Sozinibercept Topline Results Expected in Q2 After COAST Trial Completion

Opthea has concluded the final week 52 patient visit in the pivotal Phase 3 COAST trial investigating the superiority and safety of sozinibercept in combination with aflibercept for patients with neovascular (wet) age-related macular degeneration (nAMD).1

Announced on February 18, 2025, the COAST (Combination OPT-302 with Aflibercept Study) trial is expected to report topline results for sozinibercept for nAMD in early Q2 of this year.

“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.

Opthea’s lead product candidate is a first-in-class VEGF-C/D inhibitor being assessed in combination with standard-of-care anti-vascular endothelial growth factor A (VEGF-A) therapies for the treatment of wet AMD. The company indicated that sozinibercept could become the first therapy in nearly two decades to improve visual outcomes in wet AMD in combination with anti-VEGF monotherapies.2

COAST is the first of two pivotal Phase 3 trials concurrently evaluating the efficacy and safety of sozinibercept for wet AMD. The ShORe (Study of OPT-302 in combination with Ranibizumab) trial assesses the superiority and safety of sozinibercept in combination with ranibizumab, compared with standard-of-care monotherapy, for wet AMD.

The COAST Trial completed enrollment with 998 treatment-naive patients with nAMD. The trial evaluated sozinibercept every 4 weeks (Q4W) with aflibercept every 8 weeks (Q8W), aflibercept Q8W with sozinibercept Q8W, and aflibercept Q8W plus sham Q4W.

ShORe also completed the enrollment of 986 treatment-naive patients with wet AMD. The trial evaluated ranibizumab Q4W and sozinibercept Q4W, ranibizumab Q4W and sozinibercept Q8W, and ranibizumab Q4W plus sham Q4W.

The primary endpoint for each trial is the mean change in best-corrected visual acuity (BCVA) from baseline to Week 52 for sozinibercept combination therapy, compared with anti-VEGF-A monotherapy. After Week 52, patients will continue to be treated for an additional year to determine the extended safety and tolerability of up to 2 years.2

The US Food and Drug Administration (FDA) has previously granted Fast Track Designation to sozinibercept for wet AMD. Opthea indicated the Phase 3 program supports a broad label, and if successful, sozinibercept could be approved for use alongside any anti-VEGF-A therapy in wet AMD.

“I would like to thank Charles Wykoff, MD, PhD, as well as all of the COAST investigators and their clinical staff for their excellent work as we plan to announce the anticipated topline data in early Q2 CY25,” Guerard added.1

References

1. Opthea completes Coast Final Week 52 patient visit. Opthea Limited, Inc. February 18, 2025. Accessed February 19, 2025. https://ir.opthea.com/news-releases/news-release-details/opthea-completes-coast-final-week-52-patient-visit-0.

2. Clinical trials. Opthea. July 5, 2024. Accessed February 19, 2025. https://opthea.com/clinical-trials/#phase-3.