Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (June 2022)
8 slides from Aldeyra Therapeutics's technical presentation, Jun 8, 2022
Slide 1: Top-Line Results from the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease
Aldeyra Top-Line Results from the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease June 8, 2022 NASDAQ: ALDX ©Aldeyra Therapeutics, Inc. 2022
Slide 2: Forward-looking statements
Aldeyra 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 Al
Slide 3: Previously Achieved Statistical Significance in Two Symptom and Two Sign Pivotal Trials
Aldeyra Previously Achieved Statistical Significance in Two Symptom and Two Sign Pivotal Trials† Aldeyra intends to submit two previously completed 12-week adequate and well-controlled symptom trials that prespecified patient-reported ocular dryness score as a primary endpoint or a co-primary endpoi
Slide 4: Schirmer Test Achieved in TRANQUILITY as Secondary Endpoint, Confirmed with Post-Hoc Responder Analysis
As a Secondary Endpoint, Schirmer Test Achieved in TRANQUILITY and Clinical Relevance Confirmed with Post-Hoc Responder Analysis Schirmer Test ≥10 mm Schirmer Test Responder Analysis Reproxalap (n=153) Vehicle (n=153) ≥ 10 mm increase in tear production post-Dose 4 on Day 1 31% 15% Odds ratio (95% c
Slide 5: Schirmer Test Designated as Primary Endpoint of TRANQUILITY-2
To Allow for Potential Submission of Two Dry Eye Disease Signs, Schirmer Test Designated as Primary Endpoint of TRANQUILITY-2 Design Multi-center, randomized, double-masked, parallel group, vehicle-controlled Dosing 0.25% reproxalap or vehicle Day 1: four doses Day 2: one dose before dry eye chamber
Slide 6: In TRANQUILITY-2, Both Primary Endpoints Were Achieved
Reproxalap (n=181) Vehicle (n=180) ≥ 10 mm increase in tear production post-Dose 4 on Day 1 25% 8% Odds ratio (95% confidence interval) ‡ 2.6 (1.7, 4.1) p-value‡ versus vehicle < 0.0001 Graph horizontal axis values offset for clarity; graph p value derived from mixed effect model of repeated measure
Slide 7: Clinical Efficacy Requirements for Dry Eye Disease NDA Submission Believed Met
Aldeyra believes that the clinical efficacy requirements for dry eye disease NDA submission have been met. • We intend to submit an NDA covering symptoms (ocular dryness) and three sign endpoints (ocular redness, Schirmer test, and Schirmer test responder proportions) across five adequate and well-c
Slide 8: Intends to Submit Symptom and Three Sign Endpoints for NDA Efficacy Requirements
Aldeyra Intends to Submit Symptom and Three Sign Endpoints for Satisfaction of Dry Eye Disease NDA Efficacy Requirements† Phase 2 Dry Eye Chamber Trial* Phase 3 RENEW–Part 1 Formulation Phase 2* p=0.03 p=0.009 Phase 3 TRANQUILITY Trial p=0.02 Schirmer Test Phase 3 TRANQUILITY Trial Phase 3 TRANQUILI
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