Generic Name: cysteamine ophthalmic solution
Date of Approval: October 2, 2012
Company: Sigma-Tau Pharmaceuticals, Inc.
Treatment for: Corneal Cystine Crystal Accumulation Due to Cystinosis
FDA Approves Cystaran
The U.S. Food & Drug Administration (FDA) has approved Cystaran (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic 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.
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.
The clinical safety and efficacy of Cystaran was previously evaluated in controlled clinical trials conducted by the NIH, in approximately 300 patients. Results of these 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.
Highlights of Prescribing Information
These highlights do not include all the information needed to use Cystaran safely and effectively. See full prescribing information for Cystaran.
Indications and Usage
Cystaran is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Dosage and Administration
Instill one drop of Cystaran in each eye, every waking hour.
Dosage Forms and Strengths
Sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride equivalent to 4.4 mg/mL of cysteamine (0.44%).
Warnings and Precautions
To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.
Cystaran side effects
The most common adverse reactions (incidence approximately 10% or greater) are sensitivity to light, redness, eye pain/irritation, headache and visual field defects.
See also: Cystaran side effects (in more detail)
Patient Counseling Information
Storage of Bottles
- Patients should be advised to store bottles in the freezer in the original carton.
- Each week, one new bottle should be removed from the freezer.
- Patients should be advised to allow the bottle to thaw completely (approximately 24 hours) prior to use.
- After the bottle is completely thawed, the patient should record the discard date on the bottle label. The discard date is seven (7) days from the day the bottle is thawed.
- Patients should be advised to store thawed bottle at 2°C to 25°C (36°F to 77°F) for up to 1 week. The thawed bottles should not be refrozen.
- At the end of 1 week (7 days), patients should discard the bottle. There may be medication left in the bottle; however, the bottle must be discarded by the patient because the medication is only stable for 1 week after thawing.
Risk of Contamination
Patients should be advised not to touch the eyelid or surrounding areas with the dropper tip of the bottle. The cap should remain on the bottle when not in use.
Use with Contact Lenses
Patients should be advised that contact lenses should be removed prior to application of Cystaran. Contact lenses may be reinserted 15 minutes following Cystaran administration.
Topical Ophthalmic Use Only
Patients should be advised that Cystaran is for topical ophthalmic use only.