- Ocular Therapeutix (OCUL, Financial) will close enrollment for its SOL-R trial evaluating AXPAXLI™ in wet AMD this week.
- The trial aims to enroll 555 subjects across 100 international sites for AXPAXLI dosing every 6 months vs. aflibercept every 8 weeks.
- The primary endpoint is non-inferiority in mean change in best-corrected visual acuity at Week 56, supporting an NDA submission.
Ocular Therapeutix, Inc. (OCUL), a leading biopharmaceutical company, has announced it will close enrollment for the SOL-R registrational trial of its promising new treatment AXPAXLI™ for wet age-related macular degeneration (wet AMD) this week. This trial follows the company's first successful registrational trial, SOL-1, which completed enrollment in December 2024 and is on track for its top-line readout in the first quarter of 2026.
The SOL-R study targets the enrollment of at least 555 subjects across approximately 100 sites in the U.S., Argentina, India, and Australia. This trial evaluates AXPAXLI, dosed every 6 months, against the standard aflibercept dosage every 8 weeks. The trial's primary endpoint is to demonstrate non-inferiority in the mean change in best-corrected visual acuity (BCVA) from baseline between AXPAXLI and aflibercept at Week 56, with the trial boasting a robust statistical design, 90% powered to detect a non-inferiority margin of -4.5 letters.
Both the SOL-1 and SOL-R trials align with FDA guidelines and were designed to support a New Drug Application (NDA) submission for AXPAXLI, offering the potential for a superior durability claim and an extended 6- to 12-month dosing schedule. This approach could significantly decrease the treatment burden for patients, who currently require more frequent injections, potentially establishing AXPAXLI as a new standard of care in treating wet AMD.
With the SOL-R trial nearing its conclusion and exceptional retention rates reported, Ocular Therapeutix is poised to advance toward regulatory submission. The focus remains on rigorous trial execution to strengthen the clinical foundation for AXPAXLI, ensuring robust data to support its potential FDA approval.
