Final part of rolling submission of Zimura to FDA in geographic atrophy completed
IVERIC bio announced that it has submitted to the FDA the third and final part of its New Drug Application (NDA) for rolling review of Zimura (avacincaptad pegol or ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD)
Per the company’s agreement with the FDA for rolling NDA review, part 3 of the NDA included chemistry, manufacturing, and controls data.
The NDA submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials. ACP is the only investigational product for treatment of GA to achieve the pre-specified 12-month primary endpoint in two phase III pivotal trials with observed efficacy rates of up to 35%. In addition, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation for GA secondary to AMD.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.