Pharmaceutical-Approval Update: Cyclosporine Ophthalmic Emulsion, 0.05% (Restasis™)

21 Jun
2010

Approval UpdateManufacturer: Allergan, Inc., Irvine, CA Indication: Treatment of keratoconjunctivitis sicca (chronic dry eye disease, or CDED) in patients whose tear production is suppressed because of eye inflammation Drug Class: This ophthalmic emulsion contains a topical immunomodulator with anti-inflammatory activity. Uniqueness of Drug: Cyclosporine ophthalmic emulsion increases tear production in patients with dry eyes who do not produce enough tears. Although the exact mechanism of action is not known, it is thought that the emulsion works in two ways:

  • as a partial immunomodulator that produces a “T-cell effect,” which inhibits T cells from going into “battle mode” to protect the eyes from an outside attack
  • as an anti-inflammatory agent that prevents T cells from releasing cytokines, proteins that initiate the inflammatory effect of chronic dry eyes

Warnings: Cyclosporine ophthalmic emulsion has not been studied in patients with a history of herpes keratitis. Precautions: The product is for ophthalmic use only. The most common adverse effect is ocular burning (17%); other adverse events reported in 1% to 5% of patients have included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbances (usually blurring). canada pharmacy mall

Dosage: One drop of cyclosporine ophthalmic emulsion, 0.05%, is instilled twice a day in each eye approximately 12 hours apart. The emulsion can be used along with artificial tears, allowing a 15-minute interval between administrations of both products.

P&T Committee Considerations: In patients with chronic dry eyes, the production of normal tears is decreased because of chronic eye inflammation. This condition can cause significant discomfort. Other currently available therapies include artificial tears and ointments, which provide only temporary relief of symptoms.

Cyclosporine ophthalmic emulsion, 0.05%, appears to be a superior treatment. Dry eyes are most common in women over 45 years of age, in women experiencing menopause, and in patients with immune system diseases such as arthritis. The eye’s tear film is diminished because of the inflammation. Damage to the delicate tissues in the eye can lead to impaired vision. The lack of tears can be dangerous; tears defend the eye against bacteria and flush away foreign particles.

The topical ophthalmic emulsion increases tear production to a normal volume. It is the first and only therapy for patients with keratoconjunctivitis sicca, characterized by suppressed tear production, presumably from eye inflammation.

Cyclosporine ophthalmic emulsion, 0.05%, should be placed on the formulary as primary treatment of chronic dry eye disease. Artificial tears and ointments provide only symptomatic relief and do not address inflammation; in patients who were taking a topical anti-inflammatory agent or who were using punctal plugs, no increased tear production was observed.
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The average wholesale price for the single-use vials of the emulsion has not yet been determined.

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