Epion Therapeutics has received Fast Track designation from the FDA for the EpiSmart Epithelium-On Crosslinking (CXL) System.
Let’s start with Epion.
Headquartered in Burlington, Massachusetts, Epion is a late-stage, private biotech company developing a minimally-invasive treatment for ectatic corneal disease (ECD).
More specifically: The company’s goal in preventing vision loss is by targeting keratoconus, a common form of ECD.
And this treatment?
The aforementioned EpiSmart Epithelium CXL System is a drug-device combination intended to be utilized at the initial disease diagnosis to prevent further disease progression.
This investigational system is comprised of three components:
- A drug (RiboStat)
- A drug delivery device (EpiPrep)
- An ultra-violet A (UVA) device
Tell me about each of these.
We’ll start with EpiPrep, a disposable wand designed to enhance epithelial permeability without disruption.
- Its design involves a disposable loading sponge that maintains drug concentration during stromal loading
As for the drug itself (RiboStat) and UVA device, these consist of a high concentration of riboflavin that drives diffusion into the stroma—and reportedly has the ideal tonicity and pH for penetration through the intact epithelium.
- The drug’s sodium iodide formulation also:
- Removes peroxide to protect the cornea and riboflavin
- Catalyzes the most favorable reactions for efficient CXL
And how do they work together?
This is where the EpiSmart technology comes into play, in which it bilaterally (and minimally-invasively) treats both eyes—all while simultaneously removing the need for additional penetration.
Plus, it also:
- Causes no disruption to the epithelium
- Requires no need for continuous dosing or supplemental oxygen
And as an aside: Check out the details on a new partnership Epion just launched with OCULUS to support the development and manufacturing of the UVA device.
Sounds promising! So what does this designation mean for the system?
First, a quick rundown on Fast Track is in order.
What it is: Part of the FDA’s expedited program for investigational drugs that also includes Regenerative Medicine Advanced Therapy and Breakthrough designations.
Who can receive it: Companies looking to expedite the development and regulatory review process of an investigational therapeutic with the intention to treat serious medical conditions and fill an unmet clinical need.
- And a major advantage: Non-clinical data and/or preliminary clinical evidence aren’t required in a company’s submission request for Fast Track.
So how might this benefit Epion?
The designation translates to the company potentially being eligible for more frequent interactions with the FDA as it continues to make progress in advancing the EpiSmart system towards a possible regulatory submission—as well as a rolling review of its application package (once submitted).
What this means: A rolling review would allow Epion to submit its new drug application (NDA) for regulatory approval in stages rather than all at once.
- And if all relevant criteria are met, the company may also receive an accelerated approval timeline and priority review.
Nice! So where is the EpiSmart system in the clinical development process?
The technology is currently undergoing phase 3 clinical evaluations (see here for details on those) in two studies across the United States.
- Those trials are expected to conclude at the end of the year—with data likely to follow in 2026.
And in the meantime: Click here for details on the system’s phase 2 clinical performance so far.