Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (April 2021)
19 slides from Aldeyra Therapeutics's technical presentation, Apr 27, 2021
Slide 1: Top-Line Results from the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis
Exhibit 99.1 April 27, 2021 DATA RELEASE Top-Line Results from the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2021Exhibit 99.1 April 27, 2021 DATA RELEASE Top-Line Results from the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis Nasdaq: ALDX © A
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: Top-Line Results from Phase 3 INVIGORATE Clinical Trial of Reproxalap in Allergic Conjunctivitis
Top-Line Results from Phase 3 INVIGORATE Clinical Trial of Reproxalap in Allergic Conjunctivitis Statistical Significance Results Consistent with Phase 3 Achieved for: ALLEVIATE Allergic Conjunctivitis Clinical Trial and Previous Chamber Results in • Primary Endpoint of Ocular Itching at All Phase 2
Slide 4: The Prevalence of Allergic Conjunctivitis is Rising
The Prevalence of Allergic Conjunctivitis is Rising Allergic Rhinitis Allergic Allergic Conjunctivitis Asthma Allergic diseases Allergic conjunctivitis Temperatures Pollen is Allergy seasons are hyperendemic affects more than and CO levels spreading to are getting 2 and prevalence 1 billion people a
Slide 5: Reproxalap's Novel Mechanism of Action Has The Potential to Provide Differentiated Activity
Reproxalap’s Novel Mechanism of Action Has The Potential to Provide Differentiated Activity HISTAMINIC PHASE POST-HISTAMINIC PHASE REPROXALAP (minutes) (builds over hours) Irreversibly inhibits RASP, limiting allergic inflammation Potential to provide differentiated activity Cell Activation in post-
Slide 6: 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 The allergen chamber Subjects are exposed to naturalistic moderate allergen chamber. • enables a contr
Slide 7: The Phase 3 INVIGORATE Allergic Conjunctivitis Trial Design
The Phase 3 INVIGORATE Allergic Conjunctivitis Trial Design Design Primary Endpoint Randomized, two-way crossover, vehicle- Statistical significance in patient-reported controlled, double-masked allergen chamber ocular itching (0-4 scale) at a majority of 11 challenge timepoints between 110 and 210
Slide 8: The INVIGORATE Trial Achieved All Primary and Secondary Endpoints
The INVIGORATE Trial Achieved All Primary and Secondary Endpoints Primary Endpoint Both Secondary Endpoints Achieved Achieved Statistically significant improvement vs. Statistically significant improvement vs. vehicle (p<0.0001) over all 11 prespecified vehicle on secondary endpoints of timepoints o
Slide 9: Reproxalap Achieved Primary Endpoint of Reduction in Ocular Itching in the INVIGORATE Trial
Reproxalap Achieved Primary Endpoint of Reduction in Ocular Itching in the INVIGORATE Trial 2.0 KEY RESULTS Primary endpoint of statistical significance for majority of timepoints achieved over 1.5 prespecified time frame of 110-210 minutes after allergen chamber entry All timepoints within 110-210
Slide 10: Reproxalap Achieved Key Secondary Endpoint of Reduction in Ocular Redness in the INVIGORATE Trial
Reproxalap Achieved Key Secondary Endpoint of Reduction in Ocular Redness in the INVIGORATE Trial 1.6 KEY RESULTS Key secondary endpoint of statistical significance over the entire chamber 1.4 achieved (p<0.0001) Prophylactic and treatment effects of 1.2 reproxalap demonstrated Topical ocular reprox
Slide 11: Reproxalap Achieved Secondary Endpoint of Reduction in Ocular Tearing in the INVIGORATE Trial
Reproxalap Achieved Secondary Endpoint of Reduction in Ocular Tearing in the INVIGORATE Trial 1.2 KEY RESULTS Secondary endpoint of statistical 1.0 significance over the entire allergen chamber achieved (p<0.0001) 0.8 Prophylactic and treatment effects of reproxalap demonstrated 0.6 Topical ocular r
Slide 12: Reproxalap Achieved Secondary Endpoint of Reduction in Total Ocular Severity Score in the INVIGORATE Trial
Reproxalap Achieved Secondary Endpoint of Reduction in Total Ocular Severity Score in the INVIGORATE Trial 5 KEY RESULTS Secondary endpoint of statistical significance over the entire allergen 4 chamber achieved (p<0.0001) Prophylactic and treatment effects of 3 reproxalap demonstrated Topical ocula
Slide 13: Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in the INVIGORATE Trial
Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in the INVIGORATE Trial TOPICAL OCULAR NO observed safety or NO observed clinically REPROXALAP tolerability concerns significant findings on administered to safety assessments, more than NO discontinuations due to including
Slide 14: Reproxalap Has Demonstrated Consistent Success Across a Robust Clinical Development Program in Allergic Conjunctivitis
Reproxalap Has Demonstrated Consistent Success Across a Robust Clinical Development Program in Allergic Conjunctivitis Allergen Chamber Conjunctival Allergen Challenge PHASE 2a Phase 2 Allergen Chamber Trial 0.5% vs vehicle minutes hours in 0.25% and 0.5% vs vehicle 66 patients 100 patients 30 3.5 p
Slide 15: Allergic Conjunctivitis and Dry Eye Disease Are Interrelated Inflammatory Ocular Surface Diseases
Allergic Conjunctivitis and Dry Eye Disease Are Interrelated Inflammatory Ocular Surface Diseases The Three P’s of Ocular Surface Inflammation POLLENS POLLUTANTS PARCHED ENVIRONMENTS Irritating Air Allergens • Allergic response can “The clear interaction of allergy, compromise tear film dry eye and
Slide 16: Reproxalap Has Demonstrated Consistent Improvement in Symptoms Across Two Distinct Chamber Challenge Models
Reproxalap Has Demonstrated Consistent Improvement in Symptoms Across Two Distinct Chamber Challenge Models of Ocular Surface Disease ITCHING ITCHING DRYNESS Allergen Chamber Allergen Chamber Dry Eye Chamber INVIGORATE Phase 3 Trial Phase 2 Trial TRANQUILITY Run-In Cohort Topical ocular reproxalap i
Slide 17: Reproxalap Has Demonstrated Consistent Reduction of Ocular Redness Across Two Distinct Chamber Challenge Models
Reproxalap Has Demonstrated Consistent Reduction of Ocular Redness Across Two Distinct Chamber Challenge Models of Ocular Surface Disease REDNESS REDNESS REDNESS Allergen Chamber Allergen Chamber Dry Eye Chamber INVIGORATE Phase 3 Trial Phase 2 Trial TRANQUILITY Run-In Cohort Topical ocular reproxal
Slide 18: Upcoming Expected Reproxalap Development Milestones
* Upcoming Expected Reproxalap Development Milestones Reproxalap Reproxalap Reproxalap dry eye disease allergic conjunctivitis dry eye disease Phase 3 TRANQUILITY Phase 3 INVIGORATE Phase 3 TRANQUILITY main cohort initiation top-line results and TRANQUILITY-2 top- H1 2021 H1 2021 line results H2 202
Slide 19: A New Paradigm for the Treatment of Anterior Ocular Inflammation
A New Paradigm for the Treatment of Anterior Ocular Inflammation: * A Potential Single Approach for Dry Eye Disease and Allergic Conjunctivitis Dry Eye Disease Allergic Conjunctivitis REPROXALAP 0.25% REPROXALAP 0.25% Rapid symptom and redness Clinically significant and durable improvement within mi
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