May 21 2004
Researchers in the department of ophthalmology at the
University of Arizona College of Medicine in Tucson played an important role in the development of Restasis, the first alternative to artificial tears for the treatment of dry eye syndrome.
Dry eye syndrome (keratoconjunctivitis sicca) is a common and very painful condition affecting more than 1 million people in the U.S., especially older adults, post-menopausal women and those with Sjogren's Syndrome, rheumatoid arthritis, lupus, Parkinson's and other chronic diseases.
Characterized by insufficient tear production, the syndrome eventually may lead to vision loss. Symptoms - which include a dry, gritty feeling in the eyes, or burning, made worse by low humidity or windy days - are relieved only temporarily by artificial tears.
"Clinical trials conducted by our researchers and several other centers around the country helped provide the data for the Food and Drug Administration approval of the drug last year," says Dr. Robert Snyder, head of the UA department of ophthalmology. "This is an example of how basic science research can be translated into new therapies to fight eye disease and prevent vision loss."
The UA participated in a national clinical trial that compared the safety and
efficacy of Restasis with a lubricant eye drop that acts as an artificial tear in patients with mild to moderate dry eye syndrome. Allergan, Inc., manufacturer of both products, sponsored the study. (Study investigators Drs. Snyder and Robert Noecker also serve on the pharmaceutical company's Dry Eye Advisory Board.)
Many of the participants in the UA clinical studies of Restasis showed increased tear production and less need for artificial tears. Unlike artificial tears, which temporarily replenish eye moisture, Restasis helps treat the inflammation that causes dry eye syndrome.
Restasis contains 0.05 percent cyclosporin, a medication that, taken by mouth, prevents rejection of kidney, liver, heart and bone marrow transplants, and sometimes is used to treat rheumatoid arthritis and other conditions. In eye drop form, cyclosporin helps reduce inflammation of both the tear-producing lacrimal gland and the surface of the eye.
"In the last decade, researchers found that the immune systems of patients with dry eye syndrome were rejecting their own tear-producing cells," says Dr. Snyder. "This inflammatory reaction could be triggered by a number of factors, including decreased hormone production, as in menopause; eye surgery that reduces the sensation on the corneal surface; or exposure as seen in Parkinson's disease patients who have poor blinking."
"About 15 years ago, a veterinary ophthalmologist at the University of Georgia discovered that cyclosporin could treat dry eye in dogs; she ultimately used it to treat the dry eyes of the school's mascot, Uga, a bulldog," notes Dr. Snyder. "Subsequent studies in people confirmed that it could reduce inflammation that leads to dry eye and even increase tear production."
"Cyclosporin, however, only became a dry eye wonder drug when scientists at Allergan learned how to formulate it so it could be applied as an eye drop. This new use of cyclosporin provides the first alternative therapy for this frustrating and painful condition," explains Dr. Snyder.
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