Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.
Ocular Therapeutix’s investigational hydrogel Axpaxli beat out Regeneron’s Eylea at maintaining vision in a late-stage study of wet age-related macular degeneration. With these findings, Ocular now plans to meet with the FDA to determine a regulatory path forward for Axpaxli and to file an approval application thereafter.
In a Feb. 5 note, sent after Ocular’s full year 2025 earnings report, analysts at William Blair called the SOL-1 readout “a major catalyst for the stock” as it “significantly expedites a potential approval” for Axpaxli.
In the Phase 3 SOL-1 study, Ocular compared Axpaxli to Eylea in 344 patients with wet age-related macular degeneration (AMD) who hadn’t received prior treatment. Participants first went through an eight-week loading period, during which they received two doses of Eylea and reached peak treatment response—resulting in a study sample that “was specifically selected to lose vision,” the biotech said in Tuesday news release.
Patients were then randomly given Axpaxli or Eylea and followed for another 36 weeks, at which point 74.1% of those who were treated with Ocular’s hydrogel lost fewer than 15 letters on a visual acuity chart from baseline, indicative of maintaining vision. In comparison, 55.8% of patients who had only received Eylea hit this outcome, a statistically significant effect in favor of Axpaxli.
Ocular continued to follow patients through 52 weeks of follow-up and found that 65.9% of patients were able to maintain their vision gains at that time point versus 44.2% of Eylea comparators—an effect that was also statistically significant, the biotech said. Axpaxli also hit exploratory endpoints, including fluid control and the need for rescue medication.
If approved, Axpaxli would be the first tyrosine kinase inhibitor for wet AMD. The biotech will present detailed findings from SOL-1 at a medical conference later this month.
Ocular is also running the complementary Phase 3 SOL-R study, a three-arm trial of 631 wet AMD patients looking at the non-inferiority of Axpaxli to Eylea. The biotech completed enrollment for SOL-R in March 2025 and expects topline data in the first quarter of 2027, according to its Tuesday release.
“We believe Ocular’s lead asset, Axpaxli, has the potential to represent a significant advance in the treatment of wet AMD,” William Blair said in its Feb. 5 note.
As of Dec. 31, 2025, Ocular had $737.1 million in cash and equivalents, enough to keep business going into 2028.
