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.

Read the whole article at Yahoo News: Inspire Initiates Diquafosol Phase III Dry Eye Trial