Exhibit 99.1

 

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Aldeyra Therapeutics Reports Full Year 2016 Financial Results

Lexington, MA, March 30, 2017 – Aldeyra Therapeutics, Inc. (Nasdaq:ALDX) (Aldeyra), a biotechnology company focused primarily on the development of new products for inflammation, inborn errors of metabolism, and other diseases that are thought to be related to endogenously generated toxic and pro-inflammatory chemical species known as aldehydes, today announced its financial results for the year ended December 31, 2016.

“2016 was a productive year for Aldeyra, highlighted by positive data from our late-stage clinical programs in allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson Syndrome,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We look forward to building upon our accomplishments from last year as we advance our clinical programs, two of which are expected to commence Phase 3 studies in 2017. In addition, we expect to initiate a new clinical program in Dry Eye Syndrome.”

Key 2016 Clinical Program Highlights and Upcoming Events

 

    Topical Dermatologic ADX-102 in Sjögren-Larsson Syndrome. In August 2016, Aldeyra announced positive results from a randomized, double-blind, vehicle-controlled Phase 2 clinical trial of ADX-102 in SLS patients. ADX-102 was statistically superior to vehicle and demonstrated clinically relevant activity in diminishing the severity of ichthyosis, a serious dermatologic disease that afflicts patients with Sjögren-Larsson Syndrome. Following an End of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA), Aldeyra expects to initiate enrollment of a Phase 3 trial in the second half of 2017.

 

    Topical Ocular ADX-102 in Noninfectious Anterior Uveitis. In May 2016, Aldeyra announced positive results from a randomized, parallel-group, investigator-masked, active-controlled Phase 2 clinical trial of ADX-102 in noninfectious anterior uveitis patients. ADX-102 reduced inflammatory cell count in the anterior chamber of the eye to a degree similar to that of standard-of-care corticosteroid therapy (which may lead to cataracts and glaucoma in some patients), but without the intraocular pressure elevations that were observed in subjects treated with corticosteroids. Following meetings held with the FDA, Aldeyra expects to initiate a vehicle-controlled Phase 3 clinical trial in the second quarter of 2017.

 

    Topical Ocular ADX-102 in Allergic Conjunctivitis. In February 2016, Aldeyra announced positive results from a randomized, parallel-group, double-masked, vehicle-controlled Phase 2a clinical trial of ADX-102 in allergic conjunctivitis patients. ADX-102 demonstrated statistically and clinically significant activity over vehicle in reducing ocular itching and tearing. Following a meeting held with the FDA, Aldeyra initiated enrollment in February 2017 of a saline-controlled Phase 2b clinical trial. Results from the trial are expected to be reported in the second half of 2017.

 

   

Topical Ocular ADX-102 and Topical Ocular ADX-103 in Dry Eye Syndrome. In November 2016, Aldeyra announced the addition of a Phase 2a clinical program in Dry Eye Syndrome, a common and painful ocular disease caused by inflammation and insufficient lipids (fats) in tears.


The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Thursday, March 30, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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