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Ista initiates clinical program for dry eye disease
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IRVINE, Calif. — Ista Pharmaceuticals initiated a new phase 3 program designed to evaluate its proprietary formulation of Remura dry eye solution, the company announced in a press release.
Ista will assess the safety and efficacy of Remura (bromfenac ophthalmic solution) through four randomized, double-masked, placebo-controlled phase 3 studies being conducted under a Special Protocol Assessment agreed upon with the U.S. Food and Drug Administration.
Approximately 1,000 patients with mild to moderate dry eye disease will be randomized to receive either bromfenac or placebo in both eyes twice daily and will be evaluated over the course of 42 days, according to the release.
The multicenter trials will be conducted at more than 30 sites across the U.S., and Ista plans to report the results in the middle of 2011.
In addition, the company will initiate both 6-month and 12-month safety studies later this year in order to meet FDA guidance on drugs for chronic dosing, according to the release.