Two Phase III trials, SEQUOIA and CEDAR for abicipar both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab.- Allergan + Molecular Partners

Allergan plc and Molecular Partners a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, announced the release of two positive clinical trials, SEQUOIA and CEDAR for abicipar, demonstrating that both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. SEQUOIA and CEDAR are identical global phase III studies designed to assess the efficacy and safety of abicipar compared with 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 abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study. The overall adverse events were similar among the three treatment arms. The incidence of intraocular inflammation was higher in the abicipar arms compared to ranibizumab-treated patients in both trials. We are further analyzing these results. SEQUOIA and CEDAR clinical trials continue on a masked basis for a second year.

In the SEQUOIA study, the proportion of patients with stable vision in abicipar dosed Q8 was 94.8 percent, in Q12 was 91.3 percent compared to ranibizumab dosed Q4 96.0 percent. In CEDAR, the proportion of patients with stable vision in the abicipar dosed Q8 was 91.7 percent, in Q12 was 91.2 percent compared to ranibizumbab dosed Q4 95.5 percent.

In the SEQUOIA study, overall treatment-emergent adverse events were similar among the 3 treatment arms, reported in 78.3 percent, 78.0 percent and 74.0 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than the ranibizumab arm and reported at 15.7 percent and 15.3 percent of patients in the abicipar Q8 and Q12 arms compared to 0.6 percent in the ranibizumab Q4 arm.

In the CEDAR study, overall treatment-emergent adverse events were similar among the 3 treatment arms reported in 73.7 percent, 81.1 percent and 73.2 percent of patients receiving abicipar Q8, abicipar Q12 and ranibizumab Q4, respectively. Incidence of intraocular inflammation events was similar among the two abicipar treatment groups but higher than ranibizumab arm and reported at 15.1 percent and 15.4 percent of patients in the abicipar Q8 and Q12 arms compared to 0 percent in the ranibizumab Q4. Allergan is continuing to review these data. The full data details of the primary endpoints and the secondary endpoints will be presented at an upcoming scientific conference.