Ocular Therapeutix's Eye Drug Outperforms Regeneron's Eylea in Final Trial

• 74% of patients receiving Axpaxli maintained vision at 36 weeks versus 56% with Eylea; after one year, nearly 66% of Axpaxli patients maintained vision compared to less than half on Eylea
• The trial enrolled 344 newly diagnosed wet AMD patients and demonstrated better fluid control in the eye, with many Axpaxli patients not requiring additional rescue injections for almost a year
• Ocular Therapeutix plans to discuss the data with the FDA and submit a marketing application based on these results

Summary: Ocular Therapeutix's Eye Drug Outperforms Regeneron's Eylea in Final Trial

Key Development:

Ocular Therapeutix announced Tuesday that its experimental eye drug Axpaxli demonstrated superior efficacy compared to Regeneron's approved treatment Eylea in a late-stage trial for wet age-related macular degeneration (AMD). This marks the first time an investigational drug has outperformed an approved treatment in a trial meeting strict FDA standards for this indication.

Trial Results:

The study enrolled 344 patients with newly diagnosed wet AMD. At 36 weeks, 74% of patients receiving a single 0.45 mg dose of Axpaxli maintained vision compared to 56% on a single 2 mg dose of Eylea. At one year, nearly 66% of Axpaxli patients maintained vision versus less than 50% in the comparison group. The drug also showed improved fluid control in the eye, a critical disease management metric.

Clinical Significance:

Many Axpaxli patients did not require additional "rescue" injections for nearly a year, potentially reducing clinic visit frequency. CEO Pravin Dugel called the results "one of the most consequential advances in retina" in recent years.

Market Context:

Wet AMD affects approximately 1.7 million Americans and is a leading cause of blindness in the elderly, causing vision loss through abnormal retinal blood vessel growth. Eylea is currently one of the most widely used treatments for this condition.

Next Steps:

The Massachusetts-based company plans to discuss the data with the FDA and expects to submit a marketing application based on these results.

Market Implications:

This development poses a significant competitive threat to Regeneron's Eylea franchise and could reshape the wet AMD treatment landscape if approved.