Ocular Therapeutix Announces First Subjects Screened in Phase 3 Clinical Trial of Axpaxli in Wet AMD

Ocular Therapeutix announced that the first three subjects have been screened and received their first aflibercept injection in the phase 3 SOL-1 clinical trial of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (AMD). The company previously announced FDA agreement on its special protocol assessment (SPA) agreement modification on January 25.

Axpaxli is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.

“The screening of these subjects in the pivotal phase 3 SOL-1 trial of Axpaxli marks an exciting milestone for Ocular Therapeutix,” Antony Mattessich, CEO of Ocular Therapeutix, said in a company news release. “Axpaxli has demonstrated promising durability, biological activity, and a favorable safety profile in earlier studies. We believe that Axpaxli could set a new standard in wet AMD therapy by significantly extending time between treatments. If successful, this first-of-its-kind implant could reduce injection burden for patients and doctors alike while leading to better long-term outcomes.”