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ab aldeyra Aldeyra Therapeutics Reports Second - Quarter 2021 Financial Results and Recent Corporate Highlights August 5 , 2021 • Top - Line Results from Phase 3 TRANQUILITY and TRANQUILITY - 2 Clinical Trials of Reproxalap in Dry Eye Disease Expected in Fourth Quarter of 2021 • U.S. FDA Grants Orphan Drug Designation to ADX - 2191 for the Treatment of Primary Vitreoretinal Lymphoma and Retinitis Pigmentosa • Initial Results from Phase 2 Clinical Trials of Oral RASP Inhibitor ADX - 629 in Multiple Systemic Indications Anticipated in Fourth Quarter of 2021 or First Quarter of 2022 • Cash and Cash Equivalents of $ 249.7 Million as of June 30 , 2021 ; Projected Cash Runway Through 2023 , Including Potential New Drug Applications ; Initial Commercialization of Reproxalap , if Approved ; and Continued Development of Compounds for Retinal and Systemic Diseases • Management to Host Conference Call at 8:00 a.m. ET Today LEXINGTON , Mass .-- ( BUSINESS WIRE ) -- Aug . 5 , 2021-- Aldeyra Therapeutics , Inc. ( Nasdaq : ALDX ) ( Aldeyra ) , a biotechnology company developing novel immune - modulating therapies to treat ocular and systemic diseases , today reported financial results for the quarter ended June 30 , 2021 and recent corporate highlights . " We continue to make meaningful strides toward our goal of developing effective and highly differentiated new therapies to treat ocular and systemic diseases with significant unmet medical need , " stated Todd C. Brady , M.D. , Ph.D. , President and Chief Executive Officer of Aldeyra . " We remain on schedule to report top - line results from the Phase 3 TRANQUILITY and TRANQUILITY - 2 dry eye disease clinical trials in the fourth quarter of this year , and we look forward to releasing results of our Phase 2 clinical trials of ADX - 629 in systemic immunological diseases by the end of the year or early 2022. " Recent Corporate Highlights and Program Updates • Phase 3 TRANQUILITY and TRANQUILITY - 2 Dry Eye Disease Clinical Trial Results Expected in the Fourth Quarter of 2021 : Enrollment is ongoing in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap . An identical trial , TRANQUILITY - 2 , is expected to begin enrollment this quarter . Ocular redness is the primary endpoint of the TRANQUILITY trials , which include tear RASP levels , Schirmer's test , and dry - eye symptoms as secondary endpoints . Top - line results are expected in the fourth quarter of this year . In addition , the company has initiated a multi - center , double - masked , randomized , vehicle - controlled , parallel - group Phase 2 clinical trial of reproxalap in dry eye disease . The Phase 2 trial is designed to optimize the measurement of tear RASP levels , with approximately 75 patients expected to be enrolled per arm . Similar to TRANQUILITY , ocular redness is the primary endpoint in the trial . • Orphan Drug Designation Granted for ADX - 2191 in Two Additional Retinal Disease Indications : The U.S. Food and Drug Administration ( FDA ) granted orphan drug designation to ADX - 2191 ( methotrexate for intravitreal injection ) for the treatment of two rare retinal diseases : primary vitreoretinal lymphoma , an aggressive , high - grade cancer ; and retinitis pigmentosa ( RP ) , a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision . Aldeyra plans to initiate a Phase 2 clinical trial of ADX - 2191 in patients with RP this year . The FDA's orphan drug designation program is designed to provide financial incentives to sponsors for developing drugs and biologics for rare diseases and conditions , in part defined as affecting fewer than 200,000 people in the United States . Sponsors of designated orphan drugs are eligible for partial tax credits for clinical trial costs , waiver of the user fee for marketing applications and , upon approval , consideration for seven years of marketing exclusivity . • Phase 2 Clinical Trial Results from ADX - 629 , an Orally Available , Systems - Based RASP Inhibitor , Expected in the Fourth Quarter of 2021 or First Quarter of 2022 : Initial Phase 2 clinical trial results from ADX - 629 , a novel orally available RASP inhibitor currently undergoing testing in asthma , psoriasis , and COVID - 19 , are expected in the fourth quarter of 2021 or first quarter of 2022. ADX - 629 represents a first - in - class systems - based therapeutic approach for the potential treatment of a myriad of immune - mediated diseases that today are treated with single - target drugs that can lead to serious toxicity . Second - Quarter 2021 Financial Results Cash and cash equivalents as of June 30 , 2021 were $ 249.7 million . Based on Aldeyra's current operating plan , the company believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023 , including potential New Drug Application submissions for reproxalap ; initial commercialization of reproxalap , if approved ; and continued development of the company's product