Two year data from CEDAR and SEQUOIA studies of abicipar pegol to treat neovascular (wet) age-related macular degeneration.-Allergan + Molecular Partners.

Allergan plc,and Molecular Partners a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, announced two-year data from the CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular (wet) age-related macular degeneration (nAMD). 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 III studies designed to assess the efficacy and safety of Abicipar 8-week and 12-week treatment regimens compared with monthly ranibizumab in treatment-na�ve patients with nAMD. Allergan previously announced that Abicipar met the prespecified primary end point of the proportion of patients with stable vision at week 52 demonstrating non-inferiority 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 III 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.

Mean changes in best-corrected visual acuity (BCVA) seen in year two were similar when compared to year one across all treatment arms. Central retinal thickness (CRT) continued to decrease during year two when compared to year one. 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 two were comparable between treatment groups. The pooled rate of new cases of intraocular inflammation in year two for patients who received Abicipar in the 8-and 12-week arms was 1.9%, which is similar to the ranibizumab arm of 1%.