Opthea Completes COAST Final Week 52 Patient Visit

Core Insights - Opthea Limited has completed the final week 52 patient visit in the COAST Phase 3 trial, which evaluates the superiority and safety of sozinibercept combined with aflibercept for treating wet AMD [1][2] - Topline results from the COAST trial are expected in early Q2 CY25, while results from the ShORe trial are anticipated in mid-CY25 [1][2] Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, particularly wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) [3] - The lead product candidate, sozinibercept, is a first-in-class VEGF-C/D 'trap' inhibitor aimed at providing superior vision outcomes for wet AMD patients [4] Clinical Trials - Opthea is conducting two pivotal Phase 3 trials: COAST (combination of OPT-302 with Aflibercept) and ShORe (combination of OPT-302 with Ranibizumab) [2] - The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 [2] - Patients will continue treatment for an additional year post-week 52 to assess extended safety and tolerability [2] Regulatory Status - Sozinibercept has received Fast Track Designation from the US FDA for the treatment of wet AMD, which may facilitate its development and approval process [2]