Allergan, Molecular Partners’ abicipar has shown non-inferiority to Novartis’ Lucentis but with fewer injections in late-stage trials involving patients with neovascular age-related macular degeneration.
The Phase III SEQUOIA and CEDAR trials demonstrated that both the eight-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to Lucentis (ranibizumab) in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
The primary endpoint measured the proportion of treated patients with stable vision at week 52.
In both studies, the drug showed similar efficacy after six or eight injections, compared to 13 Lucentis injections in the first year of this study.
The firms said overall adverse events were similar among the three treatment arms, but that the incidence of intraocular inflammation was higher in patients treated with abicipar than those given Lucentis.
“We believe the SEQUOIA and CEDAR studies demonstrated what we set out to achieve, strong efficacy and duration of effect which shows the potential of abicipar as a treatment for AMD patients,” noted David Nicholson, chief research and development officer.
“We have generated important findings in these trials to address a serious unmet need. We will continue to review these data including inflammation findings and are working on further optimising the abicipar formulation."
“Abicipar could be the first and only 12- week anti-VEGF treatment that improves visual outcomes in a real world setting for a large number of AMD patients," added Raj Maturi, MD, Midwest Eye Institute & Associate Professor Ophthalmology, Indiana University School of Medicine.
The filing for abicipar is planned for the first half of 2019.