Opthea Completes Patient Enrollment for Phase 3 Trial on Wet AMD

Opthea has reached a significant milestone in its quest to combat wet age-related macular degeneration (AMD) with the completion of patient enrollment in the COAST phase 3 pivotal clinical trial. The trial investigates sozinibercept (OPT-302), a promising vascular endothelial growth factor (VEGF)-C/D inhibitor, in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet AMD.

According to a recent company announcement, Opthea has successfully enrolled all patients for the COAST trial, marking a crucial step forward in the clinical development of sozinibercept.

Frederic Guerard, PharmD, Chief Executive Officer of Opthea, emphasized the significance of this achievement, stating, " Completion of patient enrollment in our first pivotal trial marks an important milestone in the development of sozinibercept for the treatment of wet AMD. We believe sozinibercept has the potential to provide superior clinical results, based on the strength of our phase 2b trial, which demonstrated a statistically significant improvement in visual acuity for patients treated with sozinibercept combined with Lucentis (ranibizumab) compared to ranibizumab alone."

Opthea's sozinibercept clinical program comprises two phase 3 pivotal trials: COAST and ShORe. While enrollment in the COAST trial has been concluded, enrollment for the ShORe trial is expected to wrap up in the second quarter of 2024. Opthea aims to unveil topline results from both trials by mid-2025, with high hopes pinned on the potential of sozinibercept to deliver superior clinical outcomes.

Sozinibercept, also known as OPT-302, is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It targets VEGF-C and VEGF-D, neutralizing their activity on endogenous receptors, which is pivotal in preventing blood vessel growth and vascular leakage associated with retinal diseases like wet AMD. Notably, sozinibercept has garnered Fast Track Designation from the FDA for the treatment of wet AMD.

The COAST and ShORe phase 3 clinical trials are being conducted simultaneously on a global scale to evaluate the efficacy and safety of sozinibercept in combination with standard anti-VEGF-A treatments. Both trials aim to demonstrate the superiority of combination therapy versus standard of care, with primary endpoints focused on mean change in best corrected visual acuity (BCVA) from baseline to week 52. Additionally, each trial will evaluate the use of sozinibercept treatment dosed every 4 weeks and every 8 weeks after the first three loading doses.