The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for avacincaptad pegol for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD).
Avacincaptad pegol is an investigational complement C5 protein inhibitor designed to decrease the activation of inflammasomes and the formation of membrane attack complex, thereby preventing or slowing the degeneration of retinal pigment epithelial cells.
The NDA is supported by data from the randomized, double-masked, sham-controlled, multicenter phase 3 GATHER1 (ClinicalTrials.gov Identifier: NCT02686658) and GATHER2 (ClinicalTrials.gov Identifier: NCT04435366) trials, which evaluated the efficacy and safety of avacincaptad pegol in patients 50 years of age and older with geographic atrophy secondary to AMD. Patients were randomly assigned to receive either avacincaptad pegol via intravitreal injection once monthly or sham.
The primary endpoint for both trials was the mean rate of change in geographic atrophy, as measured by fundus autofluorescence at baseline, month 6, and month 12. Results showed that treatment with avacincaptad pegol led to a significant reduction in the mean rate of growth (slope) in geographic atrophy area from baseline to month 12 compared with sham.
The most frequently reported treatment-emergent adverse event was related to injection procedure. The most common adverse reactions reported were conjunctival hemorrhage (13%), increased intraocular pressure (9%), and choroidal neovascularization (7%). No cases of serious intraocular inflammation, vasculitis, or endophthalmitis were observed.
“The FDA’s acceptance of our NDA and Priority Review for avacincaptad pegol bring us another significant step closer to delivering a much-needed treatment to AMD patients living with [geographic atrophy],” said Glenn P. Sblendorio, CEO of Iveric Bio. “We look forward to continuing our collaboration with the FDA throughout the review process.”
A Prescription Drug User Fee Act (PDUFA) target date of August 19, 2023 has been assigned to this application. The FDA previously granted Fast Track and Breakthrough Therapy designations to avacincaptad pegol for this indication.
Iveric Bio announces FDA accepts New Drug Application and grants Priority Review for avacincaptad pegol for the treatment of geographic atrophy. News release. Iveric Bio. Accessed February 16, 2023. https://www.businesswire.com/news/home/20230216005773/en/Iveric-Bio-Announces-FDA-Accepts-New-Drug-Application-and-Grants-Priority-Review-for-Avacincaptad-Pegol-for-the-Treatment-of-Geographic-Atrophy.