Ocular Therapeutix said its intravitreal Axpaxli (OTX‑TKI) met the superiority primary endpoint versus a low-dose aflibercept (Eylea) comparator in the Sol‑1 Phase III trial for wet age-related macular degeneration. In the trial, 74% of Axpaxli recipients maintained prespecified visual acuity thresholds at week 36 versus roughly 56% in the Eylea arm, meeting the company’s Special Protocol Assessment–aligned analysis. Axpaxli is a bioresorbable hydrogel delivering the TKI axitinib; company releases and topline summaries described statistical significance across primary and several secondary measures. Despite the positive readout, Ocular shares fell on investor concerns over the commercial margin of benefit versus established anti‑VEGF treatments and on the trial’s active-control design. Management says the data position Axpaxli for regulatory submission discussions, but analysts flagged the high performance of the low‑dose Eylea arm and questioned market uptake against current long‑acting options. Ocular has signaled intent to pursue regulatory filings pending full dataset review.
Get the Daily Brief