October 21, 2009
FDA fast track designation granted for Perceiva for diabetic macular edemaMacuSight announced that the FDA has granted fast track designation to Perceiva (sirolimus ophthalmic injection) for the treatment of diabetic macular edema (DME). The DIAMOND trial, a Phase 2, randomized, dose-ranging, placebo-controlled study evaluating Perceiva in the treatment of DME has recently completed enrollment. Patients enrolled in this trial have been randomized to receive three different doses of Perceiva or placebo by subconjunctival injection 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.
Perceiva is an ocular formulation of sirolimus, an mTOR inhibitor. Sirolimus possesses a broad spectrum of therapeutic actions potentially relevant to the treatment of ocular diseases, including the inhibition of inflammation, angiogenesis, vascular permeability, proliferation and fibrosis.
For more information call (510) 400-1440 or visit www.macusight.com.