MacuSight gets FDA fast-track designation for DME therapy

November 4, 2009

MacuSight has received fast-track designation from the FDA for its proprietary ocular sirolimus (Perceiva) product for the treatment of diabetic macular edema.

Union City, CA

-MacuSight has received fast-track designation from the FDA for its proprietary ocular sirolimus (Perceiva) product for the treatment of diabetic macular edema (DME).

The company recently completed enrollment in four separate phase II studies evaluating the drug as a treatment for DME, neovascular (wet) age-related macular degeneration (AMD), and dry eye syndrome. The company plans to announce data from these studies in the first half of next year.

Additionally, two phase I clinical trials of the drug in patients with DME and wet AMD have been completed. Findings from both studies, which included a total of 80 patients and tested two routes of administration-subconjunctival injection and intravitreal injection-demonstrated the drug to be safe and well-tolerated in all doses tested, according to the company. Investigators from both studies also noted improvements in visual acuity consistent with observed beneficial anatomic changes following a single administration of the drug via either route.

With the fast-track designation, MacuSight will be able to submit portions of a new drug application (NDA) for its sirolimus formulation as they are completed instead of filing all completed portions of the NDA at one time. As a result, the agency may begin its review of the application as portions are received, potentially accelerating the review and approval process.