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Aldeyra Therapeutics Announces First Quarter 2019 Financial Results and Provides Corporate Update
Reported Positive Results from Phase 3 ALLEVIATE Trial in Allergic Conjunctivitis
Initiated Adaptive Phase 3 RENEW Trial in Dry Eye Disease
Last Patient Dosed in Phase 3 SOLACE Trial in Noninfectious Anterior Uveitis
Completion of Part 1 of the Phase 3 RESET Trial in Sjögren-Larsson Syndrome Expected in Second Half of 2019
Initiation of Adaptive Phase 3 Clinical Trial in Proliferative Vitreoretinopathy Expected in Second Half of 2019
LEXINGTON, Mass., May 9, 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 quarter ended March 31, 2019 financial results and provided a corporate update.
With the announcement of positive results from the Phase 3 ALLEVIATE Trial, the initiation of the Phase 3 RENEW Trial, and the completion of dosing in the Phase 3 SOLACE Trial, our progress in 2019 has been remarkable, commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. We look forward to announcing results from the SOLACE Trial and completing Part 1 of the Phase 3 RESET Trial later this year, as we continue to advance our innovative pipeline towards commercialization across a variety of serious diseases.
Recent Highlights and Corporate Updates
Reported Positive Results from the Phase 3 ALLEVIATE Trial in Allergic Conjunctivitis. The double-masked, randomized, vehicle-controlled, multi-center, parallel-group conjunctival allergen challenge ALLEVIATE Trial assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solutions compared to vehicle in 318 patients with seasonal allergic conjunctivitis. The primary endpoint of ocular itch score area under the curve was achieved for both concentrations (p < 0.0001 and p = 0.0025, respectively). The key secondary endpoint of clinically relevant two-point ocular itch score improvement was also achieved for both concentrations (p = 0.0005 and p = 0.0169, respectively). 0.25% reproxalap is expected to advance to additional Phase 3 clinical testing contingent upon successful completion of ongoing environmental allergen exposure method development studies and subsequent discussion with regulatory authorities.
Initiated Adaptive Phase 3 RENEW Trial in Dry Eye Disease, and Presented Phase 2b Dry Eye Disease Clinical Trial Results at the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. In September 2018, and at ARVO in May 2019, Aldeyra reported results from topical ocular reproxalap in a Phase 2b dry eye disease
The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Thursday, May 9, 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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