Opthea has announced it has discontinued its COAST and ShORe trials, for neovascular age-related macular degeneration (nAMD), after the failure of both studies.1
In March, Opthea announced the COAST (Combination OPT-302 with Aflibercept Study) global Phase 3 clinical trial failed to meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 in patients with nAMD.
As a result, Opthea accelerated its topline results from the ShORe (Study of OPT-302 in combination with Ranibizumab) trial, announcing it too had failed to meet its primary endpoints.
“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 Opthea CEO Frederic Guerard.
The company and its Development Funding Agreement (DFA) investors agreed to discontinue the development of sozinibercept in nAMD with immediate effect.
An Opthea news release said there “remains material uncertainty as to Opthea’s ability to continue as a going concern”. Negotiations with DFA investors were continuing.
… there “remains material uncertainty as to Opthea’s ability to continue as a going concern”
Reference
- Opthea, Opthea announces decision to discontinue wet AMD trials (media release, 31 March 2025) available at: ir.opthea.com/news-releases/news-release-details/opthea-announces-decision-discontinue-wet-amd-trials-0 [accessed April 2025]
