Cyclosporine Treatment for Dry Eye May Be Shortened in Some Patients

Linda Little

October 19, 2005

Oct. 19, 2005 (Chicago) — A small number of people being treated for dry eyes — a condition that affects 4.2 million Americans — may be able to discontinue the only prescription drug currently on the market. Researchers here at the International Society of Refractive Surgery at the American Academy of Ophthalmology annual meeting reported that cyclosporine ophthalmic emulsion (Restasis; Allergan), once thought to require indefinite treatment, may be required for only six months in a small subset of patients.

"This is the most common condition seen in ophthalmology practice," Steven E. Wilson, MD, director of corneal research at the Cole Eye Institute of the Cleveland Clinic Foundation in Ohio, stated regarding dry eye syndrome. "This is a condition that increases with age."

Indeed, 5.7% of women older than 50 years had dry eye syndrome in the Women's Health Study (which includes almost 40,000 women), a figure that increased to almost 8% for those aged 75 years or older. "About 80% of those dry eyes worsen. It's a complex problem," Dr. Wilson said.

Until cyclosporine ophthalmic emulsion came on the market three years ago, patients often used artificial tears for relief from dry eye symptoms. Such tears give only temporary relief, and do not contain the normal components of tears. The availability of cyclosporine did not necessarily provide a viable alternative, however, because it required indefinite use.

Now, according to Dr. Wilson and coauthor Henry D. Perry, MD, from Ophthalmic Consultants of Long Island, New York, that may no longer be the case.

They treated 379 patients (127 in Dr. Wilson's practice, 252 in Dr. Perry's practice) with topical 0.05% cyclosporine A with or without topical corticosteroids twice a day along with nonpreserved artificial tears. Patients provided their history and underwent slit lamp examination, rose Bengal, fluorescein staining of the ocular surface, tear break-up time, and Schirmer's test with and without anesthesia. After six months of treatment, if there were no signs of symptoms of dry eye, Dr. Wilson reported that he took patients off treatment and followed them. Almost 4% of the patients — and close to 2% in Dr. Perry's practice — were able to go without cyclosporine.

"Treatment with topical cyclosporine A appears to be associated with a cure of symptoms in a subgroup of chronic dry eye patients," said Dr. Wilson.

The patients, all of whom had been treated for at least six months, were free of the inflammatory processes in chronic dry eye disease for a minimum of one year.

"This suggests that topical cyclosporine may reverse or at least halt the progression of chronic dry eye in some patients," Dr. Wilson said during a press conference. However, further study will have to be done to determine which patients are most likely to be able to stop the drug once treatment has begun.

Dr. Wilson estimated that 80% of patients with dry eyes would likely still have to stay on the drug for the long term. Those treated early on have the best chance of halting the progression, he said. "Basically any patients with confirmed symptoms and signs of dry eye should be treated."

Other advances in dry eye syndrome reported at the conference include the potential to use cyclosporine in patients with dry eye from LASIK, and another drug is in development that appears to stimulate the release of natural tears.

ISRS at the AAO Annual Meeting: Press conference. Presented October 15, 2005.

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