FDA Grants Priority Review to AMD Therapy
Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.
The FDA has granted priority review to Iveric Bio’s new drug application (NDA) for avacincaptad pegol (ACP) to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Prescription Drug User Fee Act (PDUFA) goal date is Aug. 19, 2023. The company said the FDA is not currently planning to hold an Advisory Committee meeting.
Age-related macular degeneration is the major cause of moderate and severe loss of central vision in aging adults. Geographic atrophy, which is associated with AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. FDA approved treatment options for patients with geographic atrophy.
Avacincaptad pegol is complement C5 inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the scarring and vision loss associated with geographic atrophy secondary to age-related macular degeneration. By targeting C5, avacincaptad pegol has the potential to slow the progression of geographic atrophy.
The NDA submission is based on the 12-month primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials. Avacincaptad pegol achieved the pre-specified 12-month primary endpoint in two phase 3 pivotal trials with observed efficacy rates of up to 35%. The most frequently reported treatment emergent adverse events in the 2 mg recommended dose were related to injection procedure. The most common adverse reactions reported in patients who received avacincaptad pegol were conjunctival hemorrhage, increased intraocular pressure (9%), and choroidal neovascularization (creation of new blood vessels in the choroid layer of the eye (7%).
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