MacuSight Receives Fast Track Designation From FDA

MacuSight 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. Reportedly, the company has recently completed enrolment 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 report data from these studies in the first half of 2010.

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.

Joel Naor, chief medical officer of MacuSight, said: “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. Based on our clinical research to date with Perceiva in DME patients, we believe that this drug candidate may offer those patients a safe and effective treatment. We remain focused on advancing the clinical development of Perceiva for DME and other ocular diseases in as expeditious a manner as possible and look forward to announcing data from our Phase 2 clinical program in the first half of 2010.”

MacuSight recently revealed that it had completed enrolment of 131 patients in its ongoing Phase 2 DME study of Perceiva, known as the Diamond trial. 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. The primary endpoints for the trial are visual and anatomical improvements measured at six months, three months following the second administration of Perceiva. The company plans to reveal data from this study, along with the its three additional ongoing Phase 2 trials, in the first half of 2010.

The company claimed that two Phase 1 clinical trials of Perceiva in patients with DME and wet AMD have been completed. Findings from both studies, which included a total of 80 patients, demonstrated the product to be safe and well-tolerated in all doses tested with two different routes of administration (minimally invasive subconjunctival injection, as well as traditional intravitreal injection). In addition, investigators from both studies noted improvements in visual acuity consistent with observed beneficial anatomical changes following a single administration of Perceiva. These results for Perceiva delivered with subconjunctival injection provide the first evidence for the potential of treating retinal disease without direct injection into the back of the eye.