Cysteamine for corneal cystine crystal accumulation available

Gaithersburg, MD-Sigma-Tau Pharmaceuticals Inc. has launched cysteamine ophthalmic solution 0.44% (Cystaran), the first and only FDA-approved therapy for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Sigma-Tau developed cysteamine in partnership with the National Institutes of Health and in cooperation with the Cystinosis Foundation, the Cystinosis Research Foundation, and the Cystinosis Research Network. The FDA approved cysteamine in October 2012, and the product has also been granted orphan drug status.

In connection with its product launch, Sigma-Tau has established a hotline, staffed by pharmacists, registered nurses, and specialists trained to coordinate the delivery of the drug to patients, provide reimbursement support, and offer pharmacy services.

“The [cysteamine] launch marks an important milestone for Sigma-Tau and further demonstrates our proven ability to develop and deliver novel therapies for patients suffering from a wide range of rare diseases,” said Dave Lemus, chief executive officer of Sigma-Tau. “Sigma-Tau is committed to ensuring comprehensive access for all cystinosis patients with corneal crystal accumulation, and we feel especially privileged to be able to offer this critical new therapy, which will make a positive impact on these patients’ daily lives.”

The drug is available as a sterile ophthalmic solution containing 6.5 mg/ml of cysteamine hydrochloride equivalent to 4.4 mg/ml of cysteamine 0.44%. For full prescribing information for cysteamine, see www.cystaran.com.

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