Future in doubt as Opthea’s AMD drug flunks first pivotal study
Opthea's future is in jeopardy after its lead drug candidate sozinibercept failed to meet the primary endpoint in the COAST Phase 3 trial for wet age-related macular degeneration (AMD)23. The study evaluated sozinibercept in combination with aflibercept compared to aflibercept alone2.
Key details:
-
Patients receiving sozinibercept combination therapy showed no significant improvement in visual acuity compared to aflibercept monotherapy at 52 weeks23.
-
The failure raises concerns about Opthea's ability to continue as a going concern23.
-
Opthea may be obligated to repay up to $680 million to investors under a 2022 Development Funding Agreement, threatening its solvency23.
-
The company is considering the impact on its other ongoing Phase 3 trial (ShORe) and discussing options with investors6.
-
Opthea had $113.8 million in cash as of February 2025 but faces material uncertainty about its ability to continue operations6.
-
Trading of Opthea's stock has been halted on both the Australian and Nasdaq exchanges while the company determines next steps3.
This setback is a major blow to Opthea, which had positioned sozinibercept as a potential blockbuster therapy for wet AMD2. The company's future now depends heavily on negotiations with creditors and decisions regarding its remaining clinical program3.
Sources:
2. https://www.finnewsnetwork.com.au/archives/financenewsnetwork1192119.html
3. https://www.fiercebiotech.com/biotech/optheas-eye-drug-defeated-eylea-phase-3-leaving-biotech-mull-future
6. https://ir.opthea.com/news-releases/news-release-details/opthea-announces-coast-phase-3-trial-topline-results