There was a decrease in the incidence of intraocular inflammation in the 28-week MAPLE study of abicipar pegol, Allergan and Molecular Partners announced in a press release.
The open-label study evaluated the safety of abicipar that was produced with a modified manufacturing process and used in 123 patients with neovascular age-related macular degeneration.
The incidence of intraocular inflammation was 8.9%, which was lower than the incidence observed in both the CEDAR and SEQUOIA phase 3 trials.
Allergan plans to file a biologics license application with the FDA for abicipar in the first half of the year, the release said.
“The results of this open-label study enabled us to assess improvements to the manufacturing process for abicipar. The safety profile demonstrated in MAPLE gives us confidence to proceed and scale up manufacturing,” David Nicholson, chief research and development officer at Allergan, said in the release. “We plan to submit the abicipar BLA and continue to pursue manufacturing process improvements as we develop larger-scale studies in additional disease states, such as diabetic macular edema.”
In the previous trials, abicipar demonstrated noninferiority to ranibizumab at both 8- and 12-week fixed-interval treatment regimens.
“Abicipar is our first DARPin candidate on track for BLA submission with the aim to become the first fixed 12-week anti-VEGF drug in all patients with [neovascular] AMD,” Michael T. Stumpp, chief operating officer of Molecular Partners, said in the release. “The safety data from the MAPLE trial are an important step in the further improvement of the manufacturing process of abicipar.”