Ocular Therapeutix's Axpaxli Demonstrates Superiority Over Regeneron's Eylea in Phase 3 Trial for Wet AMD
Ocular Therapeutix announced that its experimental drug Axpaxli outperformed Regeneron's blockbuster Eylea in a Phase 3 trial for wet age-related macular degeneration (AMD), with 74.1% of Axpaxli patients maintaining vision at week 36 compared to 55.8% in the Eylea group12
At week 52, 65.9% of Axpaxli patients maintained vision versus 44.2% of Eylea patients, demonstrating the drug's durability12
Axpaxli is a bioresorbable hydrogel incorporating axitinib, a tyrosine kinase inhibitor, designed to reduce treatment frequency with a target dosing interval of six months or longer, compared to Eylea's current four-week initial dosing followed by eight-week maintenance1
The Phase 3 SOL-1 study enrolled 344 treatment-naïve wet AMD patients who first received an eight-week loading period with Eylea before being randomized to receive either Axpaxli or Eylea14
Axpaxli achieved superior anatomic outcomes, with 55.9% of patients maintaining central subfield thickness within 30 micrometers of baseline at week 36 compared to 37.8% for Eylea5
Ocular Therapeutix plans to meet with the FDA to discuss regulatory pathways and file for approval on an accelerated pathway14
Despite the clinical success, Ocular's stock fell 23% in early trading after the announcement, as the performance difference was narrower than some investors had anticipated and investors were concerned about competing against already-approved drugs3
A second Phase 3 trial, SOL-R, enrolling 631 patients is ongoing and is expected to produce topline data in the first quarter of 20274
If approved, Axpaxli would be the first tyrosine kinase inhibitor approved for wet AMD4
Sources:
1. https://medcitynews.com/2026/02/ocular-therapeutix-wet-age-related-macular-degeneration-amd-axpaxli-tki-ocul/
2. https://www.statnews.com/2026/02/17/ocular-therapeutix-axpaxli-wet-amd-treatment-compared-to-eylea-regeneron/
3. https://www.biopharmadive.com/news/ocular-therapeutix-succeeded-phase-3-eye-drug-data-axpaxli-eylea/812329/
4. https://www.biospace.com/drug-development/oculars-hydrogel-beats-regenerons-eylea-in-wet-amd-study-plots-path-to-fda
5. https://retinalphysician.com/issues/2026/january/axpaxli-superior-to-aflibercept-in-wet-amd-trial/