Thygesons Superficial Punctate Keratopathy

Cyclosporine Ophthalmic Emulsion 0.05% – Restatis by Allergan

Produced as a sterile, preservative-free emulsion made from a white powder, Cyclosporine acts as a topical immunomodulator that has an anti-inflammatory effect.  While Cyclosporine is the active ingredient, there are a number of inactive ingredients including polysorbate 80, glycerin, carbomer copolymer type A, castor oil, purified water, and sodium hydroxide to adjust its pH level.

The exact way in which Cyclosporine works is not known.  It is thought to act as an immunomodulator that encourages tear formation in patients whose tear formation appears to be suppressed due to inflammation caused by an eye infection.

There is no detectable accumulation of the drug in human blood during 12 months of treatment, measured at less than 0.1 ng/mL.

Trials involving about 1,200 patients with moderate to severe keratoconjunctivitis sicca showed statistically significant improvement within six months.  There were no increased levels of bacterial or fungal infections reported during the clinical studies. Contraindications in patients were found where they had active ocular infections and in patients who were sensitive to any of the ingredients.  No studies have been carried out in patients with a history of herpes keratitis.

Restatis is available for ophthalmic use only and comes in single use vials that should be used as soon as opened to be administered to one or both eyes before the remaining medicine is disposed of.  To avoid contamination of the emulsion, the vial should not come into contact with the eye or skin.  If you wear contact lenses, these should be removed before treatment and left out for at least 15 minutes.

Animal tests found that there was some degree of systemic carcinogenicity and pancreatic islet cell adenomas in rats above the control level, which were not dose related.   However, the doses were 500-1000 times greater than that the daily human dose of one drop per eye (0.001mg/kg/day).  There has been no evidence to suggest that Cyclosporine is mutagenic or genotoxic, although an induction in sister chromatid exchange using human lymphocytes in vitro gave a positive result. No fertility impairment was found in studies of rats receiving 15,000 times the human daily dose. Oral doses in rats and rabbits up to 17mg/kg/day showed no embryofetal toxicity.  Restatis should not be prescribed to nursing women in case of Cyclosporine being excreted in breast milk.  Cyclosporine has not been tested for pediatric use.

There are some adverse reactions noted by using Cyclosporine including ocular burning, conjunctival hyperermia, epiphora, discharge, foreign body sensation, pruritus, eye pain, stinging, and blurring of vision.

Dosage is suggested as one drop twice a day in each eye approximately twelve hours apart.  It can be used alongside artificial tears as long as there is at least a 15 minutes interval between taking one product and another.  Once open, vials should be disposed of.  As Restatis is packaged in single use vials, each vial containing 0.4 mL, and is supplied in trays containing 30 vials. For a month supply, two trays of 30 vials are supplied.

Suggested Link:

Tags: , , , ,

Leave a Reply

Information, Advice, and eForum on Thygesons SPK, Thygesons Superficial Punctate Keratitis, TSPK ,Thygesons Superficial Punctate Keratopathy Thygesons Disease, or Thygesons Syndrome