Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Wet AMD
Allergan and Molecular Partners announced 2-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with wet age-related macular degeneration (AMD). In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable to monthly ranibizumab. These data were presented as a late-breaking oral presentation during Retina Subspecialty Day at the Annual Meeting of the American Academy of Ophthalmology (AAO).
CEDAR and SEQUOIA are identical global phase 3 studies designed to assess the efficacy and safety of Abicipar 8-week and 12-week treatment regimens compared with monthly ranibizumab in treatment-naïve patients with wet AMD. Allergan previously announced that Abicipar met the prespecified primary end point of the proportion of patients with stable vision at week 52 demonstrating noninferiority in both the 8-week and 12-week treatment regimens compared to monthly ranibizumab.
Through week 104, patients received Abicipar 2 mg every 8-weeks or every 12-weeks or ranibizumab 0.5 mg every 4 weeks. At week 104 in the pooled phase 3 data, the proportion of patients with stable vision was 93%, 90% and 94% in 8-week Abicipar; 12-week Abicipar and 4-week ranibizumab treatment regimens, respectively. This continuation of stable vision in year 2 further reinforces the ability of Abicipar to deliver consistent quarterly dosing for the majority of patients.
“Current anti-VEGF treatments for neovascular age-related macular degeneration require frequent intravitreal injections,” Rahul N. Khurana, MD, Northern California Retina Vitreous Associates Medical Group, said in a company news release. “Based on the results of CEDAR and SEQUOIA, which reinforce the efficacy of Abicipar while decreasing the number of injections, Abicipar could transform anti-VEGF treatment regimens.”
Mean changes in best-corrected visual acuity (BCVA) seen in year 2 were similar when compared to year 1 across all treatment arms. Central retinal thickness (CRT) continued to decrease during year 2 when compared to year 1. CRT for patients treated with Abicipar dosed quarterly and every 8-weeks were similar to ranibizumab dosed every 4 weeks through week 104. Overall incidence rates of treatment-emergent adverse events at the end of year 2 were comparable between treatment groups. The pooled rate of new cases of intraocular inflammation in year 2 for patients who received Abicipar in the 8-and 12-week arms was 1.9%, which is similar to the ranibizumab arm of 1%.
“These late-breaking data further demonstrate the potential of Abicipar to provide consistent quarterly dosing that sustains vision gains in the majority of patients with neovascular age-related macular degeneration,” David Nicholson, Chief Research and Development Officer, Allergan, said in the news release. “On the heels of regulatory filings for Abicipar in the United States and European Union, these data give us confidence in our ability to meet a serious unmet need for patients and eye doctors.”
“We are very excited at the continued success of Abicipar, our most advanced DARPin molecule, in the treatment of patients with neovascular age-related macular degeneration,” Patrick Amstutz, PhD, CEO of Molecular Partners, said in the news release. “We are pleased to see a sustained response at 2-years with less frequent dosing of Abicipar compared to standard of care therapy.”
The FDA and European Medicines Agency (EMA) are currently reviewing regulatory applications for Abicipar in patients with wet AMD. The FDA is expected to take action on the BLA in mid-2020. A decision from the European Commission is expected in the second half of 2020.