Allergan PLC and Molecular Partners AG said the applications for their eye drug Abicipar were accepted by the U.S. Food and Drug Administration and the European Medicines Agency.
Both regulators will review the drug as a treatment for neovascular age-related macular degeneration, or nAMD, a disorder associated with the growth of abnormal blood vessels underneath the retina, which can lead to severe vision loss.
Abicipar targets the vascular endothelial growth factor, which helps abnormal blood vessels to grow in the eye.
The applications are based on results from two head-to-head phase 3 studies, named Sequoia and Cedar, where Abicipar restored the stable vision in the patients. The drug worked as well as Novartis AG's Lucentis, which has been approved by the FDA to treat nAMD since October 2016.
Dublin-based Allergan and Switzerland's Molecular Partners expect the FDA and the European Commission to decide on the drug's application by mid-2020 and in the second half of 2020, respectively.
Allergan acquired global rights for the Abicipar from Molecular Partners in May 2011 for an up-front payment of $45 million. The drug was developed using Molecular Partners' proprietary DARPin technology.
Molecular Partners' share price was up 8.7% to CHF15.20 on the SWX Swiss Exchange at market close Sept. 9.
