New Treatment May Be Watershed for "Dry Eye"

Newswise — Millions of Americans suffer from "dry eye" associated with Sjögren's syndrome and other autoimmune diseases, and for many, over-the-counter eye drops don't work sufficiently. These patients may find relief using a common immunosuppressive drug call cyclosporine, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Orlando, Florida.

A total of 877 patients with moderate to severe dry eye were enrolled in two six-month clinical trials comparing the safety and efficacy of topical cyclosporine delivered at two different strengths with that of an oil-based emulsion compound mixed with the medicine but which did not contain cyclosporine. The efficacy of topical cyclosporine in patients with Sjögren's syndrome or other autoimmune disease was compared to patients without autoimmune disease by measuring the change in patient's Schirmer's test score data (a test used to determine whether the eye produces enough tears to keep it moist). Complete Schirmer data were available for 741 patients; 265 of these patients had a diagnosis of autoimmune disease and of these, 94% had Sjögren's syndrome. Similar to the results from the entire study population, cyclosporine 0.05%, the lowest strength tested, was shown to significantly improve tear production in patients with dry eye associated with Sjögren's syndrome and other autoimmune diseases.

Dry eye, formally known as keratoconjunctivitis sicca, is a persistent dryness of the cornea and conjunctiva due to decreased function of the tear glands or increased evaporation of tears. It is present in virtually everyone with Sjögren's syndrome, estimated to affect from 1 to 4 million Americans, and in about 30% of patients with other autoimmune diseases. Symptoms of dry eye range from mild irritation and foreign body sensation to severe discomfort with sensitivity to light. Cyclosporine is an immunosuppressive drug previously available only in oral doses or by injection. It is now available in a topical formulation, and importantly, at the marketed 0.05% concentration is not detected in the blood.

"Topical cyclosporine has dramatically changed the way we treat dry eye disease. Research has shown us that inflammation is an important cause of dry eye, both in patients with autoimmune conditions like Sjögren's syndrome and in people without underlying autoimmune disease," said Scott Whitcup, MD, Vice President and Head, Ophthalmology Therapeutic Area, Allergan, in Irvine, California, and senior author of the study. "Unlike artificial tears, topical cyclosporine treats the underlying cause of dry eye and leads to increased tear production in the majority of patients in our clinical studies."

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see http://www.rheumatology.org/annual.