Ocular Therapeutix, Inc. has successfully completed a pre-new drug application (NDA) meeting with the FDA supporting its investigational candidate AXPAXLI (OTX-TKI) for wet age-related macular degeneration (AMD).
First, let’s get reacquainted with this asset.
AXPAXLI is an investigational, bioresorbable hydrogel intravitreal (IVT) implant with anti-angiogenic properties.
What it does: continuously delivers axitinib—an FDA-approved, small-molecule, multi-target tyrosine kinase inhibitor (TKI)—for wet AMD and other vascular endothelial growth factor (VEGF)-mediated retinal diseases (see here for the latest phase 3 nonproliferative diabetic retinopathy [NPDR] trial update).
- This delivery is via a 25G needle, with a target release window of 9 to 12 months.
- It’s also biocompatible and tunable for use across multiple locations in the eye.
And what enables it?
That would be ELUTYX, the company's patented bioresorbable polymer hydrogel matrix, designed for localized sustained release to maximize therapeutic efficacy while minimizing systemic exposure. Read up on this established hydrogel platform that offers:
- Continuous and consistent drug delivery over days, weeks, or months
- Biocompatible versatility, therefore tunable for use in various locations within the eye
Now for a closer look at this wet AMD indication.
Consisting of three registrational trials, the ongoing phase 3 SOL program is evaluating AXPAXLI for wet AMD. Those studies include:
- SOL-1 (NCT06223958): initiated in 2023 and operating under a modified Special Protocol Assessment (SPA) through the FDA
- SOL-R (NCT06495918): enrolled first patients in 2024
- SOL-X (open-label extension with 3-year follow-up)
The intent: The SOL program is seeking to enable more infrequent AXPAXLI IVT dosing, with a target of just one to two injections per year.
And the data thus far?
AXPAXLI has been the subject of several positive data readouts, with investigators referring to it as having “unmatched (durability) in the wet AMD space while demonstrating excellent sustained disease control.”
- Check out our recap of 12-month topline data based on a single injection of AXPAXLI versus aflibercept.
- See here for positive phase 3 superiority data from the SOL-1 study released earlier this year (as well as additional findings here).
Next up: this pre-NDA update.
As we mentioned, Ocular announced the “successful completion” of its pre-NDA meeting with the FDA regarding AXPAXLI’s wet AMD indication.
Based on its outcome: The company remains on track to submit AXPALI’s NDA in Q4 2026 (translation: between Oct. 1 and Dec. 31).
This update also reportedly follows a May 2026 Type C meeting the company held with the federal agency.
What should we know about this planned submission?
The package will include efficacy and safety data from SOL-1 and interim safety data from SOL-R as well as supporting confirmatory evidence.
And as Ocular’s Executive Chairman, President, and CEO Pravin U. Dugel, MD, stated: “Our submission will include subjects that have received multiple AXPAXLI injections in support of our application for repeat dosing.”
And once under FDA review?
It’s worth noting that AXPAXLI’s NDA will be submitted under the FDA’s 505(b)(2) pathway.
What this is: a drug approval route through the federal agency that enables companies to partly rely on prior clinical findings used to support prior FDA-approved drugs—effectively speeding up the clinical review process.
- In this case: AXPAXLI’s axitinib (its active ingredient) has already received regulatory approval for non-ophthalmic indications.
So in this case, what’s the potential for AXPAXLI?
The FDA’s review timeline could be shortened by up to 60 days compared to the FDA’s standard 505(b)(1) NDA pathway—which is typically within 10 months (or 6 months if granted priority review).
As for the big-picture potential: If approved, AXPALI could become the first TKI commercialized for wet AMD—and the “only therapy with a superiority label and best-in-disease durability."
Got it. And in the meantime … any other updates to keep in mind?
The company also shared that it’s on schedule to conduct an interim SOL-R safety analysis for AXPAXLI sometime in Q4 2026.