Aldeyra Therapeutics Provides Update on NS2 Clinical Program

Aldeyra Therapeutics, Inc. ALDX (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today provided an update on its planned clinical trial programs in noninfectious anterior uveitis and Sjögren-Larsson Syndrome, as part of its webcast presentation at the Cowen and Company 35th Annual Healthcare Conference on Monday, March 2, 2015 at 4:50 p.m. ET. Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, "As we work to finalize the clinical trial protocol in both noninfectious anterior uveitis and Sjögren-Larsson Syndrome, we have remained in close contact with the FDA. Based on their requirements, we have amended and submitted an updated trial protocol for noninfectious anterior uveitis with regard to the severity of patients and the frequency of dosing. We believe that the updated protocol will satisfy these requirements and, pending FDA and IRB review, we remain on track to generate data from both of our clinical programs in 2015." The U.S. Food and Drug Administration (FDA) has notified Aldeyra that, before initiation of Aldeyra's planned Phase II clinical study of NS2 in patients with noninfectious anterior uveitis, the protocol submitted as part of the company's Investigational New Drug Application requires amending. Aldeyra has submitted an amended protocol that the Company believes will be acceptable to the FDA. Specifically, in the amended protocol, a minority subset of the most severe uveitis patients are excluded from enrollment, and the frequency of dosing was reduced to treat less severe disease and match the dosing frequency employed in the Phase I study. Consistent with earlier guidance, and subject to FDA review of the modified protocol, the trial is expected to begin enrollment in the first half of 2015, with preliminary data available by the end of the year. The company's Phase II clinical trial of a dermatologic formulation of NS2 to treat ichthyosis and other skin manifestations of Sjögren-Larsson Syndrome is expected to begin enrollment pending final Institutional Review Board (IRB) approval. Consistent with earlier guidance, final data from the trial are expected in the second half of 2015. NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping free aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate pathologic inflammation and address other diseases where aldehydes are thought to mediate pathology. To access the webcast of Aldeyra's presentation, please visit the Investors section of the Company's website at www.aldeyra.com. An archived version of the webcast will be available for 14 days following the presentation.