Exhibit 99.1

Aldeyra Therapeutics Announces Year-End 2018 Financial Results

 

   

Results from the ALLEVIATE Phase 3 Clinical Trial in Allergic Conjunctivitis Expected in Early 2019

   

The RENEW Adaptive Phase 3 Clinical Trial in Dry Eye Disease Expected to Begin in First Half of 2019

   

Results from the SOLACE Phase 3 Clinical Trial in Noninfectious Anterior Uveitis Expected in Second Half of 2019

   

Results from Part 1 of the RESET Phase 3 Clinical Trial in Sjögren-Larsson Syndrome Expected in Second Half of 2019

   

Adaptive Phase 3 Clinical Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected to Begin in Second Half of 2019

   

Operations Expected to be Funded Through 2020

LEXINGTON, Mass., March 8, 2019 /PRNewswire/ -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced year ended December 31, 2018 financial results.

“2018 was a landmark year for Aldeyra, highlighted by positive results from our Phase 2b dry eye disease clinical trial, and the subsequent acquisition of Helio Vision in January of this year,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We were pleased to add new Phase 3 clinical programs in dry eye disease and proliferative vitreoretinopathy, complementing our Phase 3 trials in allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson Syndrome. We look forward to updating investors on the progress of our late-stage development pipeline throughout 2019, as we continue our efforts to bring novel therapeutic options to market.”

Recent Highlights and Corporate Updates

   

Retinal Disease Pipeline Expanded with Acquisition of Helio Vision. The acquisition of Helio Vision in January 2019 broadened Aldeyra’s development program in retinal disease with a Phase 3-ready product candidate, ADX-2191, for proliferative vitreoretinopathy (PVR). PVR, a rare inflammatory fibroproliferative disorder with no approved treatment, leads to severe retinal scarring and blindness. ADX-2191 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the prevention of PVR. Following discussions with regulatory authorities, Aldeyra plans to initiate an adaptive Phase 3 clinical trial in PVR during the second half of 2019.

 

   

Positive Results Achieved in Dry Eye Disease Phase 2b Clinical Trial. In September 2018, Aldeyra announced that 0.25% topical ocular reproxalap demonstrated statistical superiority over vehicle across multiple dry eye disease symptoms and signs. Based on the positive Phase 2b clinical results, in the first half of 2019, Aldeyra plans to initiate Part 1 of the RENEW adaptive Phase 3 clinical trial of 0.25% topical ocular reproxalap in patients with dry eye disease.

 

   

Results Expected from the ALLEVIATE Phase 3 Clinical Trial in Allergic Conjunctivitis in Early 2019. The ALLEVIATE trial is a multi-center, double-masked, parallel-group, vehicle-


The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Friday, March 8, 2019 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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