What's Happening?
Ocular Therapeutix has announced positive topline results from its SOL-1 Phase 3 superiority trial for AXPAXLI, an investigational treatment for wet age-related macular degeneration (AMD). The trial demonstrated that AXPAXLI met its primary endpoint, showing superiority over the approved anti-VEGF treatment aflibercept. At Week 36, 74.1% of subjects in the AXPAXLI arm maintained vision, compared to 55.8% in the aflibercept arm. The trial also showed that AXPAXLI was generally well-tolerated, with no treatment-related serious adverse events. Ocular plans to submit a New Drug Application based on these results, pending discussions with the U.S. FDA.
Why It's Important?
The successful results from the SOL-1 trial represent a significant advancement in the treatment
of wet AMD, a leading cause of vision loss. AXPAXLI's ability to maintain vision with fewer treatments could reduce the burden on patients and healthcare systems, offering a more convenient and potentially more effective treatment option. This development could position Ocular Therapeutix as a leader in the retinal disease market, potentially leading to increased market share and revenue. The trial's success also underscores the potential of AXPAXLI to become a new standard of care in wet AMD treatment, pending regulatory approval.
What's Next?
Ocular Therapeutix plans to present detailed results from the SOL-1 trial at the upcoming Macula Society Annual Meeting. The company will also continue with its SOL-R Phase 3 non-inferiority trial, with topline data expected in the first quarter of 2027. If the New Drug Application is approved, AXPAXLI could become the first tyrosine kinase inhibitor to be commercialized for wet AMD, potentially transforming treatment protocols. The company will likely engage in further discussions with the FDA to finalize the regulatory pathway and prepare for potential market entry.
