Full Press Release Details
Aldeyra Therapeutics Submits FDA IND Filing for Noninfectious Anterior Uveitis
Lexington, MA, December 18, 2014 Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of
products to treat diseases related to free aldehydes, today announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United
States Food and Drug Administration (FDA) on December 16, 2014.
Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, The
submission of an IND for NS2 in the treatment of noninfectious anterior uveitis is a major milestone for Aldeyra and is another step forward in the execution of our development strategy. NS2 has the potential to reduce or eliminate the use of
steroids in the treatment of this disease, which we believe would significantly enhance the treatment options for these patients and improve their long-term ocular health. We remain focused on advancing NS2 through its planned clinical program as we
prepare to initiate the Phase 2 trial early next year.
Noninfectious anterior uveitis is a rare disease that affects an estimated 25,000 patients
per year in the United States. Aldeyra has developed an ophthalmic formulation of its lead product candidate, NS2, to treat this disease and intends to initiate a Phase 2 trial for this indication in 2015, pending FDA review of the IND.
Noninfectious anterior uveitis is characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia. High levels of pro-inflammatory free aldehydes are associated with this and other ocular and systemic diseases. By
trapping free aldehydes, NS2 may reduce inflammation, fibrosis and tissue damage associated with inflammatory ocular diseases. Furthermore, there is a need for safe and effective alternatives to corticosteroids for noninfectious anterior uveitis and
other forms of ocular inflammation.
a product candidate that is designed to trap free aldehydes, is under development for the treatment of noninfectious anterior uveitis, a rare disease characterized by severe inflammation and pain in the anterior eye and Sj gren-Larsson Syndrome
(SLS), a rare disease caused by mutations in an enzyme that metabolizes fatty aldehydes.
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc., is a biotechnology company focused primarily on the development of products to treat diseases thought to be related to endogenous
free aldehydes, a naturally occurring class of toxic molecules. The company has developed NS2, a product candidate designed to trap free aldehydes. Aldeyra plans to initiate a Phase II clinical study of NS2 in noninfectious anterior uveitis in early
2015 and file an Investigational New Drug application in 2014 for clinical testing of NS2 in Sj gren-Larsson Syndrome. NS2 has not been approved for sale in the U.S. or elsewhere. www.aldeyra.com
Safe Harbor Statement
This release contains
forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra s plans for its product candidates. In some cases, you can identify
forward-looking statements by terms such as may, might, will, objective, intend, should, could, can, would, expect,
believe, anticipate, project, target, design, estimate, predict, potential, aim, plan or the negative of these terms, and similar
expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of
development and may not ever have any products that
generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Aldeyra s forward-looking statements include, among others, the
timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra s product
candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra s product candidates; the size and growth of the potential markets for Aldeyra s product candidates
and the ability to serve those markets; Aldeyra s expectations regarding Aldeyra s expenses and revenue, the sufficiency of Aldeyra s cash resources and needs for additional financing; Aldeyra s ability to attract or retain key
personnel; and other factors that are described in the Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations sections of Aldeyra s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2014 which is on file with the Securities and Exchange Commission (SEC) and available on the SEC s website at www.sec.gov.
In addition to the risks described above and in Aldeyra s other filings with the SEC, other unknown or unpredictable factors also could affect
Aldeyra s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes
no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 Ext. 205
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