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Opthea Announces Termination of ShORe and COAST Trials of Sozinibercept
The treatment for wet age-related macular degeneration failed to achieve its primary endpoint in both trials.
Sozinibercept, a novel vascular endothelial growth factor (VEGF) “trap” fusion protein intended for use treating wet age-related macular degeneration (AMD), failed to demonstrate the vision improvements required for success in the phase 3 Combination of OPT-302 with Aflibercept Study (COAST) trial.
According to a March 31, 2025, press release from Opthea, the company and have decided to terminate both the COAST and Study of OPT-302 in combination with Ranibizumab (ShORe) trials, as well as ceasing development of sozinibercept in wet AMD.1
In July of 2021, Opthea was granted Fast Track Designation by the US Food and Drug Administration, who highlighted sozinibercept’s potential to address unmet need in AMD treatment. Opthea quickly enacted the initial COAST Phase 3 trial; however, on March 24, 2025, the company announced that COAST had failed to achieve its primary endpoint for mean change in best-corrected visual acuity (BCVA) against aflibercept monotherapy.2
After the failure of the COAST trial, Opthea decided to accelerate the topline data readout of the ShORe trial. The trial aimed to evaluate the efficacy of administering 2 mg sozinibercept intravenously at 4 week (Q4W) or 8 week (Q8W) intervals, combined with 0.5 mg ranibizumab Q4W. This would be contrasted against 0.5 mg ranibizumab monotherapy. However, the trial failed to meet its primary endpoint of mean change in best corrected visual acuity (BCVA) by week 52.1
Patients with wet AMD who received combination therapy Q4W (n = 301) or Q8W (n = 301) exhibited mean change of 13.3 and 12.9 letters from baseline to week 52 respectively (P = .35). Ranibizumab monotherapy recipients (n = 299) exhibited a mean change of 14.2 letters (P = .19). Among the overall population, combination therapy recipients at Q4W (n = 328) and Q8W (n = 326) achieved a mean change of 13.3 and 12.6 letters from baseline respectively (P = .032). Ranibizumab monotherapy recipients (n = 331) exhibited a 14.3 letter change (P = .09).1
Additionally, with the closure of the COAST and ShORe trials, Opthea has expressed concern for its future. The company is estimated to have unaudited cash and cash equivalents of US$100M as of the end of March. Discussions with the DFA Investors are ongoing1
“We are disappointed that COAST and ShORe did not demonstrate the improvements in vision with sozinibercept combination therapy compared to standard of care that we had hoped for,” said Frederic Guerard, PharmD, CEO of Opthea. “We are grateful to all patients, clinical investigators and their staff around the world who participated in the sozinibercept Phase 3 clinical program, and for their contributions in investigating new treatments for wet AMD.”1
References
Opthea announces decision to discontinue wet AMD trials. Opthea Limited. Published online March 31, 2025. Accessed April 2, 2025. https://ir.opthea.com/news-releases/news-release-details/opthea-announces-decision-discontinue-wet-amd-trials-0
Opthea announces Coast Phase 3 trial Topline Results. Opthea Limited. March 24, 2025. Accessed April 02, 2025. https://ir.opthea.com/news-releases/news-release-details/opthea-announces-coast-phase-3-trial-topline-results
