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Phase 3 Trial of Diquafosol Initiated, Treatment for Dry Eye

DURHAM, N.C., June 2 /PRNewswire-FirstCall/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH - News) today announced the initiation of a Phase III trial of diquafosol tetrasodium for the treatment of dry eye. Inspire received an approvable letter for diquafosol from the Food and Drug Administration (FDA) in December 2003 and met with the agency in January 2004 to clarify requirements for approval. The FDA indicated that an additional clinical study would be required to provide additional evidence of the efficacy of this potential treatment.

The Phase III trial is a double-masked, randomized, placebo-controlled safety and efficacy study of diquafosol tetrasodium 2% ophthalmic solution in patients with dry eye. The study will be conducted in approximately 500 patients at 36 U.S. sites that are experienced in the conduct of dry eye trials. Diquafosol or placebo will be administered four times daily over a six-week treatment period.

Christy L. Shaffer, Ph.D., Inspire's CEO, commented, "We recently incorporated the final comments from the FDA into the protocol for this study and have begun patient enrollment. We expect to report results and, if positive, submit an amendment to the NDA by mid-2005. Our clinical and regulatory teams are focused on completing this trial in the most timely and efficient manner possible."

About Dry Eye
Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It affects approximately 10 million North Americans and is one of the most frequent patient complaints reported to ophthalmologists and optometrists. The majority of dry eye patients rely on artificial tears to relieve symptoms.

Source: Inspire Pharmaceuticals, Inc.

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