Opthea Completes Week 52 Patient Visits in COAST Phase 3 Trial for Wet AMD
Opthea Limited has reached a significant milestone in its COAST Phase 3 clinical trial, completing the final week 52 patient visits. COAST is one of two pivotal studies evaluating the efficacy and safety of sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe) compared to anti-VEGF monotherapy for the treatment of wet age-related macular degeneration (wet AMD).
Advancing Wet AMD Treatment with Sozinibercept
Topline COAST trial results are expected in early Q2 2025, while data from the ShORe trial is anticipated in mid-2025.
"The completion of the final week 52 patient visit in COAST is an important milestone in the development of sozinibercept, as we deliver on our mission of improving visual outcomes in patients with wet AMD to enable fuller and healthier lives," said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. "I would like to thank Charles Wykoff, MD, PhD, as well as all COAST investigators and clinical staff, for their dedication as we prepare to announce the topline data in early Q2 2025."
Key Aspects of the Phase 3 Program
Opthea’s Phase 3 trials are designed to demonstrate the superiority of sozinibercept combination therapy over standard-of-care anti-VEGF-A monotherapy.
Study Overview:
• COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab)
• Primary Endpoint: Mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52
• Extended Evaluation: Patients will continue treatment for an additional year, assessing long-term safety and tolerability over a two-year period
Potential for Broad Label Approval
Opthea aims for sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients, supporting a broad label indication.
Sozinibercept has also received Fast Track Designation from the U.S. FDA, reinforcing its potential as a groundbreaking therapy for wet AMD.
With the completion of week 52 visits in COAST, Opthea moves closer to providing an innovative treatment option that could enhance visual outcomes and improve patient care in wet AMD.
