Allergan 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. In this single arm study, treatment naive or prior anti-VEGF treated patients received three monthly 2mg abicipar injections followed by 2mg injections every 8 weeks for up to a total of five injections through week 28. As a result of the improvements in the manufacturing process, the incidence of intraocular inflammation was 8.9% 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 incidence of severe IOI was 1.6% with one reported case of iritis and one reported case of uveitis. There were no reported cases of endophthalmitis or retinal vasculitis in this study. Allergan expects to file the abicipar Biologics License Application with the U.S. FDA in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.
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