February 14, 2024
BEDFORD, Mass. — Ocular Therapeutix, Inc. has 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 (wet AMD). The company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.
“The screening of these subjects in the pivotal Phase 3 SOL-1 trial of AXPAXLI marks an exciting milestone for Ocular Therapeutix,” said Antony Mattessich, CEO of Ocular Therapeutix. “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.”
“Wet AMD patients need options that provide sustained therapy while minimizing their need for frequent injections and office visits,” said Allen Hu, MD, a principal investigator in the SOL study and vitreoretinal surgeon at Cumberland Valley Retina Consultants. “I am thrilled to be participating in research that could shift the existing treatment paradigm for patients with wet AMD.” Dr. Hu is an active principal investigator of innovative technologies for the treatment of macular degeneration, diabetic retinopathy, and retinal vascular disorders, having participated in more than 40 clinical trials during the past 10 years.
