Ocular Therapeutix To Close Enrollment this Week for SOL-R Trial Evaluating Axpaxli in Wet AMD

Ocular Therapeutix announced that enrollment in the SOL-R registrational trial of its product candidate Axpaxli in wet age-related macular degeneration (AMD) will close this week.

“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,” Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer, said in a company news release. “Together with SOL-1, these two complementary, FDA-aligned registrational trials have the potential to form a robust clinical foundation to support an Axpaxli label with a distinct superiority claim and unprecedented 6- to 12-month dosing. With recruitment ending, we are focused on disciplined trial execution, and we are encouraged by the remarkable retention and adherence to protocol we’ve observed to date in both SOL-1 and SOL-R. We’re immensely grateful to the patients, investigators, and study sites whose partnership brings us one step closer to introducing a potential new standard of care in retinal disease.”

Based on current and projected screening, loading, and randomization failure rates observed in SOL-R to date, Ocular said it believes it has enrolled enough subjects to ensure the company’s target randomization of at least 555 subjects in SOL-R. Subjects for SOL-R are enrolled across approximately 100 sites in the US, Argentina, India, and Australia.

SOL-R is Ocular’s second registrational study for AXPAXLI in wet AMD. The trial is evaluating the safety and efficacy of AXPAXLI dosed every 6 months versus aflibercept (2 mg) every 8 weeks. Subjects who have been screened and enrolled will now be treated with standard of care anti-VEGF treatment and evaluated during a loading phase with the goal of randomizing at least 555 subjects. The primary endpoint of SOL-R is to demonstrate noninferiority in mean change in best corrected visual acuity (BCVA) from baseline between the Axpaxli and on-label aflibercept (2 mg) arms at Week 56. The trial is 90% powered to detect a noninferiority margin of -4.5 letters of mean BCVA when compared to aflibercept (2 mg) dosed every 8 weeks.

According to Ocular, 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 (NDA) and label for Axpaxli in wet AMD. These complementary trials were designed in alignment with FDA guidance and validated through a Special Protocol Assessment (SPA) agreement for SOL-1, and written responses for SOL-R received in 2024. Pending positive results from SOL-1 and SOL-R, Ocular plans to submit an NDA for FDA review following 56-week data from SOL-R.

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, being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic macular edema (DME), and other retinal diseases.