Inspire Announces Results of Phase III Dry Eye Study

Inspire Pharmaceuticals has announced results of a Phase III clinical study of diquafosol tetrasodium for treatment of dry eye.

The six-week study was a randomized, double-masked comparison of 2 percent diquafosol ophthalmic solution to placebo conducted in 640 patients at 34 clinical sites across the U.S.

In this study, diquafosol failed to demonstrate statistically significant improvement as compared to placebo for the primary endpoint of the incidence of corneal clearing. Improvement compared to 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 assessments using the Ocular Surface Disease Index and analysis of patients' worst symptom score. Diquafosol failed to show improvement in symptoms compared to placebo in either assessment.

As in previous studies, the most common ocular adverse event, burning/stinging on instillation, occurred more frequently on diquafosol than on placebo, but the incidence was less than 5 percent.