Opthea Phase 3 Fails

The global 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 nAMD.  

In nAMD patients with minimally classic and occult lesions, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=296) or every eight weeks (n=297) achieved a mean 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). In the overall population, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=333) or every eight weeks (n=330) achieved a mean 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). 

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

Opthea confirmed that a review of the data found no anomalies in the process that would cause the adoption of an alternative view on the data outlined above. 

COAST… global Phase 3 clinical trial has failed to meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52

Question Over Solvency 

The failed study places the financial security of Opthea in question as the company could be required to pay up to US$680 million to development fund investors, which would have a material adverse impact on Opthea’s solvency. Opthea  requested trading in its listed securities continue to be suspended on both ASX and Nasdaq until the earlier of Opthea being in a position to provide an announcement to the market by Opthea providing more clarity on these issues or the commencement of trading on Monday, 31 March 2025.