Axpaxli Demonstrates Superiority Over Aflibercept in Wet AMD Phase 3 Trial
Overview
The phase 3 SOL-1 trial showed that Axpaxli, an intravitreal insert containing axitinib, outperformed aflibercept in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Axpaxli demonstrated superior visual acuity maintenance, fluid control, and anatomic outcomes with a favorable safety profile.
Background
Neovascular (wet) age-related macular degeneration is a leading cause of vision loss, typically managed with anti-VEGF agents like aflibercept. Despite their efficacy, current treatments require frequent injections and may not fully control disease progression. Axpaxli is a novel bioresorbable intravitreal hydrogel delivering axitinib, a tyrosine kinase inhibitor with antiangiogenic properties, aiming to improve durability and outcomes in wet AMD therapy.
Data Highlights
| Endpoint | Axpaxli | Aflibercept | Risk Difference | P-value |
|---|---|---|---|---|
| Visual acuity maintenance at Week 36 (% subjects) | 74.1 | 55.8 | 17.5% | 0.0006 |
| Visual acuity maintenance at Week 52 (% subjects) | 65.9 | 44.2 | 21.1% | <0.0001 |
| Rescue-free rates at Week 24 | 80.6% | 72.1% | 8.5% | Not reported |
| Rescue-free rates at Week 36 | 74.7% | 56.4% | 18.3% | Not reported |
| Rescue-free rates at Week 52 | 68.8% | 47.7% | 21.1% | Not reported |
| CST control within 30 μm at Week 36 | 55.9% | 37.8% | 17.1% | 0.0013 |
| CST control within 30 μm at Week 52 | 44.1% | 34.9% | 9.2% | 0.1094 |
Key Findings
- Axpaxli achieved statistically significant superiority over aflibercept in maintaining visual acuity at weeks 36 and 52.
- Higher rescue-free rates were observed with Axpaxli at weeks 24, 36, and 52, indicating more durable disease control.
- Axpaxli demonstrated superior anatomic control of central subfield thickness at week 36, with sustained numerical advantage at week 52.
- The safety profile of Axpaxli was favorable, with no treatment-related serious ocular adverse events reported.
- Axpaxli is the first investigational wet AMD therapy with a novel mechanism to demonstrate superiority to an approved anti-VEGF agent in over 20 years.
- The SOL-1 trial was conducted under an FDA special protocol assessment, supporting an accelerated new drug application pathway.
Clinical Implications
Axpaxli offers a promising new treatment option for wet AMD with improved visual and anatomic outcomes compared to standard aflibercept therapy. Its sustained efficacy and favorable safety profile may reduce treatment burden and improve patient adherence. Clinicians should anticipate potential integration of Axpaxli into practice pending regulatory approval.
Conclusion
The SOL-1 trial establishes Axpaxli as a superior and well-tolerated therapy for treatment-naïve wet AMD patients, representing a significant advancement in exudative retinal disease management. Ongoing studies will further define its long-term safety and efficacy.
References
- Ocular Therapeutix/2024 -- Axpaxli Superior to Aflibercept in Wet AMD Trial
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