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Allergan, Molecular Partners Report Topline Safety Results From MAPLE Study

Allergan plc, (AGN) and Molecular Partners announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration patients and evaluated the safety of abicipar produced via a modified manufacturing process. The company said, as a result of the improvements in the manufacturing process, the incidence of intraocular inflammation or IOI, was 8.9 percent in the MAPLE study, which was lower than the rate observed in prior Phase 3 studies. Most IOI events were assessed as mild to moderate in severity, the company said. The incidence of severe IOI was 1.6 percent with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in the study.

"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," said David Nicholson, Chief Research and Development Officer, Allergan.

Allergan expects to file the abicipar Biologics License Application with the U.S. FDA in the first half of 2019.

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