Opthea Nears Pivotal Data Readout, Risks Loom in Wet AMD Drug Race
Opthea has completed the final patient visit in its pivotal COAST Phase 3 trial evaluating sozinibercept combined with aflibercept for wet AMD, with topline results expected early Q2 2025.
- Final week 52 patient visit completed in COAST Phase 3 trial
- Trial tests sozinibercept plus aflibercept versus standard care in wet AMD
- Topline results anticipated in early Q2 calendar year 2025
- Concurrent ShORe trial with ranibizumab ongoing, results mid-2025
- Sozinibercept holds FDA Fast Track designation for wet AMD
Completion of a Key Clinical Milestone
Opthea Limited, a clinical-stage biopharmaceutical company focused on retinal diseases, has announced the completion of the final week 52 patient visit in its COAST Phase 3 trial. This trial is the first of two pivotal studies assessing the efficacy and safety of sozinibercept in combination with aflibercept for the treatment of wet age-related macular degeneration (wet AMD).
The COAST trial aims to demonstrate the superiority of this combination therapy over the current standard of care, which typically involves anti-VEGF-A monotherapy. Completion of the final patient visit marks a significant step forward in Opthea’s development program, bringing the company closer to delivering potentially transformative treatment options for patients suffering from this vision-threatening condition.
Trial Design and Expectations
The COAST study evaluates the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52, comparing the combination of sozinibercept and aflibercept against aflibercept alone. Patients will continue to be monitored for an additional year post-week 52 to assess extended safety and tolerability over a two-year period.
Alongside COAST, Opthea is conducting the ShORe trial, which investigates sozinibercept combined with ranibizumab. While COAST topline results are expected in early Q2 2025, ShORe results are anticipated by mid-2025. Both trials are designed to support a broad label, potentially enabling sozinibercept to be approved for use with any anti-VEGF-A therapy in wet AMD patients.
Strategic Implications and Market Potential
Sozinibercept is a first-in-class VEGF-C/D 'trap' inhibitor, representing a novel mechanism of action in the treatment landscape of wet AMD. The therapy’s potential to improve visual outcomes beyond current standards could position Opthea as a key player in a market that has seen little innovation in two decades.
The drug has already received Fast Track Designation from the US FDA, underscoring its potential clinical importance. If the Phase 3 trials confirm superiority and safety, sozinibercept could redefine treatment paradigms and offer patients a chance at fuller, healthier lives.
Risks and Forward-Looking Considerations
Despite the promising progress, Opthea’s announcement includes the usual caveats associated with clinical development. The inherent risks of drug development, regulatory approvals, and market acceptance remain. Investors should weigh these factors carefully, especially given the speculative nature of biotechnology ventures.
Nonetheless, the completion of the COAST trial’s final patient visit is a tangible milestone that sets the stage for a critical data readout in the coming months. The industry will be watching closely to see if sozinibercept can deliver on its promise.
Bottom Line?
With COAST’s final patient visit behind it, Opthea now shifts focus to pivotal topline data that could reshape wet AMD treatment.
Questions in the middle?
- Will the COAST trial demonstrate statistically significant superiority over standard care?
- How will the ShORe trial results compare, and what implications will they have for sozinibercept’s label?
- What are the commercial strategies Opthea will pursue if both trials meet their endpoints?
