Phase 3 COAST trial of wet AMD combination therapy misses primary endpoint
Key takeaways:
- The primary endpoint was the mean change in best corrected visual acuity at 52 weeks.
- Aflibercept monotherapy demonstrated better BCVA change vs. sozinibercept combination therapy.
Editor’s note: This is a developing news story. Please check back soon for updates.
The phase 3 COAST trial investigating 2 mg sozinibercept for the treatment of wet age-related macular degeneration in combination with 2 mg aflibercept did not meet its primary endpoint, according to a press release from Opthea.
As Healio previously reported, the study enrolled more than 990 patients with wet AMD, with a primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
In patients with minimally classic and occult lesions who received the combination therapy every 4 weeks (n = 296) or every 8 weeks (n = 297), the mean change in BCVA was 13.2 letters from baseline to week 52, while patients treated with aflibercept monotherapy (n = 299) achieved 13.8 letters from baseline. In the overall population, the combination therapy dosed every 4 weeks (n = 333) or every 8 weeks (n = 330) yielded a mean change in BCVA of 13.5 letters and 12.8 letters from baseline to week 52, respectively, compared with 13.7 letters with aflibercept monotherapy (n = 330).
In addition, “there was no numerical difference observed in the key secondary endpoints.”
The release said the combination therapy was well tolerated.
“In light of these updates, it is possible that under the [development funding agreement, or 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,” according to the release. “As previously disclosed, certain instances and events may result upon the termination of the DFA, and upon such termination, Opthea will be obligated to pay the DFA investors up to four multiples of the amounts paid to the company under the DFA.”
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