TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) Wednesday announced the submission of a New Drug Application or NDA in Japan for Conditional Approval of Avacincaptad Pegol intravitreal solution or ACP for the treatment of geographic atrophy or dry age-related macular degeneration or AMD.
Avacincaptad is a synthetic aptamer that inhibits the complement C5 protein.
Astellas said the Ministry of Health, Labour and Welfare will evaluate ACP as a potential first treatment for patients with geographic atrophy. The company will also evaluate secondary to age-related macular degeneration in Japan.
Geographic atrophy is a progressive form of AMD that can cause irreversible vision loss, with no treatments currently approved outside the US or Australia.
The NDA submission is based on results of overseas clinical trials, including the GATHER1 and GATHER2 randomized, sham-controlled clinical trials.
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