Sigma-Tau Pharmaceuticals, Inc. announced today that the Company has received approval from the U.S. Food & Drug Administration (“FDA”) for CYSTARAN™ (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the National Institutes of Health (“NIH”), for the treatment of patients suffering from corneal cystine crystal accumulation as a result of cystinosis. CYSTARAN™ is designated an Orphan Drug in the U.S., and has been granted seven years of market exclusivity.
Cysteamine is a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis. However, when orally administered, cysteamine does not reach the cornea and is therefore ineffective in reducing the ocular effects of cystinosis. CYSTARAN™ is for topical ophthalmic use and is indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. As a result, CYSTARAN™ now represents the only FDA-approved ophthalmic treatment for this condition.
“As a Company dedicated to the development and commercialization of novel therapies that address the unmet medical needs of a wide range of rare disease patients, we are delighted to announce the approval of CYSTARAN™,” noted Dave Lemus, Chief Operating Officer of Sigma-Tau. “This new medicine will offer physicians the only FDA-approved treatment for patients with corneal cystine crystal accumulation, many of whom are children and whose lives are seriously impacted by this debilitating chronic condition.”