Allergan plc AGN and partner Molecular Partners announced top-line safety data from the phase III MAPLE study on its long-acting anti-VEGF product, abicipar pegol in age-related neovascular macular degeneration (nAMD)
MAPLE, a 28 week open-label study, used a modified manufacturing process to test an optimized 12-week formulation of abicipar in nAMD patients Following the improved manufacturing process, it was observed that the incidence of intraocular inflammation (IOI) in the study was lower than previous phase III studies. In the MAPLE study, the reported incidence of IOI was 8.9%, which was less than around 15% observed in the previous studies, SEQUOIA and CEDAR. Meanwhile, the incidence of severe IOI events was also less. Importantly, there were no cases of inflammation complications like endophthalmitis or retinal vasculitis in the study.
Last July, Allergan and Molecular Partners announced data from two phase III studies - SEQUOIA and CEDAR - evaluating abicipar compared with Novartis NVS/Roche’s RHHBY Lucentis (ranibizumab) in treatment-naïve patients with nAMD. Data from the studies demonstrated that treatment with both the 8-week and 12-week regimens of abicipar resulted in a higher percentage of patients achieving stable vision at week 52 (primary endpoint), thereby demonstrating non-inferiority to Lucentis.
The companies plan to file a biologics license application (BLA) for abicipar in the first half of 2019.If approved as a fixed 12- week anti-VEGF treatment for nAMD, it will reduce the treatment burden for these patients. Detailed safety data from the MAPLE study are expected to be presented later this year. Allergan also said it plans to move forward with a phase III study on abicipar for diabetic macular edema (DME) in the second half of the year
Please note that Regeneron Pharmaceuticals REGN is also seeking approval for a 12-week dosing interval of its blockbuster anti-VEGF drug Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
Allergan’s stock was down slightly on Tuesday after the news was announced as MAPLE study’s inflammation rates were still too high compared to those observed in studies on Lucentis and Eylea. Allergan’s share price has risen 9.4% this year so far compared with the industry’s increase of 10.5%.
Allergan currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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