Results of the global Phase 3 clinical trial COAST (Combination OPT-302 with Aflibercept Study) in patients with wet AMD were released by Opthea Limited (ASX), a clinical-stage biopharmaceutical company creating innovative treatments to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD).
For the treatment of wet AMD, the worldwide COAST Phase 3 trial assessed the safety and effectiveness of intravitreally delivered 2 mg sozinibercept every 4 or 8 weeks in combination with 2 mg aflibercept, as prescribed, every 8 weeks following a loading phase. The mean change in best corrected visual acuity (BCVA) from baseline to week 52 was the trial’s primary goal, and it was not met.
Participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=296) or every eight weeks (n=297) in wet AMD patients with minimally classic and occult lesions experienced a mean change in BCVA of 13.2 or 13.2 letters from baseline to week 52, respectively, as opposed to 13.8 letters with aflibercept monotherapy (n=299, p-values of 0.59 and 0.62 respectively).
In the general population, the mean change in BCVA from baseline to week 52 was 13.5 and 12.8 letters for participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=333) or every eight weeks (n=330), respectively, compared to 13.7 letters for those receiving aflibercept monotherapy (n=330, p-values of 0.86 and 0.42, respectively).
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The primary and secondary endpoints did not show any numerical differences. The combo treatment of sozinibercept was well tolerated.
Since receiving these findings, Opthea has carefully examined the data to guarantee its integrity and accuracy. Through this approach, no anomalies were found that would lead the Board to take a different stance on the previously mentioned evidence.
Source: Opthea
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