RESTASIS®, IKERVIS (Cyclosporine)

RESTASIS (Cyclosporine) Ophthalmic Emulsion helps increase the eyes’ natural ability to produce tears which may be reduced by inflammation. Restasis did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.

Restasis is covered by most insurance plans in the U.S., and must be prescribed by a doctor.

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The active ingredient, cyclosporine, is an immunosuppresant drug. It is used to prevent organ rejection after transplants and to suppress autoimmune conditions.

Results of Restasis (Cyclosporine) Clinical Trials

The findings in four pre-marketing clinical studies showed that only 10-15% of subjects had improved Schirmer test scores after using Restasis. According to the study:

“Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca (Dry Eye). RESTASIS demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.”

It is not understood exactly how Restasis works. According to the report:

“In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.”

The most common adverse reaction following the use of Restasis was ocular burning (17%).

In January 2015 The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of cyclosporine eye drops, Ikervis, for the treatment of severe keratitis in adults with Dry Eye.

Common adverse reactions of Ikervis are eye pain (19%), eye irritation (17.8%), lacrimation (6.2%), ocular hyperemia (5.5%), and eyelid erythema (1.7%).

Single-dose and multi-dose vials are available in the U.S. for the same price.