Opthea’s COAST Trial Reaches Critical Milestone: Week 52 Patient Visit Completed

About Opthea Limited

Opthea Limited (ASX: OPT), a Melbourne-based clinical-stage biopharmaceutical company, is advancing sozinibercept, a first-in-class VEGF-C/D inhibitor, through Phase 3 trials for wet age-related macular degeneration (wet AMD). With the potential to become the first new wet AMD therapy in over two decades, sozinibercept targets a multi-billion-dollar global market. Dual-listed on the ASX and NASDAQ, Opthea is supported by FDA Fast Track Designation, positioning it as a leader in innovative retinal disease treatments with significant growth potential for investors.

Growth Pipeline and Operations

Opthea’s COAST and ShORe Phase 3 trials are pivotal to its growth strategy, evaluating sozinibercept combined with aflibercept (COAST) or ranibizumab (ShORe) against standard anti-VEGF-A monotherapy. The completion of the Week 52 patient visit in COAST marks a critical milestone, bringing the company closer to delivering potentially transformative results for wet AMD treatment. This achievement underscores Opthea’s progress in advancing a therapy that could redefine the standard of care for retinal diseases.

The primary endpoint measures the mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 52, a key indicator of treatment efficacy. Patients will continue treatment for an additional year to assess long-term safety, highlighting Opthea’s commitment to addressing the chronic nature of wet AMD and ensuring durable patient outcomes. This extended evaluation period also strengthens the robustness of the clinical data, which could support regulatory approvals.

Opthea’s financial prospects are closely tied to the success of its Phase 3 trials, with the wet AMD market valued in the billions and dominated by anti-VEGF therapies like aflibercept and ranibizumab. A successful outcome could position Opthea to capture a significant share of this lucrative market, particularly if sozinibercept demonstrates superior efficacy over existing treatments. This potential market penetration could translate into substantial revenue growth and long-term shareholder value.

The FDA’s Fast Track Designation for sozinibercept accelerates regulatory review and enhances its appeal to investors by highlighting its potential to address a critical unmet need in wet AMD treatment. This designation not only streamlines the approval process but also validates the therapy’s innovative approach, making Opthea an attractive prospect for both institutional and retail investors.

Opthea’s Phase 3 program aims to secure a broad label for sozinibercept, enabling its use with any anti-VEGF-A therapy, which maximises market potential and addresses a significant gap in wet AMD treatment options. This strategic flexibility allows Opthea to target a wider patient population and collaborate with existing therapies, enhancing its competitive edge in the ophthalmology sector.

The global wet AMD market is projected to grow at a 7.5% CAGR from 2023 to 2030, driven by ageing populations and increasing disease prevalence. Sozinibercept’s unique mechanism of action—targeting VEGF-C/D alongside VEGF-A—positions Opthea as a potential disruptor in the ophthalmology space, offering a differentiated solution that could set a new benchmark in retinal disease treatment. This innovation aligns with growing demand for advanced therapies that deliver superior clinical outcomes.

The Road Ahead: A Transformative Opportunity

Opthea’s completion of the Week 52 patient visit in the COAST trial marks a pivotal step toward delivering potentially groundbreaking results in early 2025. With sozinibercept poised to address a significant unmet need in wet AMD treatment, the company is well-positioned to revolutionise the ophthalmology landscape and improve the lives of millions of patients worldwide. As Opthea advances its Phase 3 program, the potential for sozinibercept to become the first new wet AMD therapy in two decades presents a compelling opportunity for investors. Backed by FDA Fast Track Designation and a robust clinical strategy, Opthea is on track to solidify its position as a leader in retinal disease treatments, offering significant growth potential in a multi-billion-dollar market.