Opthea Limited, a clinical-stage biopharmaceutical company, has achieved a significant milestone by completing patient enrolment in its two pivotal Phase 3 trials, COAST and ShORe, evaluating sozinibercept for wet age-related macular degeneration (wet AMD).
The global Phase 3 program enrolled a total of 1,984 treatmentnaïve wet AMD patients across the two trials, making it one of the largest Phase 3 programs in wet AMD. Both studies are assessing the efficacy and safety of intravitreal sozinibercept 2.0 mg in combination with standardof- care anti-vascular endothelial growth factor-A (anti-VEGF-A) therapies aflibercept (COAST) or ranibizumab (ShORe), compared to standard of care alone. The primary endpoint is mean change in best corrected visual acuity from baseline to week 52.
Sozinibercept is the first novel wet AMD therapeutic in over 15 years targeting improved visual outcomes when combined with anti-VEGF-A standard of care. By inhibiting VEGF-C and VEGF-D, which drive retinal angiogenesis and vascular leakage, sozinibercept may prevent blood vessel growth and leakage contributing to wet AMD pathophysiology.
Dr Arshad Khanani, Chief Medical Advisor of Opthea, said completing enrolment for the sozinibercept global Phase 3 clinical trial program “brings us closer to our goal of improving visual outcomes for patients with wet AMD. 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 large, global Phase 3 clinical program,” he said.
Pivotal 52-week data is expected in mid-2025 to support a potential regulatory submission.
