Opthea completes patient enrollment in pivotal trials for wet AMD, highlights progress in Phase 3.
From GlobeNewswire: 2024-08-30 07:30:00
Opthea Limited completed patient enrollment in COAST and ShORe pivotal wet AMD trials, securing finances to reach topline data by 2025. New leadership appointments were made in preparation for regulatory filing and launch of sozinibercept. Opthea highlighted significant progress in advancing their Phase 3 program for wet AMD, with expected Phase 3 topline results in early Q2 2025 for COAST and mid-2025 for ShORe. They completed enrollment in one of the largest Phase 3 programs for wet AMD, raised nearly US$300 million in financing, and made key leadership appointments to support the development and launch of sozinibercept. Opthea presented evidence showcasing the potential for sozinibercept to be the first therapy in 20 years to improve visual outcomes in wet AMD patients. They also formed a Medical Advisory Board and reported financial results for the fiscal year ended June 30, 2024. Opthea reported a net loss of US$220.2 million, an increase of 55% from the previous year, with substantial cash and cash equivalents totaling US$172.5 million as of June 30, 2024. Opthea is scheduled to participate in various investor and medical conferences in September 2024. Sozinibercept, a first-in-class VEGF-C/D inhibitor, has shown promise in combination with anti-VEGF-A therapies to improve vision in patients with wet AMD, potentially leading to improved quality of life. Opthea’s Phase 3 clinical program is fully enrolled and aims to assess the safety and efficacy of sozinibercept combination therapy compared to standard anti-VEGF-A therapies. With Fast Track Designation from the US FDA, Opthea’s innovative therapy has the potential to provide significant benefits for patients with wet AMD. Opthea’s prospective Phase 2b clinical trial yielded positive outcomes, demonstrating the potential of sozinibercept to significantly improve visual outcomes in patients with wet AMD.
Read more at GlobeNewswire:: Opthea Reports Full-Year Financial Results and Business