Enrollment Begins for Ocular Therapeutix’s Axpaxli Phase 3 SOL-R Wet AMD Study

Ocular Therapeutix announced that the first patients have been enrolled in the phase 3 SOL-R clinical trial evaluating repeat dosing of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD).

According to the company, SOL-R is a global noninferiority study designed to evaluate the safety and efficacy of Axpaxli. It is a multicenter, double-masked, randomized (2:2:1), three-arm study that will be conducted at sites in the United State and the rest of the world. The trial is evaluating Axpaxli versus the current standard of care under the “real world” requirements of a repeat-dosing regimen.

Ocular Therapeutix stated that the trial is intended to randomize approximately 825 patients who are treatment naïve or diagnosed with wet AMD in the study eye within 3 months before enrollment. Repeat dosing of Axpaxli every 6 months (Q6M) will be compared to 2-mg aflibercept, dosed every 8 weeks (Q8W) in patients with wet AMD. The company noted that the third arm evaluating 8-mg aflibercept dosed Q6M is incorporated to ensure the study is adequately masked.

The primary endpoint is noninferiority in mean best corrected visual acuity change from baseline between the Axpaxli and on-label aflibercept (2 mg) arms at 1 year.

Axpaxli is an investigational bioresorbable, hydrogel implant incorporating axitinib, which is a small molecule, multitarget, tyrosine kinase inhibitor with anti-angiogenic properties. Axpaxli is being evaluated for the treatment of wet AMD, diabetic retinopathy, and other retinal diseases, advised Ocular Therapeutix.

Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix discussed the Axpaxli clinical program in the company’s press release.

“Our first phase 3 trial, SOL-1, is intended to show that Axpaxli can safely and durably maintain visual acuity in patients with wet AMD,” commented Dr. Dugel. “SOL-R is intended to build on that by providing physicians with important evidence regarding the potential to redose Axpaxli every 6 months, which better aligns with a likely ‘real world’ experience.”

Dr. Dugel continued, “SOL-R will initially enroll patients who do not qualify to be randomized in SOL-1. Subsequently, SOL-R will be opened to direct enrollment of patients who are treatment naïve or diagnosed with wet AMD within 3 months prior to enrollment. Patients enrolled in SOL-R are similar to those enrolled in our successful United States phase 1 study, with further enrichment through multiple aflibercept loading doses. Further, these patients are evaluated to limit retinal fluid fluctuations between visits prior to randomization, increasing our confidence in the study’s potential success.”

Also commenting in the press release, Arshad M. Khanani, MD, Director of Clinic Research at Sierra Eye Associates in Reno, Nevada, stated, “There is increasing evidence that pulsatile VEGF suppression may result in OCT fluctuations that could lead to poor long-term visual outcomes. Even with new therapeutics entering the wet AMD market, the need for a durable and sustained treatment is substantial for many of my patients. The SOL-R study is critically important because results from this large, repeat-dosing study may provide the retina community with insight on how Axpaxli may be used in our practices.”

Dr. Khanani continued, “Providing patients who do not qualify for SOL-1 randomization with an opportunity to enroll in the SOL-R study is a tremendous service to physicians and the patients they serve. Moreover, I appreciate that SOL-R is designed for Axpaxli re-treatment at 6 months, which is in line with how often I’d ideally like to see my wet AMD patients. That said, it is not uncommon to reschedule appointments, leaving more time in between visits. Fortunately, SOL-1 is designed to generate valuable evidence to determine the ultimate durability of a single Axpaxli implant. Together, these trials aim to provide a comprehensive picture of the flexibility of dosing intervals to meet individual patient needs.”