It’s good news for Allergan and Molecular Partners’ wet AMD drug. The duo announced Thursday that abicipar has met its endpoints in two Phase III trials, proving non-inferiority to the market-leading Lucentis.
In both 8- and 12-week regimens, abicipar met its primary endpoints, but also showed the incidence of intraocular inflammation was higher in patients on abicipar than those on Lucentis.
“We believe the SEQUOIA and CEDAR studies demonstrated what we set out to achieve, strong efficacy and duration of effect which shows the potential of abicipar as a treatment for AMD patients,” said David Nicholson, chief research and development officer at Allergan. “We have generated important findings in these trials to address a serious unmet need. We will continue to review these data including inflammation findings and are working on further optimizing the abicipar formulation.”
The filing for abicipar is planned for the first half of 2019, the company said. Allergan will be requesting a meeting with the FDA to discuss its BLA submission. The full data details of the primary and secondary endpoints will be presented at an upcoming scientific conference.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,500+ biopharma pros who read Endpoints News by email every day.Free Subscription