Tuesday, November 3, 2009

Drug news: Macusight receives fast track status for Perceiva

MacuSight(R) Receives Fast Track Designation From FDA for Perceiva(TM) in Treatment of Diabetic Macular Edema

As reported previously, Macusight has Perceiva (ocular sirolimus) in four different Phase II trials, one of which is for dry eye. Perhaps with their new fast track designation in one indication, the other indications will enjoy some benefit along the way....

..."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," stated Joel Naor, M.D., chief medical officer of MacuSight. "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."

No comments: