Key Takeaways

• AXPAXLI is a bioresorbable hydrogel incorporating axitinib, targeting wet AMD and other retinal diseases with anti-angiogenic properties.
• The SOL-R trial compares AXPAXLI’s six-month dosing to aflibercept’s eight-week dosing, focusing on BCVA non-inferiority at week 56.
• SOL-1 and SOL-R trials aim to demonstrate AXPAXLI’s durability and support its clinical adoption with predictable dosing.
• Ocular Therapeutix plans an NDA submission to the FDA following positive results from SOL-1 and SOL-R trials.

The SOL-R registrational trial (NCT06495918) of OTX-TKI (AXPAXLI) by Ocular Therapeutix has reached its randomization target of 555 patients.

The company describes AXPAXLI as an “investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties. It is currently being evaluated for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy, diabetic macular edema (DME), and other retinal diseases.”¹

The trial is a phase 3, multi-center, 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 are enrolled across approximately 100 sites across the United States, Argentina, India, and Australia.

In the trial, patients in the first arm receive a single dose of AXPAXLI at day 1 and are re-dosed at weeks 24, 48, and 72. Patients in the second arm receive aflibercept (2 mg) on day 1 and per label every 8 weeks. Patients in the third arm receive a single dose of aflibercept (8 mg) at day 1 and are re-dosed at weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate masking. Patients are followed for safety and will remain masked until the end of year 2.

Read more: Ocular Therapeutix reaches target enrollment of 555 patients in SOL-R trial | Ophthalmology Times – Clinical Insights for Eye Specialists

Source: Ophthalmolgy Times

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