CYSTARAN (cysteamine ophthalmic solution) 0.44%

CYSTARAN (cysteamine ophthalmic solution) 0.44% is indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

CYSTARAN is the only FDA approved eye drop available for treatment of corneal cystine crystals in patients with cystinosis.

Cystinosis is a genetic disease that causes an abnormally large accumulation of the amino acid, cystine, to form as crystals in the patient’s major organs. Buildup of cystine crystals in the kidneys, eyes, liver, muscles, pancreas, brain and white blood cells slowly devastates the organs, eventually leading to kidney failure or end-stage renal disease.

Oral cysteamine has been approved by the U.S. Food and Drug Administration (FDA) for the management of nephropathic cystinosis in children and adults. Cysteamine is a cystine-depleting agent that lowers cystine levels within the cells. Early diagnosis and cysteamine treatment have proven effective in delaying renal failure and has greatly contributed to the prognosis of those born with cystinosis.

However, oral cysteamine has no impact on the formation of crystals in the patient’s eyes. Ocular complications associated with deposition of corneal cystine crystals include photophobia, eye pain, squinting, corneal haziness and foreign body sensations. In some cases, the cystine crystal accumulation becomes so severe that the crystals can damage the cornea, resulting in serious vision difficulties.

With approximately 300 cystinosis patients with cystinosis in the U.S., CYSTARAN was granted an Orphan Drug Designation.

Clinical safety and efficacy of CYSTARAN were previously evaluated in controlled clinical trials conducted by the NIH, in approximately 300 patients. Results of the studies support the use of ophthalmic cysteamine as an effective treatment of corneal cystine crystals. The most frequently reported ocular adverse reactions, occurring in ≥ 10% of patients, were sensitivity to light, redness, eye pain/irritation, headache and visual field defects.

CYSTARAN is planned to be available in the future through specialty pharmacy distribution channels.

Click here for full prescribing information for CYSTARAN.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Click here for contact information.