October 21, 2009 - MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME). MacuSight is currently advancing Perceiva in a broad Phase 2 clinical program across multiple large ocular indications. The company recently announced that it had completed enrollment in four separate Phase 2 studies which are evaluating Perceiva as a treatment for DME, neovascular (wet) age-related macular degeneration (wet AMD) and dry eye syndrome. The company plans to announce data from these studies in the first half of 2010.FDA's process for providing Fast Track designation is intended to facilitate the development and expedite the review of drugs that treat serious or life-threatening diseases and address an unmet medical need. With this designation, MacuSight will be provided the opportunity to submit portions of a New Drug Application (NDA) for Perceiva as they are completed instead of filing all completed portions of the NDA at one time. As a result, FDA may begin its review of the application as portions are received, potentially accelerating the review and approval process.
"By granting Fast Track status to Perceiva for the treatment of DME, the leading cause of vision loss among working-age adults, FDA is providing an accelerated pathway for delivering this potentially important therapeutic to patients in need of effective treatment options... MacuSight's Press Release -
