Aldeyra Therapeutics, Inc. · NASDAQ:ALDX

Aldeyra Therapeutics — Technical Presentation (October 2019)

16 slides from Aldeyra Therapeutics's technical presentation, Oct 31, 2019

  1. Slide 1: Allergic Conjunctivitis Allergen Chamber Clinical Methods Trial Expanded Data Release

    Exhibit 99.1 October 31, 2019 DATA RELEASE Allergic Conjunctivitis Allergen Chamber Clinical Methods Trial Expanded Data Release Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2019Exhibit 99.1 October 31, 2019 DATA RELEASE Allergic Conjunctivitis Allergen Chamber Clinical Methods Trial Expanded Data Rele

  2. 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

  3. Slide 3: The Prevalence and Economic Burden of Allergic Conjunctivitis is Rising

    The Prevalence and Economic Burden of Allergic Conjunctivitis is Rising Allergic Allergic Rhinitis Conjunctivitis Allergic diseases are Allergic conjunctivitis affects hyperendemic and more than 1 billion people prevalence is increasing worldwide, including 100 Allergic million in the U.S. Asthma Te

  4. Slide 4: Physicians and Patients Say That Currently Available Treatments Are Inadequate

    Physicians and Patients Say That Currently Available Treatments Are Inadequate Up to 30 million of allergic Antihistamines are not 30 conjunctivitis sufferers in the U.S. effective in an estimated million % do not respond adequately to or are 24% of treated allergic 24 dissatisfied with antihistamin

  5. Slide 5: Reproxalap's Novel Mechanism of Action Has The Potential to Provide Differentiated Activity Versus Antihistamines

    Reproxalap’s Novel Mechanism of Action Has The Potential to Provide Differentiated Activity Versus Antihistamines Histaminic Phase Post-Histaminic Phase Reproxalap (minutes) (builds over hours) • Reproxalap irreversibly inhibits Cell activation RASP, limiting allergic inflammation. RASP • Reproxalap

  6. Slide 6: The Allergen Chamber is Designed to Mimic Real-World Exposure to Airborne Allergens With Control and Consistency

    The Allergen Chamber is Designed to Mimic Real-World Exposure to Airborne Allergens With Control and Consistency Clinical Model Comparison For Allergic Conjunctivitis Clinical Trial Design Conjunctival Allergen Allergen Allergen Field Study Chamber Challenge Patients administer drug at Investigator

  7. Slide 7: The Allergen Chamber: A Demanding Real-World Drug Assessment in Allergic Conjunctivitis

    The Allergen Chamber: A Demanding Real-World Drug Assessment in Allergic Conjunctivitis • To our knowledge, no late-stage investigational allergic conjunctivitis drug has been rigorously tested in an allergen chamber. • The allergen chamber enables a controlled, environmental allergen exposure that

  8. Slide 8: Reproxalap Allergen Chamber Trial Design

    * Reproxalap Allergen Chamber Clinical Trial Design • Primary objective: Three-Way Randomized Crossover • Evaluate efficacy of reproxalap ophthalmic solution vs. vehicle to confirm dosing regimen and sample size for Phase 3 clinical N=22 N=22 N=22 testing • Inclusion/exclusion criteria: Reproxalap 0

  9. Slide 9: Reproxalap Showed Greater and More Durable Clinical Responses Than Vehicle in Ocular Itch and Redness

    Reproxalap Showed Greater and More Durable Clinical Responses Than Vehicle in Allergen Chamber Clinical Trial Ocular Itch Score (0-100) During 3.5 Hours of Allergen Exposure Ocular Redness Score (0-4) During 3.5 Hours of Allergen Exposure MMRM p < 0.0001 MMRM p < 0.0001 First Dose First Dose 5 min B

  10. Slide 10: Reproxalap Demonstrated Prophylactic and Treatment Activity in Total Ocular Symptom Score

    Reproxalap Demonstrated Prophylactic and Treatment Activity in Allergen Chamber Clinical Trial Total Ocular Symptom Score (0-11 scale) During 3.5 Hours of Allergen Exposure MMRM p < 0.0001 First Dose 5 min Before Chamber Entry Statistically significant reduction in all assessed ocular symptoms and s

  11. Slide 11: Fewer Reproxalap-Treated Subjects Reached Sustained Ocular Itch Scores Relative to Vehicle

    Relative to Vehicle Treatment, Fewer Reproxalap-Treated Subjects Reached Sustained Ocular Itch Scores >2 in Allergen Chamber Clinical Trial Proportion of Subjects with Sustained Ocular Itch Scores >2 (0-4 Scale) Development of sustained ocular itch scores of greater than or equal to 2 (scale 0 – 4)

  12. Slide 12: Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed

    Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in Allergen Chamber Clinical Trial • No observed safety or tolerability concerns • Most common treatment-emergent event was transient instillation site irritation • No observed findings on safety assessments: • Visual Acuit

  13. Slide 13: The INVIGORATE Phase 3 Clinical Trial Design

    The INVIGORATE Phase 3 Clinical Trial Design • Primary endpoint: Two-Way Randomized Crossover • Statistical significance in ocular itch (0-4 scale) at a majority of eleven time points between 110 and 210 minutes N≈50 N≈50 • Secondary endpoints: • Investigator-assessed ocular redness score Reproxalap

  14. Slide 14: Confirmed INVIGORATE Phase 3 Primary Endpoint Achieved in Ocular Itching Score

    Confirmed INVIGORATE Phase 3 Primary Endpoint * Achieved in Allergen Chamber Clinical Trial Ocular Itching Score (0-4) During 3.5 Hours of Allergen Exposure Allergen chamber time p value point 112 0.0002 122 0.0004 132 0.0002 142 0.0044 152 0.0001 172 <0.0001 192 <0.0001 First Dose 212 0.0002 5 min

  15. Slide 15: INVIGORATE Phase 3 Trial Design And Primary Endpoint Confirmed; Positive Allergen Chamber Results

    INVIGORATE Phase 3 Trial Design And Primary Endpoint Confirmed Positive Allergen Chamber INVIGORATE Clinical Trial Results Phase 3 Clinical Trial • Reproxalap showed greater and durable clinical • Design and primary endpoint agreement responses vs. vehicle with FDA on October 1, 2019 • Statistically

  16. Slide 16: Upcoming and Recently Achieved Development Milestones

    * Upcoming and Recently Achieved Development Milestones: Novel Approaches to Address Immune-Mediated Disease = Ocular Diseases = Systemic Diseases Reproxalap allergic conjunctivitis design for ADX-629 systemic Phase 1 clinical trial initiation INVIGORATE Phase 3 confirmed October 2019 H2 2019 ADX-21

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