Opthea Limited has announced the completion of the final week 52 patient visit in its Phase 3 COAST trial, evaluating sozinibercept in combination with aflibercept for the treatment of wet age-related macular degeneration (AMD). The company anticipates topline results from the COAST trial in early Q2 CY25, with results from the ShORe trial expected in mid-CY25.
COAST Trial Details
The COAST (Combination OPT-302 with Aflibercept Study) trial is a pivotal study designed to assess the superiority and safety of sozinibercept when used in conjunction with aflibercept, compared to the standard of care alone for wet AMD. Frederic Guerard, PharmD, CEO of Opthea, expressed enthusiasm for the milestone, stating, "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."
The trial enrolled 998 treatment-naive patients with neovascular AMD, evaluating sozinibercept administered every four weeks (Q4W) with aflibercept every eight weeks (Q8W), aflibercept Q8W with sozinibercept Q8W, and aflibercept Q8W plus sham Q4W.
ShORe Trial and Primary Endpoint
Opthea is also conducting the ShORe (Study of OPT-302 in combination with Ranibizumab) trial, which has completed enrollment of 986 treatment-naive patients with wet AMD. This trial assesses the combination of sozinibercept with ranibizumab. The primary endpoint for both the COAST and ShORe trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy.
Sozinibercept: A Novel VEGF-C/D Inhibitor
Sozinibercept is a first-in-class VEGF-C/D inhibitor being developed by Opthea as a potential adjunctive therapy to standard anti-VEGF-A treatments. By targeting VEGF-C and VEGF-D, sozinibercept aims to address a different pathway in the pathogenesis of wet AMD, potentially offering improved outcomes compared to existing therapies. The US FDA has granted Fast Track Designation to sozinibercept for wet AMD, underscoring the unmet need in this patient population.
Potential Impact on Wet AMD Treatment
If successful, Opthea's Phase 3 program is designed to support a broad label, potentially allowing sozinibercept to be used in combination with any anti-VEGF-A therapy for wet AMD patients. According to Opthea, sozinibercept has the potential to become the first therapy in 20 years to enable patients with wet AMD live fuller and healthier lives.
