Opthea’s Wet AMD Drug Fails Phase 3 Endpoints; in Discussion with Creditors

Opthea Ltd. (ASX/NASDAQ: OPT) announced that its COAST Phase 3 trial for wet age-related macular degeneration (wet AMD) failed to meet its primary endpoint, raising concerns over the company's financial stability.

Opthea in discussion with creditors to clarify whether the company will remain solvent following Phase 3 trial missing key endpoints.

The trial tested sozinibercept in combination with aflibercept but showed no significant improvement in best corrected visual acuity (BCVA) compared to aflibercept alone. Patients receiving the combination therapy achieved BCVA improvements of 13.2–13.5 letters versus 13.7 letters for monotherapy, with p-values above 0.4, indicating no statistical significance. Secondary endpoints also showed no meaningful differences.

Following the disappointing results, Opthea is assessing the implications under its Development Funding Agreement (DFA), which could trigger repayment obligations of up to $680 million if certain conditions are met.

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.

The company is in discussions with DFA investors to explore possible solutions or outcomes to the predicament.

With $113.8 million in cash as of Feb. 28, 2025, Opthea's ability to continue as a going concern is uncertain. The company has suspended trading of its shares on ASX and Nasdaq pending further clarity. Opthea had a market capitalisation of about A$738M at 60 cents per share, prior to suspension.