Opthea completes enrollment in Phase 3 clinical program with sozinibercept

Opthea has now completed enrollment in both the COAST and ShORe trials constituting its pivotal Phase 3 clinical program. This program is designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies compared to standard of care alone for the treatment of patients with wet AMD. Opthea’s Phase 3 clinical program consists of two multicenter, double-masked, randomized, sham-controlled trials COAST and ShORe, which enrolled 1,984 treatment-naive wet AMD patients in total, making it one of the largest Phase 3 programs in wet AMD. Both Phase 3 trials combine sozinibercept with standard-of-care anti-VEGF-A therapy to assess the efficacy and safety of intravitreal 2.0 mg sozinibercept in combination with 2.0 mg aflibercept, or 0.5 mg ranibizumab, compared to standard of care alone. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52. Both trials are also evaluating the safety and tolerability over a two-year period.