Inspire completes patient enrollment for dry eye, blepharitis trials

DURHAM, N.C. — Inspire Pharmaceuticals has completed patient enrollment in two late-stage ophthalmic clinical trials and has announced plans to complete enrollment in a third during the first quarter of 2010, according to a press release from the company.

The first phase 3 study, known as Trial 03-113, will compare Prolacria (diquafosol tetrasodium ophthalmic solution 2%) with placebo when administered four times daily to 450 patients with dry eye over 6 weeks. The trial, which is based on a special protocol assessment agreement with the U.S. Food and Drug Administration, is expected to produce top-line results during the first quarter of 2010, the release said.

Inspire's phase 2 clinical program regarding AzaSite (1% azithromycin ophthalmic solution) for treating blepharitis includes two arms — Trial 044-101 and Trial 044-102 — that are expected to enroll approximately 600 patients.

Enrollment for Trial 044-102, which will evaluate the safety and tolerability of the drug when administered over a 4-week period with 4 weeks of follow-up, has been completed. Trial 044-101, which will evaluate the drug when administered over a 2-week period with 2 weeks of follow-up, has enrolled 250 out of a targeted 300 patients. Inspire expects to finalize enrollment for this study in the first quarter of 2010, the release said.