Sigma-Tau gains US FDA approval for orphan eye drug Cystaran
The US subsidiary of privately-owned Italian drugmaker Sigma-Tau says it has received approval from the Food and Drug Administration for Cystaran (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the USA’s National Institutes of Health, for the treatment of patients suffering from corneal cystine crystal accumulation as a result of cystinosis.
Cystaran is designated an Orphan Drug in the USA and has been granted seven years of market exclusivity. The company plans to make the product available in the future through specialty pharmacy distribution channels.
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.
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