Opthea Discontinues Sozinibercept Development For Wet AMD After Phase 3 Failures

(RTTNews) - Opthea Limited (OPT, OPT.AX) announced its decision to discontinue the development of sozinibercept for wet age-related macular degeneration or wet AMD. This follows the negative results from the Phase 3 COAST and ShORe trials.

The company announced updates on its Phase 3 clinical program, including the termination of COAST (Combination of OPT-302 with Aflibercept Study) and results from its second Phase 3 trial ShORe (Study of OPT-302 in combination with Ranibizumab) in patients with wet AMD.

Following the negative results of the COAST Phase 3 trial announced on 24 March 2025, Opthea determined that the most appropriate course of action for wet AMD patients, shareholders, and other stakeholders was to accelerate the ShORe trial topline data readout, including in consultation with its Development Funding Agreement investors.

The company noted that the global ShORe Phase 3 trial evaluated the efficacy and safety of intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 0.5 mg ranibizumab every four weeks, as per label, versus 0.5 mg ranibizumab monotherapy. The trial did not meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52.

"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, Chief Executive Officer of Opthea.

Opthea announced that the company and the DFA Investors agreed to discontinue the development of sozinibercept in wet AMD with immediate effect, and that this decision did not constitute a termination event under the DFA resulting in any amount payable by Opthea.

It remains possible that under the DFA, in certain circumstances upon or following termination of the DFA, Opthea could become required to pay a multiple of the amount funded by the DFA Investors that would have a material adverse impact on the solvency of the Company. Termination can be triggered by a range of events, including, among other things, Opthea's insolvency, in which case Opthea will be obligated to pay a multiple of the amounts funded by the DFA Investors.

Opthea said it continues active discussions with the DFA Investors to explore possible options to deliver the best outcome for the Company and its shareholders.

Opthea estimates it will have unaudited cash and cash equivalents of US$100 million at the end of March 2025.