Ocular Therapeutix reported that its intravitreal hydrogel Axpaxli (OTX‑TKI) met the superiority primary endpoint versus a low‑dose aflibercept (Eylea) in the Sol‑1 Phase 3 trial for wet age‑related macular degeneration. In the trial’s primary analysis at week 36, a higher proportion of Axpaxli‑treated patients maintained prespecified visual acuity compared with the active control under the trial’s Special Protocol Assessment. The company compared a single Axpaxli dose after a common loading phase to a standard aflibercept dose and reported 74% of Axpaxli patients maintained vision vs ~56% in the low‑dose Eylea arm at the primary timepoint. Ocular’s hydrogel delivers axitinib locally and the readout was designed to support a superiority label. Investors reacted sharply: shares fell after the announcement despite the positive topline, reflecting debate over real‑world commercial impact against established longer‑acting VEGF inhibitors and how the trial design maps to usual retina practice. Ocular will now evaluate regulatory steps and next commercial strategy in a market dominated by Regeneron and Roche products.
Get the Daily Brief