Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (June 2023)
16 slides from Aldeyra Therapeutics's technical presentation, Jun 15, 2023
Slide 1: Top-Line Results from the Phase 3 INVIGORATE-2 Trial in Allergic Conjunctivitis
Top-Line Results from thePhase 3 INVIGORATE-2 Trial in Allergic Conjunctivitis DATA RELEASE June 15, 2023 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2023
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: INVIGORATE-2 Trial of Reproxalap Achieved All Primary and Secondary Endpoints
The Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Achieved All Primary and Secondary Endpoints Statistical significance was achieved for: The primary endpoint of reduction in ocular itching at all prespecified timepoints (P<0.0001) The key secondary endpoint of reduction in ocu
Slide 4: The Allergen Chamber: A Demanding Real-World Drug Assessment
The Allergen Chamber:A Demanding Real-World Drug Assessment in Allergic Conjunctivitis Slide source: Cliantha Research The allergen chamber Enables a controlled, environmental allergen exposure that mimics real-world exposure to airborne allergens Allows for detailed assessment of prophylaxis and tr
Slide 5: INVIGORATE-2 Allergic Conjunctivitis Trial Design
The Phase 3 INVIGORATE-2 Allergic Conjunctivitis Trial Design Design Randomized, two-way crossover, vehicle-controlled, double-masked allergen chamber challenge design with 0.25% topical ocular reproxalap Chamber Exposure & Dosing Schedule 3.5 hours continuous allergen exposure First dose just befor
Slide 6: The INVIGORATE-2 Trial Achieved All Primary and Secondary Endpoints
The INVIGORATE-2 Trial Achieved All Primary and Secondary Endpoints P values derived from mixed effect model of repeated measures analysis. Topical ocular reproxalap is an investigational drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and tran
Slide 7: Achieved Primary Endpoint of Reduction in Ocular Itching
Reproxalap Achieved Primary Endpoint of Reduction inOcular Itching in the INVIGORATE-2 Trial Primary endpoint of statistical significance for majority of timepoints achieved over prespecified time frame of 110-210 minutes after allergen chamber entry in change from baseline in patient-reported ocula
Slide 8: Achieved Key Secondary Endpoint of Reduction in Ocular Redness
Reproxalap Achieved Key Secondary Endpoint of Reduction in Ocular Redness in the INVIGORATE-2 Trial Key secondary endpoint of statistical significance in change from baseline in investigator-assessed ocular redness over the entire chamber achieved (P=0.004) Prophylactic and treatment effects of repr
Slide 9: Achieved Secondary Endpoint of Reduction in Ocular Tearing
Reproxalap Achieved Secondary Endpoint of Reduction inOcular Tearing in the INVIGORATE-2 Trial Secondary endpoint of statistical significance in change from baseline in patient-reported ocular tearing score over the entire allergen chamber achieved (P<0.0001) Prophylactic and treatment effects of re
Slide 10: Achieved Secondary Endpoint of Reduction in Total Ocular Severity Score
Reproxalap Achieved Secondary Endpoint of Reduction inTotal Ocular Severity Score in the INVIGORATE-2 Trial Secondary endpoint of statistical significance in total ocular severity score, a composite of patient-reported ocular itching and tearing scores and investigator-assessed ocular redness score
Slide 11: Generally Well Tolerated and No Safety Concerns Observed
Reproxalap Was Generally Well Tolerated and No Safety Concerns Were Observed in the INVIGORATE-2 Trial No observed safety or tolerability concerns No discontinuations due to adverse events Consistent with other topically administered drugs, most common treatment-emergent adverse events related to tr
Slide 12: Consistent Improvement in Ocular Itching Across Late-Stage Trials
Reproxalap Demonstrated Consistent Improvement in Ocular Itching Symptoms Across Late-Stage Allergic Conjunctivitis Clinical Trials Consistent statistically significant symptomatic activity of reproxalap over vehicle in patients with allergic conjunctivitis demonstrated across Phase 2 and Phase 3 al
Slide 13: Consistent Reduction of Ocular Redness Across Two Chamber Challenge Models
Reproxalap Demonstrated Consistent Reduction of Ocular Redness Across Two Distinct Crossover Chamber Challenge Models of Ocular Surface Disease Consistent statistically significant activity of reproxalap over vehicle in reduction of ocular redness demonstrated across Phase 2 and Phase 3 chamber tria
Slide 14: Allergic Conjunctivitis and Dry Eye Disease Are Interrelated Inflammatory Diseases
Allergic Conjunctivitis and Dry Eye Disease Are Interrelated Inflammatory Ocular Surface Diseases Slide sources: *Concepts adapted from “The Whipsaw of Allergic Dry Eye” by Mark B. Abelson, MD and Lauren Lilyestrom in REVIEW of Ophthalmology; October 2008; and Ann Allergy Asthma Immunol, 108(3): 163
Slide 15: Aldeyra Has Submitted Comprehensive Dry Eye Disease NDA
Aldeyra Has Submitted What is Believed to be the Most Comprehensive Dry Eye Disease NDA, which Includes Symptoms and Multiple Signs† †The NDA submission includes a combination of primary, secondary, multiplicity-adjusted, and nominal P-value endpoints. ‡Adequate and well-controlled Phase 2 or Phase
Slide 16: Upcoming Regulatory and Clinical Milestones
†Regulatory review timelines are flexible and subject to change based on the regulator's workload and other potential review issues. ‡The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients. *Invest
Aldeyra Therapeutics — Technical Presentation (June 2023) on 6ix