- Opthea Limited completed the final week 52 patient visit in COAST and ShORe, two phase III pivotal trials for wet AMD treatment.
- The primary endpoint for both trials 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.
- Patients will be treated for an additional year beyond week 52 to assess extended safety and tolerability.
- With the FDA's Fast Track Designation, Opthea's phase III program aims to enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients.
- The topline results from both trials are expected in early and mid-CY25.
Source: Ophthalmology Management