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Dry eye, an ocular surface disease, is the general term for a condition in which abnormalities in the eye's tear film lead to burning, painful, red, irritated, gritty and dry eyes. These abnormalities are typically characterized by a decrease in tear production, an increase in tear evaporation or the improper mixture of the eye's tear film components. If left untreated, dry eye disease can result in permanent corneal damage and visual impairment. Restasis® (cyclosporin ophthalmic emulsion, 0.05%) is currently the only FDA-approved, pharmacologically active treatment for dry eye in the United States. Restasis has been shown to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation. Because diquafosol and Restasis have different mechanisms of action, we consider them complementary products and believe the commercial opportunity of these products to be significant Other than Restasis, the current treatments for dry eye disorders in the major markets consist of artificial tear solutions and lubricant drops. In some cases, small plugs are inserted by physicians in the tear ducts to slow tear drainage. Artificial tears, which are available as over-the-counter and, in some countries as prescription products, provide temporary relief of symptoms, but can also wash out the natural proteins and other components that keep an eye healthy. We estimate, based on an extrapolation from United States data, that moderate to severe dry eye disease affects approximately thirty million people in the eight major international prescription pharmaceutical markets and ten million of these are in North America. Dry eye disease can be caused by eye stress, aging, environmental factors, autoimmune disorders and various medications. Because dry eye disease is more prevalent among the elderly and post-menopausal women, this market is expected to grow as populations age.
Page last updated: 8-Sep-2006
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