Posted by Michael Wonder on 04 Apr 2020
IVERIC bio announces fast track designation from U.S. FDA for Zimura for the treatment of geographic atrophy secondary to dry age-related macular degeneration
3 April 2020 - IVERIC bio announced today that the U.S. FDA has granted fast track designation to Zimura (avacincaptad pegol), a novel complement C5 inhibitor, in development for the treatment of geographic atrophy secondary to dry age-related macular degeneration.
On 28 October 2019, the Company announced that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in an international, multicenter, randomized, double masked, sham controlled clinical trial in geographic atrophy secondary to dry age-related macular degeneration, referred to as the OPH2003 trial. Zimura was generally well tolerated after 12 months of administration.
