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Aldeyra Therapeutics submits FDA IND filing for noninfectious anterior uveitis

Aldeyra Therapeutics, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, 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.

NS2, 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 Sjogren-Larsson Syndrome (SLS), a rare disease caused by mutations in an enzyme that metabolizes fatty aldehydes.