FDA grants Breakthrough Therapy designation for avacincaptad pegol for geographic atrophy
The U.S. Food and Drug Administration has granted Breakthrough Therapy designation for avacincaptad pegol (Zimura; Iveric Bio), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
This is the first investigational therapy to receive Breakthrough Therapy designation status for GA secondary to AMD.
The designation was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials.
“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%,” said Pravin U. Dugel, MD, President of Iveric Bio in a press release. “We believe avacincaptad pegol has the potential to safely and effectively preserve central vision by saving photoreceptor cells for patients living with this life-changing disease that leads to irreversible blindness.”
Iveric Bio has submitted the first part of its New Drug Application (NDA) for rolling review and is on track to complete the final part of the NDA submission by the end of 2023.
Read the full press release here.