April 15, 2001
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Inspire will present dry eye results at ARVO

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DURHAM, N.C. — Inspire Pharmaceuticals will present “positive” phase 2 results of INS365 Ophthalmic for the treatment of dry eye disease at the Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale May 3.

The phase 2 trial, a double-masked, parallel-group, dose-ranging, placebo-controlled study, was conducted at 12 ophthalmology centers in the U.S. The study compared several concentrations of INS365 Ophthalmic topical eye drop solution, ranging from 0.5% to 5%, and placebo in 158 moderate-to-severe patients.

The study showed that INS365 Ophthalmic was very well tolerated and demonstrated a statistically significant improvement over placebo on an important objective efficacy endpoint, corneal staining, according to the company.

The multi-center phase 3 program for INS365 Ophthalmic is now under way in the US. Inspire’s Asian partner, Santen Pharmaceutical Co., is currently conducting a phase 1 study in Japan.

INS365 Ophthalmic is a small-molecule drug that stimulates the P2Y2 receptor, a key mediator of mucosal-surface hydration and lubrication.