Restasis (cyclosporine ophthalmic emulsion)
Company: Allergan
Approval Status: December 2002
Treatment for: Low tear production due to ocular inflammation associated with keratoconjunctivitis sicca.
Areas: Immunology/Infectious Diseases; Ophthalmology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
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.
Clinical 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.
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
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.
Literature References
Zhan H, Smith L, Calder V, Buckley R, Lightman S. Clinical and immunological features of atopic keratoconjunctivitis. Int Ophthalmol Clin.2003 Winter;43(1):59-71.
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. 1998;17(6):584-589.
Additional Information
For additional information on Restasis or eye disease, please contact The Allergan web site
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
