Neovascular macular degeneration - Topline safety results from study of abicipar for treatment

Allergan plc, and Molecular Partners , a clinical-stage biotechnology company developing a new class of drugs known as DARPin therapies, 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 III 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.

"It is encouraging to see the lower incidence and type of IOI observed in this open label 28-week study," said Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine. "In the Phase III trials previously reported, abicipar demonstrated potential that could transform the way physicians manage nAMD with anti-VEGF therapy. Abicipar could be the first fixed 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients."

Comment: Allergan expects to file the abicipar Biologics License Application (BLA) with the FDA in the first half of 2019. Additional data from the MAPLE study will be presented at a scientific conference later in 2019.

Comment:Previous late-stage studies of abicipar showed inflammation rates of about 15%, but even the improved rate in MAPLE study at an 8.9% incidence rate of intraocular inflammation is still higher than what multiple analysts considered competitive.