Opthea Limited’s Phase 3 COAST trial for sozinibercept, a combination therapy with aflibercept for wet age-related macular degeneration (wet AMD), failed to meet its primary endpoint of improved best corrected visual acuity (BCVA). The trial showed no significant difference in BCVA improvement between patients receiving sozinibercept combined with aflibercept and those receiving aflibercept alone. This negative result triggers potential financial obligations under Opthea’s Development Funding Agreement (DFA) and casts doubt on the company’s ability to continue operating.
This failed trial is a significant setback for Opthea and potentially impacts the wet AMD treatment landscape. Sozinibercept was a promising candidate that aimed to improve upon the current standard of care, offering the possibility of better vision outcomes for patients. The negative results not only halt the drug’s development but also raise questions about the viability of targeting this specific biological pathway for wet AMD treatment. This could lead to a shift in research and development focus within the industry.
The COAST trial involved various dosing regimens of sozinibercept in combination with aflibercept, compared to aflibercept monotherapy. None of the sozinibercept combinations demonstrated a statistically significant improvement in BCVA. Opthea’s financial situation is now precarious due to the DFA. The company may be obligated to repay substantial sums to investors, potentially exceeding its current cash reserves. Opthea’s assets are secured by the DFA investors, limiting the company’s options for raising additional funds.
The future of Opthea is uncertain. The company is in discussions with DFA investors to explore potential options, including negotiated settlements or alternative development paths. However, the company acknowledges a material uncertainty regarding its ability to continue as a going concern. The outcome of these discussions will determine whether Opthea can restructure its operations, secure further funding, or potentially face insolvency. The failure of the COAST trial represents a substantial hurdle for the company and highlights the inherent risks in pharmaceutical development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
