Ocular Therapeutix Achieves Randomization Target in SOL-R Trial

Ocular Therapeutix announced that its SOL-R registrational trial of Axpaxli (OTX-TKI) in wet age-related macular degeneration (AMD) has achieved its randomization target of 555 patients.

SOL-R is the company’s second registrational trial of Axpaxli in wet AMD. Ocular Therapeutix will continue to allow randomization of previously enrolled patients currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027.

“Reaching target randomization in SOL-R marks another significant milestone for Ocular and reflects the remarkable speed and execution of our clinical team, along with the overwhelming enthusiasm and engagement from investigators across the world. The exceptional pace and scale of recruitment across our SOL program underscore the strong demand among retina specialists and patients for more durable therapies like Axpaxli that can potentially deliver better long-term outcomes while reducing the treatment burden,” said Pravin U. Dugel, MD, executive chairman, president, and CEO of Ocular Therapeutix.

Dr. Dugel added, “SOL-1 and SOL-R were intentionally developed to complement each other: SOL-1 is designed to demonstrate Axpaxli’s true durability up to 12 months and enable what could become the first superiority label versus a single dose of anti-VEGF therapy, while SOL-R is designed to provide data supporting the immediate adoption of Axpaxli into clinical practice with predictable every-6-month dosing. Across both trials, we have thoughtfully de-risked our approach to optimize patient selection and ensure rigor in execution. SOL-R is the first trial of its kind to include an extensive 6-month screening and loading phase specifically designed to exclude subjects with early persistent fluid or significant retinal fluid fluctuations which can otherwise introduce variability and disrupt noninferiority trials. This deliberate approach should result in the randomization of a more uniform patient population, thereby de-risking the study and strengthening the reliability of its data. We deeply appreciate the trust and collaboration of the patients, investigators, and study sites who are helping us advance toward what we believe could become a new standard-of-care in retinal disease.”

SOL-R is a phase 3, multicenter, double-masked, randomized (2:2:1) trial evaluating Axpaxli dosed every 6 months versus aflibercept (2 mg) dosed every 8 weeks in treatment-naïve wet AMD patients. Patients for SOL-R are enrolled across approximately 100 sites in the United States, Argentina, India, and Australia. The primary endpoint is to demonstrate noninferiority in mean change in best corrected visual acuity from baseline at week 56. SOL-R is 90% powered to detect a noninferiority margin of -4.5 letters. A singular week 56 primary endpoint in SOL-R is potentially favorable as subjects will have received their most recent aflibercept or Axpaxli injection 8 weeks prior, at week 48.

“The complementary SOL-1 and SOL-R trials are thoughtfully designed to jointly address the key questions that matter most to clinicians and patients,” said Mark R. Barakat, MD, director of research at Retina Macula Institute of Arizona and clinical assistant professor at the University of Arizona College of Medicine in Phoenix. “Retina specialists are looking for a therapy that truly delivers long-term durability without compromising outcomes. Patients desire that same durability to reduce the burden of frequent injections. Even with our most advanced options today, vision usually declines over time. If both studies succeed, Axpaxli will have shown greater durability than aflibercept (2 mg) and sustained benefit at a predictable, low frequency of dosing, providing the confidence we need to treat patients with potentially better outcomes. The rapid pace of enrollment across the SOL program underscores the strong enthusiasm for Axpaxli’s potential to transform long-term management of wet AMD and other retinal diseases.”

SOL-1, the first registrational trial in wet AMD from Ocular Therapeutix, is a superiority study evaluating a single injection of Axpaxli versus a single aflibercept (2 mg) injection with topline data expected in the first quarter of 2026. SOL-1 and SOL-R are complementary trials designed in alignment with FDA guidance and validated through a Special Protocol Assessment agreement for SOL-1 and written responses for SOL-R received in 2024. Pending positive results from SOL-1 and SOL-R, Ocular Therapeutix plans to submit a New Drug Application for FDA review following 56-week topline data from SOL-R. The FDA has agreed that, together, SOL-1 and SOL-R could constitute two adequate and well-controlled trials to support a potential New Drug Application and label for Axpaxli in wet AMD.