Ocular Therapeutix, Inc. (NASDAQ: OCUL) has announced the completion of target randomization in its SOL-1 Phase 3 clinical trial for AXPAXLI™ (axitinib intravitreal implant), also known as OTX-TKI, in patients with wet age-related macular degeneration (wet AMD). The company expects to close randomization this week and anticipates topline data in Q4 2025.
The SOL-1 trial is a multi-center, double-masked, randomized (1:1), parallel group study involving over 100 clinical trial sites in the U.S. and Argentina. It aims to evaluate the safety and efficacy of AXPAXLI in approximately 300 treatment-naïve subjects with wet AMD. The primary endpoint is the proportion of subjects who maintain visual acuity, defined as a loss of fewer than 15 ETDRS letters of BCVA at Week 36. The study is being conducted under a Special Protocol Agreement (SPA) with the FDA.
Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix, stated, "SOL-1 reaching target randomization in 2024 is a landmark event for Ocular... Today’s milestone brings us one step closer to our goal of delivering the first wet AMD therapy potentially capable of being dosed as infrequently as every six to nine months."
SOL-R Enrollment Accelerated
Ocular Therapeutix has also announced that, due to the momentum of the SOL-1 trial, active clinical sites are now enrolling patients directly into the second registrational study, SOL-R. This repeat-dosing trial is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm study involving sites in the U.S. and worldwide. The trial aims to randomize approximately 825 subjects who are treatment-naïve or were diagnosed with wet AMD within three months prior to enrollment.
The SOL-R trial employs a patient enrichment strategy that includes multiple loading doses of aflibercept (2 mg) and monitoring to exclude subjects with significant retinal fluid fluctuations. The primary endpoint of SOL-R is non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at one year. The FDA has agreed that the SOL-R study, a non-inferiority study, could support a potential New Drug Application (NDA).
About AXPAXLI
AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) is an investigational, bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. It is being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases.
Wet AMD: An Unmet Need
Wet AMD is a leading cause of severe, irreversible vision loss, affecting approximately 14 million individuals globally and 1.65 million in the United States alone. Current therapies involve frequent intraocular injections, which can lead to treatment-related adverse events and patient discontinuation. AXPAXLI aims to address the unmet need for more durable therapies that can maintain visual acuity and improve long-term outcomes with less frequent dosing.
