Opthea's COAST Phase 3 Trial In Wet AMD Fails To Meet Primary Goal; Assessing Impact Under DFA

(RTTNews) - Opthea Limited (OPT), a clinical-stage biopharmaceutical company focused on retinal diseases, including wet age-related macular degeneration or wet AMD, announced Monday that its global Phase 3 clinical trial COAST (Combination OPT-302 with Aflibercept Study) in patients with wet AMD failed to meet primary endpoint.

The company said it is considering impact of negative trial results under its Development Funding Agreement or DFA and on the company as a going concern.

The COAST Phase 3 trial evaluated the efficacy and safety of intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 2 mg aflibercept, as per label, every eight weeks after a loading phase for the treatment of wet AMD. The company noted that the trial did not meet its primary endpoint of mean change in best corrected visual acuity or BCVA from baseline to week 52.

There was no numerical difference observed in the key secondary endpoints. Sozinibercept combination therapy was well tolerated.

Opthea said it has undertaken a thorough review of the data, following the receipt of these results, to ensure both its accuracy and integrity. No anomalies were identified through the process that would cause the Board to adopt an alternative view on the data.

Following the negative results in the trial, Opthea has been assessing its rights and obligations under its DFA with, among others, the investors under the DFA. In light of these updates, it is possible that under the DFA, Opthea could become required to pay amounts to the DFA Investors that would have a material adverse impact on the solvency of the company.

Opthea's Management and Board of Directors have been in active talks with the DFA Investors to explore possible options for the company in respect of its clinical trial program and to identify whether there is a better pathway.

Opthea and the DFA Investors could reach a negotiated settlement that is different from the parties' existing rights under the DFA.

The company noted that the DFA Investors have security over the assets of Opthea in the form of an "all assets" lien. As a result, Opthea is unable to incur further non-equity funding or dispose of its material assets without the prior consent of the DFA Investors.

Opthea said, "At this stage, no decision has yet been taken with respect to either trial, including whether to discontinue activities for the COAST trial or accelerate and unmask the ShORe trial. Discussions continue with the DFA Investors to determine the most appropriate course of action."

As of February 28, 2025, Opthea has an unaudited cash and cash equivalents balance of $113.8 million.

Amid these issues, there is a material uncertainty as to Opthea's ability to continue as a going concern. Discussions with the DFA Investors are ongoing and Opthea said it cannot be certain as to the outcome of those discussions or when that outcome may become known.

Opthea noted that it has requested that trading in its listed securities continue to be suspended on both ASX and Nasdaq until the earlier of the company being in a position to provide an announcement to the market with more clarity on these issues or the commencement of trading on Monday, March 31.

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