General Information

Restasis (cyclosporine emulsion) 0.05% is a calcineurin inhibitor immunosuppressant.

Restasis is specifically indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. 

Restasis is supplied as an ophthalmic emulsion. Instill one drop of Restasis ophthalmic emulsion twice a day in each eye approximately 12 hours apart.

Mechanism of Action

Restasis (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporine, a fine white powder, is an immunosuppressive agent when administered systemically. Cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

Evidence indicates that inflammation of both the lacrimal gland and ocular surface is at the root of keratoconjunctivitis sicca, commonly referred to as dry eye disease. Restasis helps to reduce that inflammation.

Side Effects

Adverse events associated with the use of Restasis may include (but are not limited to) the following:

• Ocular Burning
• Conjunctival Hyperemia
• Discharge
• Epiphora
• Eye Pain
• Foreign Body Sensation
• Pruritus
• Stinging
• Visual Disturbance

Clinical Trial Results

Approval of Restasis is based on four multicenter, randomized, clinical studies performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca.

Restasis demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in subjects whose tear production was presumed to be suppressed due to ocular inflammation. Data showed that 15% of subjects treated with Restasis showed increased tear production compared to 5% of vehicle treated patients. No increase in tear production was observed in subjects being treated with anti-inflammatory drugs or using punctal plugs.