Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (December 2021)
9 slides from Aldeyra Therapeutics's corporate update, Dec 21, 2021
Slide 1: Top-Line Results from the Phase 3 TRANQUILITY Trial in Dry Eye Disease
Exhibit 99.1 December 20, 2021 Top-Line Results from the Phase 3 TRANQUILITY Trial in Dry Eye Disease
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: The FDA Requires Two Positive Symptom Trials and Two Positive Sign Trials
The FDA Requires Two Positive Symptom Trials and Two Positive Sign † Trials to Satisfy Efficacy Requirements for Dry Eye Disease • Aldeyra intends to submit two previously completed 12- week adequate and well- controlled symptom trials that pre-specified patient-reported ocular dryness score as a pr
Slide 4: TRANQUILITY Trial Design
TRANQUILITY Dry Eye Disease Trial Design 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, one dose in chamber Size 153 patients per arm (306 total) Ocular redness over 90 mi
Slide 5: TRANQUILITY Missed Primary Endpoint, but Schirmer Test Secondary Endpoint Achieved
TRANQUILITY Missed Primary Endpoint, but Schirmer Test Secondary Endpoint Achieved (p=0.0001) and Represents an Approvable Sign Ocular Redness Schirmer Test MMRM = mixed effect model of repeated measures. Estimates reflect change from baseline. Schirmer test performed on Day 1 after the first, secon
Slide 6: Clinical Relevance of Schirmer Test Results Confirmed with Post-Hoc Responder Analysis
Clinical Relevance of Schirmer Test Results Confirmed with Post-Hoc Responder Analysis of ≥10mm Improvement from Baseline Responder Reproxalap Vehicle Analysis (n=153) (n=153) ≥10mm increase in tear production on 21% 11% Day 1 Odds ratio (95% 2.6 (1.7, 4.1) ‡ confidence interval) ‡ p-value versus <
Slide 7: Ocular Dryness and Itching Symptom Improvement Approached Statistical Significance
Despite Lack of Powering for Secondary Endpoints, Ocular Dryness and Itching Symptom Improvement Approached Statistical Significance Over a Single Day of Dosing Ocular Dryness Symptom Score Ocular Itching Symptom Score MMRM = mixed effect model of repeated measures. SEM = standard error of the mean.
Slide 8: TRANQUILITY-2 Trial Design
TRANQUILITY-2 Trial Design • Target enrollment for TRANQUILITY-2 Multi-center, randomized, double-masked, Design increased to up to 400 patients; top- parallel group, vehicle-controlled line results expected mid-2022. 0.25% reproxalap or vehicle • Using an alpha sharing approach, Dosing Day 1: four
Slide 9: Anticipated Mid-2022 Top-Line Results from TRANQUILITY-2 Not Expected to Affect NDA Timing
Anticipated Mid-2022 Top-Line Results from TRANQUILITY-2 Are Not Expected to Affect Timing of Dry Eye Disease NDA Submission • Assuming success in TRANQUILITY-2, enrollment in the 12-month safety trial remains the gating factor for dry eye disease NDA submission, which is expected in mid- 2022. • Th
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