Phase III dry eye study results revealed

March 15, 2005

Durham, NC—Inspire Pharmaceuticals has announced the results of a phase III clinical study of diquafosol tetrasodium for treatment of dry eye. The 6-week study was a randomized, double-masked comparison of 2% diquafosol ophthalmic solution versus placebo involving 640 patients at 34 clinical sites across the United States.

Durham, NC-Inspire Pharmaceuticals has announced the results of a phase III clinical study of diquafosol tetrasodium for treatment of dry eye. The 6-week study was a randomized, double-masked comparison of 2% diquafosol ophthalmic solution versus placebo involving 640 patients at 34 clinical sites across the United States.

In this study, diquafosol failed to demonstrate statistically significant improvement as compared with placebo for the primary endpoint of the incidence of corneal clearing. Improvement compared with placebo was achieved for a number of secondary endpoints, including mean corneal staining, mean conjunctival staining, and conjunctival clearing.

The positive results in mean corneal staining and mean conjunctival staining are consistent with results seen in previous phase III studies of diquafosol. Additional secondary endpoints included symptom assessment using the Ocular Surface Disease Index and analysis of patients' worst symptom score. Diquafosol failed to show improvement in symptoms compared with placebo in either assessment.