Inspire Pharmaceuticals has announced the completion of subject enrollment and dosing in Phase I trials of INS365 ophthalmic solution, its first ophthalmic product.

Conducted in the United Kingdom, the study was a double-masked, randomized, placebo-controlled, dose-escalation investigation, featuring subject-paired comparison. The objective was to determine safety and tolerability in 50 volunteers who had dry eyes.
Results indicate that the four dose levels (0.5%, 1%, 2% and 5%), administered topically t.i.d. over 1 day in normal volunteers, were both safe and generally well tolerated.

The company plans to file an investigational new drug application (INDA) in the United States late this year. It will also initiate clinical testing in dry eye patients. Inspire has already secured an Asian partner, Santen Pharmaceutical Co., Ltd., to develop and commercialize the product in Japan and nine other Asian countries.
In studies conducted on rabbits, INS365 ophthalmic solution increased tear secretion during 14 days of treatment. The effects were dose-related and were significantly greater than tear secretion in the control group.