Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (July 2022)
10 slides from Aldeyra Therapeutics's technical presentation, July 2022
Slide 1: The Novel RASP Modulator Reproxalap Rapidly Improves Signs and Symptoms of Dry Eye Disease
The Novel RASP Modulator Reproxalap Rapidly Improves Signs and Symptoms of Dry Eye Disease: The TRANQUILITY Run-In Cohort Edward J Holland,1 Bill Cavanagh,2 Stephen G Machatha,2 Todd C Brady2 Professional medical writing and editorial assistance were provided by Mark Loughlin, PhD, at NexGen Healthc
Slide 2: Disclosures
Disclosures • EJ Holland • B Cavanagh reports employment with and stock ownership in Aldeyra Therapeutics. • SG Machatha reports employment, patent interests, and stock ownership with Aldeyra Therapeutics. • TC Brady reports employment, patent interests, and stock ownership with Aldeyra Therapeutics
Slide 3: Introduction
Introduction • Dry eye disease (DED) is a chronic, progressive ocular surface disorder of multifactorial etiology.1 • ~15% of the adult US population (39 million) has DED2; however, treatments that provide fast, effective, and sustained relief are lacking.3,4 • The novel RASP modulator, reproxalap,
Slide 4: RASP are Believed to Work at the Top of the Inflammatory Cascade
RASP are Believed to Work at the Top of the Inflammatory Cascade Binds + Blocks RASP Reproxalap Modulation of downstream cascade Corticosteroids T-Cell Corticosteroids Cytokines Activation Cyclosporine Lifitegrast Downstream effects Pain Inflammation Heat Redness Swelling Sources: 1. Lee SJ, et al.
Slide 5: Study Design
Study Design Key eligibility criteria: TRANQUILITY Run-In Cohort Design • ≥18 years of age • History of DED for ≥6 months before screening Day 1 Day 2 • Corneal fluorescein staining sum ≥4 in at least one eye on Environmental Controlled Chamber the Ora Calibra® Scale at Visit 1 • Increase in dryness
Slide 6: Baseline Patient Characteristics
Baseline Patient Characteristics Reproxalap (n=12) Vehicle (n=11) Sex, n, (%) Female 9 (75.0) 8 (72.7) Male 3 (25.0) 3 (27.3) Median age in years (range) 65 (39–81) 66 (53–78) Age ≥65 years, n, (%) 7 (58.3) 7 (63.6) Ethnicity, n (%) White 10 (83.3) 10 (90.9) Black/African American 2 (16.7) 1 (9.1) N
Slide 7: Assessments at Day 1
Assessments at Day 1 TRANQUILITY Run-In Cohort Day 1 (24 Hours) Results:* Change from Baseline Dry Eye Assessment (Scale) p value after Environmental Dosing Reproxalap Vehicle (n=12) (n=11) VAS Dryness (0–100) -26 +2.6 0.01 OD4S: Discomfort (0–5) -0.7 +0.4 0.01 OD4S: Dryness (0–5) -1.2 +0.1 0.02 OD4
Slide 8: Symptoms and Signs in a Controlled Chamber
Day 2 Symptoms and Signs in a Controlled Chamber Ocular Dryness Score (VAS) Ocular Discomfort Scale (0–4) Ocular Redness Score (0–4) Reproxalap (n=12) Vehicle (n=11) Second Dose 60 3.5 1 Second Dose Second Dose 0.9 Mean Ocular Discomfort Score (0–4) Mean Ocular Redness Score (0–4) 3 50 0.8 VAS Dryne
Slide 9: Safety Overview from the TRANQUILITY Run-In Cohort
Safety Overview from the TRANQUILITY Run-In Cohort Reproxalap (n=12) Vehicle (n=11) Installation site warmth n (%) 1 (8) 0 Installation site discomfort n (%) 7 (58) 0 Adverse events (AEs) leading to discontinuation 0 0 Serious adverse events (SAEs) 0 0 • All AEs were mild and related to instillation
Slide 10: Summary and Conclusions
Summary and Conclusions • Reproxalap reduced ocular dryness and discomfort symptom scores relative to vehicle after one day in an environmental setting. • In the controlled chamber, reproxalap demonstrated acute and sustained improvements vs. vehicle in ocular dryness, discomfort, and redness. • Rep
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