MacuSight(R) Provides Clinical Development Update for Pe...(nd a lead investigator of both wet AMD s...)

Date:9/30/2009

nd a lead investigator of both wet AMD studies. "While evaluating the biological activity of the product on its own is important, there is a rapidly advancing belief in the ophthalmology community that the future of wet AMD treatment lies in combination therapy. Furthermore, there is a critical need for safe and effective wet AMD treatment alternatives that have less frequent administration requirements. This product may possess the potential to address these needs."

MacuSight's fourth Phase 2 trial, in which the company is using Perceiva to evaluate the potential role for sirolimus in the treatment of dry eye syndrome, has successfully enrolled 143 patients at four investigational sites. For this trial, MacuSight worked with Ora, Inc., a leading global clinical research organization located in Andover, MA. As part of this randomized, dose-ranging, placebo-controlled study, patients receive a single subconjunctival injection of Perceiva at baseline. Investigators will evaluate signs and symptoms of dry eye over a period of 28 days following a single injection.

"In addition to these four separate studies that we are overseeing at MacuSight, our Perceiva Phase 2 program includes three trials sponsored by the National Eye Institute of the National Institutes of Health, as well as individual investigators," added Joel Naor, M.D., chief medical officer of MacuSight. "The NEI is conducting studies of Perceiva in DME, dry AMD and anterior uveitis. A separate investigator-sponsored trial in posterior uveitis is also currently enrolling patients. As a result of this extensive clinical development program, more than 500 patients across five major posterior and anterior segment ocular indications will have been dosed with Perceiva by the time the Phase 2 program is complete. This scope is virtually unprecedented for a Phase 2 program in the area of ocular drug development."

Perceiva Phase 1 Clinical Results

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SOURCE MacuSight Copyright©2009 PR Newswire. All rights reserved

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