Official websites use. Share sensitive information only on official, secure websites. These trials were designed to evaluate patients randomized to receive faricimab 6. The initial doses in the faricimab arm were followed by individualized fixed treatment intervals up to week 60, based on disease activity assessment at weeks 20 and 24, guided by central subfield thickness, best-corrected visual acuity BCVA , and investigator assessment.
The primary efficacy end point was BCVA change from baseline averaged over weeks 40, 44, and Secondary end points included the proportion of patients receiving everyweek, everyweek, and everyweek faricimab and anatomic outcomes. Safety outcomes included incidence and severity of ocular and nonocular adverse events. The PTI approach was designed to tailor treatment intervals to individual patient needs, to reflect clinical practice treatment practice, and to reduce treatment burden.
The innovative trial design rationale for the TENAYA and LUCERNE trials included maximizing the benefits of angiopoietin-2 blockade through dosing up to every 16 weeks and PTI regimens based on patients' disease activity while fulfilling health authority requirements for potential registrational efforts. Neovascular age-related macular degeneration nAMD , characterized by abnormal growth of blood vessels into the macula, affecting the outer retina, and impacting photoreceptor integrity, is a leading cause of irreversible vision loss globally in adults 50 years of age and older if left untreated.
Because of the multifactorial nature of nAMD and despite tremendous achievement in treatment outcomes, underlying pathologic mechanisms associated with nAMD progression remain, such as vascular leakage and inflammation, that may not be addressed with intravitreal anti-VEGF monotherapy and that may lead to long-term detrimental effects on vision.
Faricimab is a novel humanized bispecific immunoglobulin G1 monoclonal antibody designed for intraocular use that independently binds and neutralizes both angiopoietin-2 and VEGF-A. The week AVENUE trial established the efficacy and safety of faricimab compared with ranibizumab, 29 and the week STAIRWAY trial demonstrated sustained efficacy through extended durability of faricimab on fixed everyweek and everyweek dosing, with comparable vision and anatomic gains versus everyweek ranibizumab.
