Ocular Therapeutix announces SOL-1 Phase 3 of Axpaxli met primary endpoint

Ocular Therapeutix (OCUL) announced positive topline results from the SOL-1 Phase 3 superiority trial of Axpaxli, its investigational product candidate, for the treatment of wet age-related macular degeneration. After a loading phase, the SOL-1 trial compared a single dose of Axpaxli to a single dose of aflibercept in patients with wet AMD. Under the pre-specified statistical analysis plan, which is aligned with the U.S. FDA in the SOL-1 Special Protocol Assessment agreement, the superiority primary endpoint at Week 36 was met with high statistical significance. In addition to achieving the primary endpoint, Axpaxli showed either statistical significance or numerical superiority to aflibercept in key secondary and prespecified exploratory endpoints.