Opthea Part 3 Trial Fails To Meet Main Endpoint, Faces Monetary Uncertainty – Opthea (NASDAQ:OPT)

On Monday, Opthea Restricted OPT launched outcomes from its international Part 3 medical trial COAST in sufferers with moist age-related macular degeneration (moist AMD).

The trial evaluated the efficacy and security of intravitreally administered 2 mg sozinibercept each 4 or eight weeks together with 2 mg Regeneron Prescribed drugs Inc’s REGN Eylea (aflibercept), as per label, each eight weeks after a loading part for moist AMD.

The trial didn’t meet its major endpoint of imply change in finest corrected visible acuity (BCVA) from baseline to week 52.

In moist AMD sufferers with minimally basic and occult lesions, contributors receiving sozinibercept mixture remedy with a dosing routine of each 4 weeks (n=296) or each eight weeks (n=297) achieved a imply change in BCVA of 13.2 or 13.2 letters from baseline to week 52, respectively, versus 13.8 letters with aflibercept monotherapy (n=299, p-values of 0.59 and 0.62 respectively).

Within the total inhabitants, contributors receiving sozinibercept mixture remedy with a dosing routine of each 4 weeks (n=333) or each eight weeks (n=330) achieved a imply change in BCVA of 13.5 and 12.8 letters from baseline to week 52, respectively, versus 13.7 letters with aflibercept monotherapy (n=330, p-values of 0.86 and 0.42 respectively).

No numerical distinction was noticed in the important thing secondary endpoints. Sozinibercept mixture remedy was effectively tolerated.

After the destructive outcomes from the COAST trial, Opthea is reviewing its obligations underneath its Improvement Funding Settlement (DFA) with buyers.

Primarily based on the phrases of the DFA, the corporate could also be required to make funds that might considerably influence its monetary stability. Opthea may owe buyers between $0 and $680 million if the settlement is terminated, relying on the circumstances.

Opthea’s management is actively discussing with DFA buyers to discover potential options.

The DFA buyers additionally maintain a lien on all of Opthea’s belongings, which means the corporate can’t tackle extra debt or promote key belongings with out their approval.

No selections have been made concerning the COAST trial or whether or not to speed up and unmask the ShORe trial. Discussions with DFA buyers are ongoing to find out one of the best path ahead.

As of February 28, 2025, Opthea had $113.8 million in money and equivalents. Nevertheless, there’s vital uncertainty concerning the firm’s means to proceed working.

Opthea has requested that buying and selling be suspended on each ASX and Nasdaq till Opthea is able to present an announcement to the market by Opthea offering extra readability on these points or the graduation of buying and selling on March 31, 2025.

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