Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (July 2022)
16 slides from Aldeyra Therapeutics's technical presentation, Jul 12, 2022
Slide 1: Top-Line Results from the Dry Eye Disease Chamber Crossover Trial of Reproxalap
Top-Line Results from theDry Eye Disease Chamber Crossover Trial of Reproxalap July 12, 2022 NASDAQ: ALDX ©Aldeyra Therapeutics, Inc. 2022
Slide 2: Forward-looking statements
2 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, including statements regarding Aldeyra’
Slide 3: Dry Eye Disease Crossover Trial Achieved Success for Three Sign Endpoints and Six Symptom Endpoints
3 The ocular redness primary endpoint was achieved (P=0.0004). The Schirmer test primary endpoint was achieved (P=0.0005). The multiplicity-controlled secondary endpoint of Schirmer test ≥10mm responder analysis was achieved (P=0.0361). Secondary endpoints for each assessed symptom (dryness, discomf
Slide 4: Aldeyra Intends to Submit Symptom and Three Sign Endpoints to Support Dry Eye Disease NDA
4 Aldeyra Intends to Submit Symptom and Three Sign Endpoints to Support Dry Eye Disease NDA Efficacy Requirements† †NDA submission requirements depend, in part, on clinical safety results and regulatory feedback. Topical ocular reproxalap is an investigational new drug candidate that has been studie
Slide 5: Crossover Trial Represents a Unique Clinical Paradigm and Was Designed to Serve as Pivotal Trial
5 The Crossover Trial Represents a Unique Clinical Paradigm in Dry Eye Disease and Was Designed to Serve as a Pivotal Trial †NDA submission requirements depend, in part, on clinical safety results and regulatory feedback. Topical ocular reproxalap is an investigational new drug candidate that has be
Slide 6: Crossover Trial Design
Design Randomized, double-masked, crossover, vehicle-controlled, single-center Dosing 0.25% reproxalap or vehicle, two-week washout Day 1: four doses Day 2: one dose before 90-minute dry eye chamber, one dose 45 minutes after chamber entry Size 63 patients Primary Endpoints† Schirmer test on Day 1 (
Slide 7: Both Primary Endpoints Statistically Significant in Favor of Reproxalap over Vehicle
7 P values derived from mixed effect model of repeated measures of change from baseline. Source: Dry eye disease crossover clinical trial results on file. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 1,800 patients with no observed safety conc
Slide 8: Within-Patient Clinical Relevance Assessments Demonstrated Reproxalap Superiority
8 *P < 0.05. SEM = standard error of the mean. mm = millimeter. Source: Dry eye disease crossover clinical trial results on file. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 1,800 patients with no observed safety concerns; mild and transient
Slide 9: Schirmer Test ≥10mm Responder Secondary Endpoint Was Achieved
9 Reproxalap Vehicle ≥10 mm tear production post-Dose #4 on Day 1 48% 41% Odds ratio (95% confidence interval)† 1.551 (1.029, 2.338) P value versus vehicle† 0.0361 † Generalized estimating equation analysis of Schirmer test score ≥10mm pre- and post-Dose #4 on Day 1. Source: Dry eye disease crossove
Slide 10: Secondary Endpoints for All Assessed Symptoms Were Achieved
10 P values derived from mixed effect model of repeated measures of change from baseline. Source: Dry eye disease crossover clinical trial results on file. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 1,800 patients with no observed safety con
Slide 11: Summary of Crossover Trial Results and Next Steps
11 The results suggest that a crossover design may reduce the high degree of variability characteristic of dry eye disease clinical trials. The primary endpoints of ocular redness and Schirmer test were achieved. The Schirmer test ≥10mm responder analysis, which was also achieved, correlates with sy
Slide 12: Reproxalap May Address Significant Unmet Needs in Dry Eye Disease
12 Reproxalap May Have the Potential to Address Significant Unmet Needs in Dry Eye Disease †Holland EJ, Cavanagh B, Machatha ST, et al. The Novel RASP Modulator Reproxalap Rapidly Improves Signs and Symptoms of Dry Eye Disease: The TRANQUILITY Run-In Cohort. Paper session presented at: Ocular Surfac
Slide 13: Discontinuation and Switching Rates Are Early and Prevalent with Current Dry Eye Therapies
With Currently Available Dry Eye Disease Therapies, Discontinuation and Switching Rates are Early and Prevalent for Most Patients Sources: White DE, Zhao Y, Ogundele A, Fulcher N, Acs A, Moore-Schiltz L, Karpecki PM. Real-World Treatment Patterns Of Cyclosporine Ophthalmic Emulsion And Lifitegrast O
Slide 14: Surveyed Eyecare Providers Viewed Reproxalap's Potential Benefits Highly Favorably
Dryness Source: Eyecare provider Interviews (n=40); ClearView analysis of market research conducted Q4 2021 – Q1 2022. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 1,800 patients with no observed safety concerns; mild and transient instillatio
Slide 15: Patient Research Indicates Value for Therapy Reducing Symptomatic Burden and Redness
Patient Research Indicates Value for a Dry Eye Disease Therapy that May Reduce Symptomatic Burden and Ocular Redness Source: Patient Interviews (n=40); ClearView analysis of market research conducted Q4 2021 – Q1 2022. Topical ocular reproxalap is an investigational new drug candidate that has been
Slide 16: Pending FDA Feedback, Reproxalap Could Be First Dry Eye Drug Approved on Multiple Objective Signs
16 Pending FDA Feedback, Reproxalap Has the Potential to Be the First Dry Eye Disease Drug Approved Based on Multiple Objective Signs Drug Indication Excerpt from Label Clinical Data in Label Restasis® Increase tear production in patients whose tear production is presumed to be suppressed due to ocu
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