Opthea Limited completed the final week 52 patient visit in COAST, a phase 3 pivotal trial investigating the superiority and safety of sozinibercept in combination with aflibercept 2 mg (Eylea; Regeneron), compared to standard of care alone for the treatment of wet AMD, the company reported in a press release.

COAST is 1 of 2 concurrent global pivotal phase 3 clinical trials investigating sozinibercept combination therapy vs standard of care alone; the other study, ShORe, is investigating treatment with sozinibercept in combination with ranibizumab 0.5 mg (Lucentis; Genentech). The primary endpoint for both trials is the mean change in best-corrected visual acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy, the company said. Topline results from COAST are expected in the second quarter of 2025, while results from ShORe are anticipated in mid-2025, the company said. Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability.

According to the company, Opthea’s phase 3 program is designed to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients. Sozinibercept has received Fast Track Designation from the US Food and Drug Administration for the treatment of wet AMD. RP