Objective:
To evaluate the efficacy and safety of Axpaxli compared to aflibercept in treatment-naïve patients with neovascular age-related macular degeneration (nAMD).
Key Findings:
- 74.1% of Axpaxli-treated subjects maintained visual acuity at week 36 vs 55.8% for aflibercept (P=.0006).
- 65.9% maintained vision at week 52 on Axpaxli vs 44.2% on aflibercept (P<.0001).
- Axpaxli showed superior anatomic outcomes with 55.9% maintaining CST within 30 μm of baseline at week 36 vs 37.8% for aflibercept (P=.0013).
- Safety profile was consistent with previous studies, with no serious ocular adverse events reported.
Interpretation:
Axpaxli demonstrates significant improvements in both visual acuity and anatomic control compared to the standard treatment, suggesting it could alter treatment paradigms for wet AMD.
Limitations:
- The trial results are based on a single phase 3 study.
- Long-term safety and efficacy data are still pending as the trial continues through week 104.
Conclusion:
Axpaxli has the potential to be a transformative treatment for wet AMD, with plans for regulatory submission to the FDA on an accelerated pathway.
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