Astellas Pharma Inc. (ALPMY) has announced that it has submitted a New Drug Application (NDA) in Japan, seeking conditional approval for Avacincaptad Pegol intravitreal solution (ACP) intended for the treatment of geographic atrophy, a form of dry age-related macular degeneration (AMD).
Avacincaptad Pegol is a synthetic aptamer designed to inhibit the complement protein C5.
Astellas highlighted that the Japanese Ministry of Health, Labour and Welfare will be assessing ACP as a potentially pioneering treatment option for patients suffering from geographic atrophy. The assessment will also consider its effectiveness for age-related macular degeneration in Japan.
Geographic atrophy is a gradually advancing condition of AMD that can lead to irreversible vision loss, and currently, no treatments have been approved outside the United States and Australia.
The NDA submission is underpinned by results from international clinical trials, including the GATHER1 and GATHER2 randomized, sham-controlled studies.
