Opthia could owe $1bn to investors following sozinibercept trial failure

Australian biotech Opthea faces potential liabilities exceeding $1 billion after its Phase III COAST trial failed to show that its wet AMD therapy, sozinibercept (OPT-302), improved vision compared to standard aflibercept treatment.

The study, conducted across 209 international sites, found that patients receiving the OPT-302 and aflibercept combination gained 13.2–13.5 letters in best corrected visual acuity (BCVA) after 52 weeks—comparable to the 13.7–13.8 letters achieved with aflibercept alone. Given these results, Opthea may need to repay DFA investors up to $680 million, a potential solvency risk.

Despite this setback, the wet AMD market remains competitive, with Regeneron’s Eylea HD showing promise in Phase III trials, and Ocugen advancing its OCU200 therapy. GlobalData projected sozinibercept could have generated $575 million annually by 2030 had it succeeded.

24-03-2025

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