The FDA has accepted a biologics license application and the European Medicines Agency has validated a marketing authorization application for abicipar pegol, an investigational DARPin therapy for wet age-related macular degeneration, Allergan and Molecular Partners announced in a press release.
The two filings are based on data from the CEDAR and SEQUOIA phase 3 trials, which assessed the efficacy and safety of abicipar compared with Lucentis (ranibizumab, Genentech). In both trials, abicipar showed similar efficacy in six or eight injections compared with 13 ranibizumab injections.
“Acceptance
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