Ocular Therapeutix Enrolls First Patient in Three-Year SOL-X Extension Trial for AXPAXLI
Ocular Therapeutix enrolled its first patient in the SOL-X long-term extension trial for AXPAXLI in wet AMD in April 2026, opening a three-year follow-up for subjects who completed two-year SOL-1 or SOL-R trials. SOL-X will assess AXPAXLI’s safety, long-term visual outcomes, fibrosis and atrophy incidence under continuous VEGF suppression.
1. SOL-X Trial Launch
Ocular Therapeutix enrolled its first subject in April 2026 into the SOL-X long-term extension trial for AXPAXLI in wet AMD, providing an additional three years of follow-up for participants who successfully completed their two-year SOL-1 or SOL-R studies.
2. Trial Design and Objectives
SOL-X is a 36-month open-label extension where patients receive AXPAXLI intravitreal injections every 24 weeks at Day 1 post-Week 104 in SOL-1 or post-Week 96 in SOL-R, with safety, visual acuity, fibrosis and macular atrophy assessments at Weeks 4, 12 and every 12 weeks thereafter, and optional supplemental anti-VEGF injections as needed.
3. AXPAXLI Mechanism and Rationale
AXPAXLI combines a bioresorbable intravitreal hydrogel with axitinib to deliver continuous VEGF suppression; Phase 3 SOL-1 data demonstrated unmatched durability and sustained disease control, supporting investigation of long-term outcomes and potential reduction in fibrosis and atrophy.
4. Potential Clinical and Market Impact
SOL-X outcomes could validate earlier initiation strategies, reduce injection burden, limit long-term tissue damage, boost patient retention and expand AXPAXLI’s addressable wet AMD market by demonstrating transformative benefits over current pulsatile therapies.