FDA Grants Breakthrough Therapy Status to Iveric Bio’s Zimura for AMD
The FDA has granted Breakthrough Therapy status for Iveric Bio’s Zimura (avacincaptad pegol) for geographic atrophy secondary to age-related macular degeneration (AMD) which leads to progressive and irreversible vision loss.
Zimura is an investigational drug designed to target the C5 protein, which is suspected to play a role in the scarring and vision loss associated with geographic atrophy secondary to AMD. There are currently no FDA-approved or European Medicines Authority-authorized treatments for the drug’s intended population.
By targeting C5, avacincaptad pegol “has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression” of the disease, the company said.
Iveric Bio plans on completing its new drug application for the investigational drug by the end of this year.