Dry eye is a disease of the tears and ocular surface that leads to instability of the tear film, symptoms of discomfort and visual disturbance. The disease is usually characterized by either a decrease in tear production, which results in tear deficiency, or an imbalance in the composition of the tear film components, which leads to an unstable tear film and increased tear evaporation. If left untreated, dry eye disease can result in damage to the ocular surface and visual impairment.
Dry eye disease affects an estimated 21 million people 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 PROLACRIA and RESTASIS have different mechanisms of action, we consider them complementary products with significant commercial opportunity.
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.
PROLACRIA is a potent and selective P2Y2 receptor agonist. Activation of these receptors on the ocular surface stimulates release of the three natural tear components involved in tear secretion - mucin, lipids and fluid.
PROLACRIA was discovered and is being developed by Inspire and has intellectual property coverage, including a composition of matter patent, through at least 2017. Inspire filed a New Drug Application (NDA) for PROLACRIA for the treatment of dry eye with the FDA in 2003 and received an approvable letter in December 2003. Inspire submitted an amendment to the NDA in June 2005 and received an additional approvable letter in December 2005.
In June 2001, Inspire and Allergan, Inc. entered into a joint license, development and marketing agreement to develop and commercialize PROLACRIA for dry eye disease worldwide, except Japan and nine other Asian countries. Inspire is responsible for conducting, in collaboration with Allergan, the Phase 3 clinical trials needed for potential FDA approval of PROLACRIA. Allergan is responsible for all other development activities under the agreement, including all development and regulatory activities needed for potential approval outside the United States and in its territories, and for ex-U.S. regulatory submissions, filings, and approvals relating to products. In addition, Allergan is responsible for all commercial costs except for the cost of our sales force in the United States.
In December 1998, Inspire and Santen Pharmaceutical Co., Ltd. entered into a development, license and supply agreement for the development of diquafosol tetrasodium for the treatment of ocular surface diseases, such as dry eye, in Asia. Santen is responsible for developing and marketing diquafosol tetrasodium products in Japan and nine other Asian countries. Santen filed an application for manufacturing and marketing approval for its formulation of diquafosol tetrasodium, which Santen refers to as DE-089, with the Japanese Ministry of Health, Labor, and Welfare (the Japanese equivalent of the FDA) on May 30, 2008.
*Market Scope, Report on the Global Dry Eye Market. St. Louis, MO: Market Scope, July 2004.(diquafosol tetrasodium ophthalmic solution) 2% for dry eye - Phase 3; Approvable
Denufosol tetrasodium inhalation solution for cystic fibrosis - Phase 3
(azithromycin ophthalmic solution) 1% for blepharitis - Phase 2
INS115644 and INS117548 for glaucoma - Phase 1
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Page Updated on: 3/8/2010
