The anti-VEGF abicipar pegol was similarly efficacious in treating neovascular age-related macular degeneration as ranibizumab, meeting the primary endpoint of non-inferiority in two phase 3 clinical trials, Allergan and Molecular Partners announced in a press release.
After six or eight injections, abicipar, a DARPin molecule, demonstrated similar efficacy as 13 injections of Lucentis (ranibizumab, Genentech) in both the CEDAR and SEQUOIA trials after the first year. Both trials were multicenter, randomized studies that evaluated the efficacy and safety of abicipar in patients with neovascular AMD.
In the first arm (Q8) of each trial, patients received 2 mg abicipar in three monthly doses followed by a dose every 8 weeks, and the second arm (Q12) received 2 mg in two monthly doses, followed by a dose after 8 weeks and then dosing every 12 weeks. The third arm received 0.5 mg ranibizumab monthly doses for 13 months.
The proportion of patients with stable vision in the SEQUOIA study was 94.8% in the Q8 arm and 91.3% in the Q12 arm compared with 96% in the ranibizumab arm, the release said.
In the CEDAR study, the Q8 arm had a 91.7% proportion of stable vision, while those in the Q12 arm had 91.2% compared with 95.5% in the ranibizumab arm.
In both studies, rates of overall treatment-emergent adverse events were similar in the three treatment arms. The incidence of intraocular inflammation events was similar in the abicipar arms but was higher than that reported in the ranibizumab arm.
A filing for abicipar is planned for 2019, the release said, with Allergan seeking a meeting with the FDA regarding a biologics license application submission.