Ocular Therapeutix has announced an accelerated timeline for its SOL-1 Phase 3 registrational clinical trial of Axpaxli for wet age-related macular degeneration (AMD). The company now anticipates full enrollment with 300 patients randomized by the end of 2024, and topline data expected in the fourth quarter of 2025.
SOL-1 Trial Details
The SOL-1 trial is a superiority study being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA). The trial design includes an eight-week loading segment where enrolled subjects receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Patients who achieve pre-defined visual acuity measures are then randomized (1:1) on Day 1 to receive either a single Axpaxli implant (450 μg) or a single aflibercept (2 mg) injection. The primary endpoint is the proportion of subjects who maintain visual acuity, defined as <15 ETDRS letters of best corrected visual acuity (BCVA) loss, at Week 36.
SOL-R Trial and Regulatory Strategy
Ocular Therapeutix expects that the ongoing Phase 3 clinical program, which includes both the SOL-1 superiority study and the SOL-R repeat-dosing non-inferiority study, will form the basis of the company’s regulatory filing for Axpaxli for the treatment of wet AMD, if successfully completed.
The SOL-R trial is designed to evaluate the safety and efficacy of Axpaxli in a multi-center, double-masked, randomized (2:2:1), three-arm study. The trial is intended to randomize approximately 825 subjects who are treatment-naïve or were diagnosed with wet AMD in the study eye within three months prior to enrollment. 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.
Management Commentary
Pravin U. Dugel, MD, Executive Chairman, President, and CEO of Ocular Therapeutix, stated, "Thanks to our phenomenal team and their relentless dedication, we are thrilled to announce the acceleration of our timeline for SOL-1, which is now expected to complete randomization by the end of 2024. With this update, we can now confirm that we expect topline data to be available during the fourth quarter of 2025."
David A. Eichenbaum, MD, FASRS, Director of Research, Retina Vitreous Associates of Florida, commented, “Patients with wet AMD need treatment options that offer more durable improvements in visual outcomes. SOL-1 enrollment has advanced at such a rapid pace because Axpaxli is seeking to directly address this critical unmet need, offering the promise of a significantly reduced treatment burden."
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, being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases.
Market Context
Wet AMD affects approximately 14 million individuals globally and 1.65 million in the United States alone. Current treatments involve repeated intraocular injections, which can lead to treatment-related adverse events and patient discontinuation. Axpaxli aims to address the unmet need for more durable and less burdensome treatment options.
