Gaithersburg-based Sigma-Tau Pharmaceuticals Inc. said Thursday it has won Food and Drug Administration approval for Cystaran, which treats a symptom of the rare genetic eye disease Cystinosis.
Cystaran, an FDA-designated orphan drug with seven years guaranteed market exclusivity, was co-developed with the National Institutes of Health. The drug treats the accumulation of crystals of the amino acid cystine in the cornea resulting from Cystinosis, a disease that affects an estimated 2,000 people worldwide, according to the Cystinosis Research Network.