Exhibit 99.1

 

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Aldeyra Therapeutics Provides Corporate Update and Announces First Quarter 2017 Financial Results

Significant Platform Advancement Across Four Clinical Programs

Details Provided on 2017 and 2018 Catalysts

Lexington, MA, May 15, 2017 – Aldeyra Therapeutics, Inc. (Nasdaq:ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to aldehydes, today provided a corporate update and announced its financial results for the quarter ended March 31, 2017.

“We are pleased to update our progress with four clinical programs, three of which are now in late-stage development,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We expect results from our Phase 2b clinical trial in allergic conjunctivitis in June of this year, results from our Phase 2a clinical trial in Dry Eye Syndrome in the third quarter of this year, results from our Phase 3 clinical trial in noninfectious anterior uveitis in the second half of next year, and initial top-line data from our Phase 3 clinical trial in Sjögren-Larsson Syndrome in the second half of next year. With the initiation of a Phase 3 clinical trial in noninfectious anterior uveitis, the advancement of our clinical pipeline across four clinical indications - coupled with the receipt of orphan designation for ichthyosis - highlights the productivity achieved in the first quarter.”

Corporate Updates:

 

    Expected Timing of Results of Phase 2b Allergic Conjunctivitis Clinical Trial Ahead of Previous Guidance. In April 2017, Aldeyra announced the completion of enrollment and dosing in a Phase 2b clinical trial of topical ocular ADX-102 in allergic conjunctivitis. The trial tested 0.1% and 0.5% concentrations of topical ocular ADX-102 against saline. Each of the three groups in the trial was comprised of 50 patients with a history of allergic conjunctivitis. Consistent with clinical trials used for registration of other drugs in allergic conjunctivitis, patients in the Phase 2b trial were treated with a single dose of drug or control solution in both eyes, followed by topically administered allergens. Patient-reported ocular itching will be assessed as the primary endpoint. Results from the trial are expected to be announced in June 2017.

 

    Data Timeline for Phase 2a Clinical Trial in Dry Eye Syndrome Updated to Third Quarter of 2017. The Phase 2a clinical trial in Dry Eye Syndrome will test three formulations of topical ocular ADX-102 over 28 days of dosing. Endpoints will include standard signs and symptoms characteristic of Dry Eye Syndrome. Results of the clinical trial are expected to be announced in the third quarter of 2017.

 

    Phase 3 Clinical Trial in Noninfectious Anterior Uveitis Initiated in April 2017, Consistent with Previous Guidance. The Phase 3 noninfectious anterior uveitis clinical trial is expected to enroll up to 100 patients with active disease, randomized equally to receive either 0.5% topical ocular ADX-102 or vehicle for four weeks. The primary endpoint will be the resolution of inflammation. Results of the trial are expected to be announced in the second half of 2018.


The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Monday, May 15, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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