pipeline Advancement
Exhibit 99.1 9 Aldeyra is Well Positioned to Execute on the FDRR Process and Continue Pipeline Advancement With $45.1M in cash and cash equivalents as of 6/30/2026, Aldeyra is well positioned to • FDRR submission and meeting with OND execute on the FDRR process expected in Q4 2026. for reproxalap an
Slide 10: Aldeyra Is a Well-Capitalized Biotechnology Company with a Broad Immunology Pipeline
Exhibit 99.1 10 Aldeyra Is a Well-Capitalized Biotechnology Company with a Broad Immunology Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA REVIEW RASP Platform for Immune-Mediated Diseases Dry Eye Disease Reproxalap Option Topical ocular administration Agreement Allergic Conjunctivitis Atopic Derm
Slide 11: Clinical and Regulatory Milestones
Exhibit 99.1 11 Clinical and Reproxalap • Dry Eye Disease (Reproxalap) FDRR meeting with the FDA OND expected the fourth quarter of 2026† Regulatory Milestones • Primary Vitreoretinal Lymphoma (ADX-2191) Phase 3 clinical trial initiation expected in 2027‡ ADX-2191 • Atopic Dermatitis (ADX-248) Timel
Aldeyra Therapeutics — Corporate Update (September 2026) on 6ix