Ocular Therapeutix announced that its investigational hydrogel, Axpaxli, outperformed Regeneron’s Eylea in maintaining vision for patients with wet age-related macular degeneration (AMD) during a late-stage clinical trial. The company now plans to consult with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Axpaxli and intends to submit an approval application.
In the Phase 3 SOL-1 study, Ocular enrolled 344 patients with wet AMD who had not received previous treatment. After an initial eight-week loading period using two doses of Eylea, participants were randomly assigned to receive either Axpaxli or continue with Eylea for another 36 weeks. At this point, 74.1% of those treated with Axpaxli lost fewer than 15 letters on a visual acuity chart from baseline, compared to 55.8% in the Eylea group—a difference described as statistically significant by Ocular.
The company continued monitoring patients up to 52 weeks and reported that 65.9% of those on Axpaxli maintained their vision gains, versus 44.2% among those treated only with Eylea. Exploratory endpoints such as fluid control and reduced need for rescue medication were also met by Axpaxli.
Analysts at William Blair commented on February 5: “We believe Ocular’s lead asset, Axpaxli, has the potential to represent a significant advance in the treatment of wet AMD.” In their note following Ocular’s full year 2025 earnings report, they described the SOL-1 results as “a major catalyst for the stock” and said it “significantly expedites a potential approval” for Axpaxli.
If approved by regulators, Axpaxli would become the first tyrosine kinase inhibitor available for treating wet AMD. Detailed findings from SOL-1 are scheduled to be presented at a medical conference later this month.
Ocular is also conducting another Phase 3 trial called SOL-R involving 631 patients to test whether Axpaxli is not inferior to Eylea. Enrollment for SOL-R was completed in March 2025, and topline data are expected in early 2027.
As of December 31, 2025, Ocular reported having $737.1 million in cash and equivalents, which it expects will support operations into 2028.
