Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (March 2019)
17 slides from Aldeyra Therapeutics's technical presentation, Mar 26, 2019
Slide 1: ALLEVIATE Phase 3 Allergic Conjunctivitis Top-Line Results
ALLEVIATE Phase 3 Allergic Conjunctivitis Top-Line Results March 2019 Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 Exhibit 99.1
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain 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
Slide 3: Allergic Conjunctivitis: A Common Disease with Unmet Medical Need
Many AC patients make significant sacrifices due to lack of drug activity AC patients experience symptoms throughout all decades of adult life 20s AC 40s 60s 80s Large Disease Burden Allergic Conjunctivitis: A Common Disease with Unmet Medical Need Under-served Patient Population 20% globally 20% or
Slide 4: Allergic Conjunctivitis Impairs Many Aspects of Daily Life
Allergic Conjunctivitis Impairs Many Aspects of Daily Life Patient associations with AC: “It affects me every day. …Family members say my eyes look awful and are so bloodshot. It's worst in the early fall and late spring…” - AC patient Many AC patients also experience dry eye disease symptoms Diagno
Slide 5: Positive Allergic Conjunctivitis Clinical Trial Results
Positive ALLEVIATE Phase 3 Allergic Conjunctivitis Clinical Trial Results Reproxalap: A Novel Drug Candidate for the Treatment of Ocular Inflammation Primary and key secondary endpoints achieved for 0.25% and 0.5% concentrations: Statistically significant improvement vs. vehicle (p < 0.0001 and p =
Slide 6: Novel Mechanism of Action has the Potential to Provide Differentiated Activity Versus Antihistamines
Novel Mechanism of Action has the Potential to Provide Differentiated Activity Versus Antihistamines Reproxalap has the potential to be uniquely effective in post-histaminic allergy, which affects all allergic conjunctivitis patients Histaminic Phase Post-Histaminic Phase (Cells, cytokines, and othe
Slide 7: Allergic Conjunctivitis Clinical Trial Design
ALLEVIATE Phase 3 Allergic Conjunctivitis Clinical Trial Design Phase 3 Conjunctival Allergen Challenge Trial Primary objective: Evaluate efficacy of reproxalap ophthalmic solutions (0.25% & 0.5%) compared to vehicle for the treatment of ocular itching associated with acute allergic conjunctivitis I
Slide 8: ALLEVIATE Primary Endpoint Achieved For Both Concentrations of Reproxalap
Improvement in itch score over one hour after allergen exposure statistically greater for reproxalap vs. vehicle ALLEVIATE Primary Endpoint Achieved For Both Concentrations of Reproxalap Source: ALLEVIATE allergic conjunctivitis Phase 3 clinical trial results; Ocular itch scale 0 (no itch) to 4 (inc
Slide 9: ALLEVIATE Key Secondary Endpoint Achieved For Both Concentrations of Reproxalap
ALLEVIATE Key Secondary Endpoint Achieved For Both Concentrations of Reproxalap Generalized estimating equation analysis Source: ALLEVIATE allergic conjunctivitis Phase 3 clinical trial results p = 0.0005 for 0.25% reproxalap p = 0.0169 for 0.5% reproxalap Probability of Two-Point Response: Ocular I
Slide 10: Reproxalap Statistically Superior to Vehicle in Complete Resolution of Ocular Itch
In ALLEVIATE, Reproxalap Was Statistically Superior to Vehicle in Achieving Complete Resolution of Ocular Itch Probability of Therapeutic Cure (Zero Itch) Post-Allergen Challenge: Complete resolution of ocular itch (zero itch score) response rate with reproxalap statistically superior to vehicle, co
Slide 11: Topical Ocular Reproxalap: No Observed Safety Concerns and Generally Well Tolerated
Topical Ocular Reproxalap: No Observed Safety Concerns and Generally Well Tolerated in ALLEVIATE Now administered to over 700 patients across seven completed clinical trials No observed safety or tolerability concerns No adverse events other than mild, transient instillation site irritation, consist
Slide 12: Planned Phase 3 Allergic Conjunctivitis Program
Planned Phase 3 Allergic Conjunctivitis Program Remaining clinical requirements for potential New Drug Application submission expected to be confirmed H2 2019, following discussion with regulatory authorities Aldeyra is conducting clinical method development studies to assess the feasibility of meas
Slide 13: Reproxalap: A Unique and Novel Product Candidate for Allergic Conjunctivitis and Dry Eye Disease
Active in post-histaminic allergy Clinically significant and durable symptom response in Phase 3 clinical trial Reproxalap: A Unique and Novel Product Candidate for Allergic Conjunctivitis and Dry Eye Disease Allergic Conjunctivitis Dry Eye Disease Reproxalap Reproxalap in Allergic Conjunctivitis Pa
Slide 14: Parallel Allergic Conjunctivitis and Dry Eye Disease Phase 3 Clinical Programs
ALLEVIATE Phase 3 Parallel Allergic Conjunctivitis and Dry Eye Disease Phase 3 Clinical Programs Support Potential Concurrent NDA Filings Adaptive DED Phase 3 (Part 1) Adaptive DED Phase 3 (Part 2) Confirmatory DED Phase 3 Expected initiation H1 2019 Phase 3 DED Safety Study Phase 3 AC Safety Study
Slide 15: Anticipated Milestones
Anticipated Milestones Anticipated Milestones Allergic Conjunctivitis Dry Eye Disease Late-Stage Development for Allergic Conjunctivitis and Dry Eye Disease Initiated reproxalap ALLEVIATE Phase 3 clinical trial in allergic conjunctivitis April 2018 Positive reproxalap ALLEVIATE Phase 3 clinical tria
Slide 16: Deep and Innovative Pipeline Focused on Immune-Mediated Diseases
Ocular Inflammation Deep and Innovative Pipeline Focused on Immune-Mediated Diseases Ocular Diseases Indication Compound Disease Area Preclinical Phase 1 Phase 2 Phase 3 Next Anticipated Milestone = Positive Phase 2/3 clinical trial data reported in 2016-2019 Trial initiations contingent on funding,
Slide 17: Eight Successful Phase 2/3 Clinical Trials 2016-2019
Three Mechanisms of action in development Eight Successful Phase 2/3 Clinical Trials 2016-2019 Phase 2/3 count includes mesothelioma investigator-sponsored trial; Phase 3 trials contingent on funding, regulatory review, and other factors. Five Phase 3 Clinical Programs Ongoing or Expected to Initiat
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