Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Immunology | Ophthalmology
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Restasis (cyclosporine ophthalmic emulsion)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: December 2002
Treatment Area: Low tear production due to ocular inflammation associated with keratoconjunctivitis sicca.
Restasis (cyclosporine emulsion) is a topical formulation
indicated for the treatment of reduced tear productoin due to
inflammation from dry eye disease. While the routine, daily use of
artificial tears provides symptomatic relief, Restasis helps fight
the cause of the condition.
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
Adverse events associated with the use of Restasis may include
(but are not limited to) the following:
- Ocular Burning
- Conjunctival Hyperemia
- Eye Pain
- Foreign Body Sensation
- Visual Disturbance
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
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
Zhan H, Smith L, Calder V, Buckley R, Lightman
S. Clinical and immunological features of atopic
keratoconjunctivitis. Int Ophthalmol Clin.2003
Avunduk AM, Avunduk MC, Tekelioglu Y. Analysis
of tears in patients with atopic keratoconjunctivitis, using flow
cytometry. Ophthalmic Res. 1998;30(1):44-8.
Stern ME, Beuerman RW, Fox RI, Gao J, Mircheff AK,
Pflugfelder SC. The pathology of dry eye: the interaction
between the ocular surface and lacrimal glands. Cornea.