Opthea Limited completed enrollment in both the COAST and ShORe trials constituting its pivotal Phase 3 clinical program. The 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, the company stated in a press release. 

In a large Phase 2b clinical trial of 366 treatment-naïve wet AMD patients, sozinibercept demonstrated strong clinical evidence of superior visual outcomes in combination with ranibizumab. These data formed the basis for this global Phase 3 clinical program, the company said.

Opthea’s Phase 3 clinical program consists of two multicenter, double-masked, randomized, sham-controlled trials COAST (combination OPT-302 with aflibercept study) and ShORe (study of OPT-302 in combination with ranibizumab), which enrolled 1,984 treatment-naïve wet AMD patients in total (998 patients in COAST; 986 patients in ShORe). 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 (COAST) or 0.5 mg ranibizumab (ShORe), compared to standard of care alone. The primary endpoint for both trials is the mean change in BCVA from baseline to week 52. Both trials are also evaluating the safety and tolerability over a 2-year period.

Pivotal 52-week topline data is expected in mid-CY2025 to support a potential Biologic License Application submission, the company said.