Opthea Limited completed the final week 52 patient visit in COAST, the first of 2 Phase 3 pivotal trials investigating the superiority and safety of sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe), compared to standard of care alone for the treatment of wet AMD. The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe), the company said in a press release. 

Opthea is conducting two concurrent global pivotal phase 3 clinical trials for the treatment of wet AMD, aiming to demonstrate superiority of sozinibercept combination therapy vs standard of care alone: COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab). The primary endpoint for both trials is the mean change in best-corrected visual acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy, the company said. 

Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability up to a 2-year period. According to the company, Opthea’s phase 3 program is designed to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients. Sozinibercept has received Fast Track Designation from the US Food and Drug Administration for the treatment of wet AMD.