Allergan and Molecular Partners Announce Topline Safety Results from MAPLE study of Abicipar pegol
- The MAPLE study used a modified manufacturing process and demonstrated decreased intraocular inflammation
- Previously reported positive Phase 3 results demonstrated the potential for abicipar to be the first anti-VEGF therapy to maintain initial vision gains in all patients on a true fixed 12-week dosing interval
- Abicipar BLA submission to the FDA planned for first half of 2019
DUBLIN, IRELAND – April 2, 2019 – Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® therapies, today announced topline safety results from MAPLE, a 28 week open-label study which enrolled 123 age-related Neovascular Macular Degeneration (nAMD) patients and evaluated the safety of abicipar produced via a modified manufacturing process. In this single arm study, treatment naïve 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 (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 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 this study.