Ocular Therapeutix Nears SOL-R Trial Completion for Wet AMD

Ocular Therapeutix has announced that enrollment will close this week for its SOL-R registrational trial evaluating Axpaxli (OTX-TKI) in patients with wet age-related macular degeneration (AMD). The SOL-R trial is considered the largest retinal tyrosine kinase inhibitor (TKI) study to date.

Enrollment Progress and Trial Development Overview

Dr. Pravin U. Dugel, MD, Executive Chairman, President, and CEO of Ocular Therapeutix, stated in a company news release:

“Completing enrollment in SOL-R—the largest retinal TKI trial to date—one year after the study was conceptualized reflects an extraordinary pace of execution and underscores our commitment to advancing innovation for patients with wet AMD.”

He added that SOL-R and SOL-1, two FDA-aligned registrational trials, aim to form the foundation for a potential Axpaxli label that includes a distinct superiority claim and extended 6- to 12-month dosing. Dugel emphasized the company’s focus on disciplined trial execution, highlighting the high patient retention and protocol adherence observed in both trials. He expressed gratitude to patients, investigators, and study sites for their collaboration.

Target Randomization Achieved Across Global Sites

Based on screening, loading, and randomization data, Ocular Therapeutix reports that enrollment has met the necessary threshold to support target randomization of at least 555 subjects. Trial participants were enrolled across approximately 100 sites in the United States, Argentina, India, and Australia.

About the SOL-R Trial: Design and Endpoints

SOL-R is Ocular’s second registrational study for Axpaxli in wet AMD and is being conducted in parallel with SOL-1. The SOL-R trial evaluates the safety and efficacy of Axpaxli dosed every 6 months, compared to aflibercept (2 mg) administered every 8 weeks.

Following initial screening and enrollment, participants undergo standard anti-VEGF treatment during a loading phase, after which eligible individuals are randomized into the trial. The primary endpoint is to demonstrate noninferiority in the mean change in best corrected visual acuity (BCVA) from baseline at Week 56. The study is 90% powered to detect a noninferiority margin of -4.5 letters in mean BCVA relative to aflibercept.

Regulatory Alignment and Future Outlook

Ocular Therapeutix reports that the FDA has confirmed both SOL-1 and SOL-R may serve as adequate and well-controlled trials to support a New Drug Application (NDA) for Axpaxli in wet AMD. The trial designs were developed in alignment with FDA guidance, with SOL-1 having undergone a Special Protocol Assessment (SPA), and written confirmation for SOL-R received in 2024.

Pending positive outcomes from both trials, Ocular plans to submit an NDA to the FDA following the 56-week data readout from SOL-R.

About Axpaxli (OTX-TKI)

Axpaxli, also known as OTX-TKI, is an investigational, bioresorbable intravitreal hydrogel incorporating axitinib, a small molecule, multi-target tyrosine kinase inhibitor (TKI) with anti-angiogenic properties. It is being studied for the treatment of multiple retinal diseases, including:

       • Wet Age-Related Macular Degeneration (AMD)

       • Diabetic Retinopathy

       • Diabetic Macular Edema (DME)

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