Ocular Therapeutix's Axpaxli Surpasses Regeneron’s Eylea in Phase 3 Trial for Wet AMD
In a major advancement for treating wet age-related macular degeneration (AMD), Ocular Therapeutix reported that their novel drug Axpaxli met the primary endpoint in Phase 3 trials, demonstrating superior vision maintenance compared to Regeneron's established therapy Eylea. This success paves the way for regulatory filing and could shift treatment paradigms for wet AMD patients worldwide.
On February 17, 2026, Ocular Therapeutix announced promising results from the first of two Phase 3 clinical trials for their new wet AMD treatment, Axpaxli. The trial's primary objective was to determine whether Axpaxli could maintain vision in patients suffering from wet age-related macular degeneration—a leading cause of vision loss among older populations.
Clinical Trial Outcomes
In a head-to-head comparison with Eylea, a widely prescribed and successful treatment marketed by Regeneron Pharmaceuticals and Bayer, Axpaxli demonstrated superiority in preserving visual acuity over the study period. These results are significant, suggesting Axpaxli could offer an improved therapeutic option for individuals afflicted by this prevalent retinal disease.
The incremental clinical benefit shown by Axpaxli reflects advanced drug design and potentially a new mechanism of action or more effective delivery technology, aspects that promise better patient outcomes and possibly less frequent dosing.
FDA Filing Prospects and Regulatory Impact
Following these positive results, Ocular Therapeutix is preparing to file for FDA approval. The upcoming submission will be closely scrutinized by regulators who weigh efficacy, safety, and comparative advantages against existing standards of care such as Eylea.
A successful FDA approval would introduce a new competitor in the wet AMD treatment market, which could influence pricing, insurance reimbursement policies, and physician prescribing behavior. It also reinforces the importance of innovation in ophthalmology drug development, addressing unmet clinical needs and enhancing quality of life for patients.
Market and Patient Implications
Wet AMD affects millions globally, presenting a substantial public health challenge with significant medical costs and quality-of-life impacts. The entry of Axpaxli into the market could expand treatment options, especially for patients who respond inadequately to current therapies.
Moreover, Axpaxli’s demonstrated efficacy may stimulate further research and development investment into retinal diseases, accelerating the pipeline of novel treatments in this therapeutic area.
Conclusion
Ocular Therapeutix’s Axpaxli achieving primary endpoint superiority over Regeneron’s Eylea in Phase 3 trials marks a critical milestone in wet AMD therapeutics. The forthcoming FDA filing and eventual market introduction could reshape clinical management of this vision-threatening condition, benefiting patients and healthcare providers alike.
For more comprehensive insights, see: Ocular Therapeutix Eyes FDA Filing After Wet AMD Drug Tops Regeneron’s Eylea in Phase 3 Test
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