Ocular Therapeutix said it plans to submit a new drug application for Axpaxli (formerly OTX-TKI), its intravitreal axitinib hydrogel implant, shortly after receiving 1-year data from the ongoing phase 3 SOL-1 trial, assuming the results are positive. The company cited recent statements from US Food and Drug Administration (FDA) officials suggesting that a single, well-controlled registrational trial may be sufficient for approval in certain settings. SOL-1 is being conducted under a special protocol assessment and is designed as a superiority study comparing Axpaxli with a single injection of aflibercept 2 mg (Eylea; Regeneron) as a treatment for neovascular age-related macular degeneration (nAMD).

The trial completed enrollment of 344 treatment-naïve patients in late 2024 and is evaluating the proportion of patients who maintain visual acuity at week 36, with durability data extending through week 52. Axpaxli is intended to extend treatment intervals to 6 to 12 months. Company executives said axitinib’s prior approval in oncology indications may allow use of the 505(b)(2) pathway.

Ocular Therapeutix expects that additional data from SOL-1’s second year and extension studies will inform clinical adoption and payor decision-making. The company said it plans continued discussions with the FDA regarding next steps in neovascular AMD. Axpaxli is also being studied for nAMD in the parallel global phase 3 SOL-R trial, which completed enrollment earlier this year, as well as for nonproliferative diabetic retinopathy.