Ocular Therapeutix Reaches SOL-R Trial Milestone

Ocular Therapeutix has achieved its randomization goal of 555 patients in SOL-R, the company’s second registrational Phase 3 trial for Axpaxli (OTX-TKI) in the treatment of wet age-related macular degeneration (AMD). The company will continue randomizing eligible patients already in the loading phase, with topline data expected in the first half of 2027.

SOL-R: Supporting Long-Term Clinical Integration of Axpaxli

SOL-R is designed to generate data supporting the potential adoption of Axpaxli into routine practice with predictable, twice-yearly dosing. The trial is a multicenter, double-masked, randomized (2:2:1) study comparing Axpaxli (administered every 6 months) with aflibercept (2 mg) dosed every 8 weeks in treatment-naïve wet AMD patients. Patients are being enrolled at around 100 sites across the U.S., Argentina, India, and Australia.

The primary endpoint is the mean change in best corrected visual acuity (BCVA) from baseline at week 56, with the trial 90% powered to detect noninferiority with a margin of -4.5 letters.

The study’s design includes a 6-month screening and loading phase, specifically created to exclude patients with persistent or highly variable retinal fluid, which can skew outcomes in noninferiority studies. This deliberate selection process aims to de-risk trial execution and improves data reliability.

About SOL Program

Dr. Pravin U. Dugel, Executive Chairman, President, and CEO of Ocular Therapeutix, highlighted the importance of this milestone:

“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.”

He emphasized the complementary design of SOL-R and SOL-1, Ocular’s first registrational trial:

• SOL-1: A superiority trial comparing a single dose of Axpaxli to a single dose of aflibercept, designed to showcase Axpaxli’s durability up to 12 months.

• SOL-R: Built to support real-world clinical adoption with repeatable 6-month dosing and to provide robust noninferiority data for potential FDA approval.

Both trials are aligned with FDA guidance, SOL-1 under a Special Protocol Assessment (SPA) and SOL-R validated through formal written feedback. Pending favorable data from both trials, the company intends to submit a New Drug Application (NDA), with the FDA agreeing that SOL-1 and SOL-R together could satisfy requirements for approval and labeling of Axpaxli for wet AMD.

Clinical Insights

“Retina specialists are looking for a therapy that truly delivers long-term durability without compromising outcomes,” said Dr. Mark R. Barakat, Director of Research at Retina Macula Institute of Arizona.
“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. “

Dr. Barakat emphasized that the strong pace of enrollment reflects real-world demand for durable treatment options among clinicians and patients alike.

Next Milestones

The topline data from SOL-1 is expected in the first quarter of 2026, followed by SOL-R topline results in the first half of 2027. Contingent upon positive outcomes from both trials, Ocular Therapeutix plans to submit a New Drug Application (NDA) for FDA review after the SOL-R results become available.