Ocular Therapeutix Announces Accelerated Timelines for SOL-1 Registrational Trial of Axpaxli in Wet AMD
Ocular Therapeutix announced an acceleration of the SOL-1 phase 3 registrational clinical trial of Axpaxli for wet age-related macular degeneration (wet AMD). The company now expects to complete enrollment and randomization by the end of 2024, ahead of previous guidance to finish by the first quarter of 2025. As a result, topline data from the trial are anticipated in the fourth quarter of 2025.
Axpaxli (axitinib intravitreal implant, also known as OTX-TKI) is an investigational, bioresorbable hydrogel implant delivering axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties. It is currently being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases
The SOL-1 study is a superiority trial conducted under a Special Protocol Agreement (SPA) with the FDA. It aims to compare the efficacy of Axpaxli to aflibercept, a current standard-of-care treatment for wet AMD. The trial will enroll approximately 300 subjects, who will receive two loading doses of aflibercept (2 mg) at Weeks -8 and -4, followed by randomization (1:1) to either a single Axpaxli implant (450 µg) or a single aflibercept (2 mg) injection on Day 1. The study’s primary endpoint is the proportion of subjects maintaining visual acuity, defined as a loss of fewer than 15 ETDRS letters of best corrected visual acuity (BCVA) at Week 36.
If successfully completed, the SOL-1 trial, alongside the SOL-R repeat-dosing noninferiority study, could serve as the foundation for Ocular’s regulatory filing for Axpaxli in the treatment of wet AMD.
“Thanks to our phenomenal team and their relentless dedication, we are thrilled to announce the acceleration of our timeline for SOL-1,” Pravin U. Dugel, MD, Executive Chairman, President, and CEO of Ocular Therapeutix, said in a company news release. “This rapid recruitment pace reflects strong interest in Axpaxli's potential to reshape wet AMD treatment. We are extremely proud to provide this update, given early concerns that SOL-1 might be challenging to enroll. With 100 clinical sites activated, we are grateful for the continued collaboration of our outstanding study partners. This momentum brings us closer to improving the lives of patients suffering from wet AMD.”
"SOL-1 and SOL-R are thoughtfully designed complementary trials, which have the potential to deliver meaningful insights on durability, repeat dosing, and comparability to standard-of-care treatment, while meeting FDA regulatory requirements," said David A. Eichenbaum, MD, Director of Research at Retina Vitreous Associates of Florida. "With SOL-1 soon to complete randomization, I am excited to now enroll patients in SOL-R. I believe patients in the SOL-R study will take comfort in knowing they are receiving an active treatment, regardless of which arm they are randomized to, while the study design mitigates the risk of unmasking from sham injections."