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UNION CITY, Calif., Sept. 30 /PRNewswire/ -- MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today provided a clinical development update for Perceiva, the company's proprietary ocular sirolimus product. The company has completed patient enrollment in four ongoing Phase 2 clinical trials of Perceiva and plans to announce data from these studies in the first half of 2010. All four studies are being conducted at investigational sites in the United States. These studies, which are evaluating Perceiva as a treatment for diabetic macular edema (DME), neovascular (wet) age-related macular degeneration (wet AMD) and dry eye syndrome, are part of MacuSight's broad Phase 2 Perceiva clinical program which spans five major ocular disease indications.
"The completion of enrollment in these important clinical trials, which was achieved rapidly and, in some cases, ahead of our study timelines, represents a key milestone in our Phase 2 clinical program. Based on promising data from our two Phase 1 studies, as well as Perceiva's broad biological activity relevant to multiple ocular diseases, we elected to undertake this large Phase 2 program targeting five major ophthalmic disease markets," stated David A. Weber, Ph.D., president and chief executive officer of MacuSight. "We are excited by the progress that is being made with our ongoing clinical work and look forward to presenting the results early next year."
Perceiva Phase 2 Clinical Program Overview
MacuSight's DME study, known as the DIAMOND trial, has completed enrollment of 131 patients at 39 investigational sites. This randomized, dose-ranging, placebo-controlled study consists of four treatment arms (three different doses and placebo) administered by a minimally invasive subconjunctival injection. Patients enrolled in this trial are administered Perceiva at baseline and again at three months. Th
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