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ab aldeyra Aldeyra Therapeutics Reports First - Quarter 2021 Financial Results and Recent Business Highlights May 6 , 2021 • Recently Announced Phase 3 INVIGORATE Clinical Trial Results Indicated Statistically Significant Activity of Reproxalap in Ocular Itching and Redness Associated with Allergic Conjunctivitis • Top - Line Results from Phase 3 TRANQUILITY and TRANQUILITY - 2 Trials of Reproxalap in Dry Eye Disease Expected in the Second Half of 2021 • Initial Phase 2 Clinical Trial Results for ADX - 629 , a Novel Orally Available Systems - Based RASP Inhibitor with Potential Broad Applicability Across Immune - Mediated Diseases , Expected in the Second Half of 2021 • Raised Gross Proceeds of $ 125 Million Before Deduction of Underwriting Discounts and Commissions , in Underwritten Public Offering • Projected Cash Runway Through 2023 , Including Potential New Drug Applications ; Initial Commercialization of Reproxalap , if Approved ; and Continued Pipeline Development • Management to Host Conference Call at 8:00 a.m. ET Today LEXINGTON , Mass .-- ( BUSINESS WIRE ) -- May 6 , 2021-- Aldeyra Therapeutics , Inc. ( Nasdaq : ALDX ) ( Aldeyra ) , a clinical - stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune - mediated diseases , today reported financial results for the quarter ended March 31 , 2021 and provided recent business highlights . " We expect 2021 to be a catalyst - rich year for Aldeyra as we continue to advance reproxalap , our lead program , toward potential commercialization in anterior ocular inflammatory disease , " stated President and CEO Todd C. Brady , M.D. , Ph.D. " We recently completed the Phase 3 INVIGORATE Trial of reproxalap , achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis , including ocular itching and redness . We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application ( NDA ) . In addition , we remain on track to report top - line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY - 2 clinical trials of reproxalap in dry eye disease . " We believe we continue to operate from a position of financial strength , " Dr. Brady stated . " With the recent follow - on public offering , we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch , if approved , while investing in the clinical development of ADX - 629 , ADX - 2191 , and other product candidates in retinal and systemic immunological diseases with unmet medical need . " Recent Highlights and Program Updates • Primary , Key Secondary , and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial : In the first - ever Phase 3 clinical trial of a novel investigational product in an allergen chamber , 0.25 % reproxalap ophthalmic solution ( reproxalap ) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching ( p < 0.0001 ) , the key secondary endpoint of ocular redness ( p < 0.0001 ) , and the secondary endpoints of ocular tearing and total ocular severity score ( each p < 0.0001 ) . The results of INVIGORATE , the second positive Phase 3 trial for reproxalap in allergic conjunctivitis , indicate potential clinical utility before and during exposure to moderate to high levels of pollen . • Phase 3 TRANQUILITY and TRANQUILITY - 2 Dry Eye Disease Trial Results Expected in Second Half of 2021 : Patient enrollment has begun in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap . The primary endpoint of the trial is ocular redness , which was statistically lower ( p = 0.03 ) for reproxalap relative to vehicle in the TRANQUILITY run - in cohort results announced in January 2021. Tear RASP ( reactive aldehyde species ) levels will also be assessed . Approximately 150 dry eye disease patients are expected to be enrolled per arm . Reproxalap will be administered four times the day prior to entry into the dry eye chamber , just before entry into the chamber , and 45 minutes after chamber entry . Enrollment in TRANQUILITY is ongoing , and enrollment in the confirmatory TRANQUILITY - 2 Trial is expected to begin in the second quarter of 2021. Aldeyra plans to report top - line results from both trials in the second half of this year . • Phase 2 Clinical Trial Results from ADX - 629 , an Orally Available RASP Inhibitor , Expected Second Half of 2021 : Initial Phase 2 clinical results from ADX - 629 , a novel orally available RASP inhibitor currently undergoing testing in asthma , psoriasis , and COVID - 19 , are expected in the second half of 2021. ADX - 629 represents a first - in - class systems - based therapeutic approach for an orally administered RASP inhibitor , the potential applicability of which could extend to a myriad of immune - mediated diseases that today are treated with single - target drugs that can lead to serious toxicity . • Public Offering Completed : Aldeyra sold 10,000,000 shares of its common stock at a public offering price of $ 12.50 per share in an underwritten public offering . The offering generated gross proceeds of $ 125.0 million and net proceeds of $ 117.3 million after deducting underwriting discounts , commissions , and estimated offering expenses .