Ocular Therapeutix's AMD Drug Beats Eylea, But the Stock Plunges: What Was Priced In?

The core clinical results are a clear win on paper. In its pivotal Phase 3 trial, Ocular Therapeutix's drug Axpaxli demonstrated superiority over Regeneron's Eylea, meeting the primary endpoint set by the FDA. The key metric was vision maintenance at 36 weeks: about 74% of patients who received a single dose of Axpaxli maintained their vision, compared to nearly 56% of those receiving Eylea. This translated to a statistically significant 17.5% risk difference favoring Axpaxli.

The durability advantage held through the one-year mark, with 65.9% of Axpaxli patients maintaining vision versus 44.2% in the Eylea group. The drug also showed better control of fluid in the eye and a high rate of patients avoiding additional "rescue" injections for nearly a year. In short, the trial delivered a textbook beat against the benchmark.

Yet this clear clinical victory sparked a debate about commercial potential. The durability difference, while statistically robust, was narrower than investors expected. For a market that had priced in a transformative leap, the incremental benefit may have felt underwhelming. This is the classic expectation gap: the science passed the test, but the magnitude of the win may not have been enough to justify a massive re-rating. The stock's plunge in premarket trading reflects that sentiment-investors are now weighing the clinical triumph against the practical and financial hurdles ahead.

The Market's Disappointment: Why the Stock Fell

The market's reaction was a textbook case of "sell the news." While the trial data itself was a clear clinical win, the stock plunged about 30% in premarket trading on the news. This violent move suggests the positive headline was already priced in, and the actual print failed to meet the whisper number that had driven the share price higher.

The disconnect is stark. Ocular Therapeutix shares had gained nearly 39% in 2025, a rally that likely baked in expectations of a transformative result. The market had priced in a drug that would decisively outperform Eylea, not just beat it. The key metric that disappointed was the magnitude of the durability advantage. The trial showed a 17.5% risk difference favoring Axpaxli, a statistically significant win. But for a stock that had soared on anticipation, that margin was perceived as narrower than expected. As one analyst noted, the difference in treatment durability was narrower than investors expected.

In other words, the trial delivered the required proof of concept, but the size of the victory was the problem. The stock fell because the reality of a 17.5% edge did not justify the premium that had been paid for the rumor of a much larger leap. This is the expectation gap in action: the science passed the test, but the market had already moved on to the next, more optimistic scenario.

Catalysts and Risks: The Path to Approval

The trial data is in, but the real game now is navigating the regulatory path. Ocular Therapeutix plans to submit a New Drug Application based on the SOL-1 results, but that move is contingent on formal discussions with the FDA. The company has already stated it will pursue an NDA, subject to those planned talks. This sets up the next major catalyst: the topline readout from the SOL-R non-inferiority trial, expected in the first quarter of 2027. This trial is critical because it will provide additional data on the drug's durability and safety profile, which the FDA will scrutinize closely.

The key risk, however, is whether the agency will accept the 17.5% risk difference as sufficient for approval. While the trial met its superiority endpoint, the magnitude of the advantage is the very point that disappointed the market. In the competitive wet AMD landscape, where Eylea and other anti-VEGF drugs are entrenched, the FDA may demand a larger clinical benefit to justify a new label. The company's hope is that the robust durability data-showing 65.9% of Axpaxli patients maintained vision at Week 52 versus 44.2% for aflibercept-will be enough to demonstrate a meaningful treatment burden reduction. Yet, given the stock's reaction to the SOL-1 print, the market is already questioning if that benefit is large enough. The upcoming SOL-R readout and the NDA submission itself will be the next tests of whether the company can bridge the expectation gap.