Opthea (ASX:OPT) has announced that it has completed the enrolment of all patients in the COAST Phase 3 pivotal clinical trial investigating sozinibercept in combination with aflibercept.
Sozinibercept (OPT-302), is a vascular endothelial growth factor (VEGF)-C/D inhibitor, and aflibercept is an anti-VEGF-A therapy. The trial will study the therapies for the treatment of wet Age-related Macular Degeneration (wet AMD).
The sozinibercept clinical program includes two Phase 3 pivotal trials, COAST and ShORe.
Enrolment in ShORe is expected to be completed in the second quarter of the calendar year 2024. Opthea said it intends to report topline results from these two trials by mid-2025.
“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,” said Opthea CEO Frederic Guerard.
“We look forward to maintaining this positive momentum and completing enrollment in the ShORe pivotal trial in calendar Q2 2024, with a goal of communicating topline results for both trials by mid-2025.”
