Exhibit 99.1 December 20, 2021 Top-Line Results from the Phase 3 TRANQUILITY Trial in Dry Eye Disease
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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 primary endpoint. • Either ocular redness or Schirmer test qualifies as a dry eye disease sign. • Adequate and well-controlled Phase 2 or Phase 3 clinical trials can be submitted as pivotal. † Draft U.S. Food and Drug Administration (FDA) guidance MMRM = mixed effect model of repeated measures. SEM = standard error of the mean. Topical ocular reproxalap has been studied in more than 1,500 patients with no observed safety concerns; mild and transient instillation site discomfort is the most commonly reported adverse event in clinical trials. 3
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 minutes in dry eye chamber Primary Endpoint Secondary • Schirmer test on Day 1 Endpoints• Dry eye disease symptoms 4
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, second, and fourth doses of test article for Phase 2, Phase 3 TRANQUILITY run-in, and Phase 3 TRANQUILITY clinical trials, respectively. Topical ocular reproxalap has been studied in more than 1,500 patients with no observed safety concerns; mild and transient instillation site discomfort is the most commonly reported adverse event in clinical trials. 5
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 < 0.0001 vehicle ‡ Generalized estimating equation analysis controlling for baseline, pre/post dose, and site. MMRM = mixed effect model of repeated measures. SEM = standard error of the mean. mm = millimeter. Schirmer test administered before and after fourth dose on Day 1. Graph horizontal axis values offset for clarity. Topical ocular reproxalap has been studied in more than 1,500 patients with no observed safety concerns; mild and transient instillation site discomfort is the most commonly reported adverse event in clinical trials. 6
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. Graph horizontal axis values offset for clarity. Subjects received three doses before 4 hours post-baseline, another dose approximately 5 hours post-baseline, and were reassessed 24 hours after baseline. Topical ocular reproxalap has been studied in more than 1,500 patients with no observed safety concerns; mild and transient instillation site discomfort is the most commonly reported adverse event in clinical trials. 7
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 doses TRANQUILITY‐2 expected to be Day 2: one dose before dry eye chamber, one submitted as pivotal for either ocular dose in chamber redness or Schirmer test if primary endpoint is met. Size Up to 200 patients per arm • Based on data from Phase 2 and Ocular redness over 90 minutes in dry eye Primary Endpoint TRANQUILITY clinical trials, powering chamber or Schirmer test on Day 1 simulations indicate more than 90% of outcomes achieved for either Secondary Endpoints Dry eye disease symptoms on Day 1 ocular redness or Schirmer test endpoints. 8
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. • The allergic conjunctivitis NDA is expected to be submitted subsequent to the dry eye disease NDA and, as requested by the FDA, following completion of additional allergen chamber trial, if successful. NDA = New Drug Application. MMRM = mixed effect model of repeated measures. Topical ocular reproxalap has been studied in more than 1,500 patients with no observed safety concerns; mild and transient instillation site discomfort is the most commonly reported adverse event in clinical trials. 9