Epion Therapeutics announced it was granted a new U.S. patent for a novel light therapy device as part of its EpiSmart Epithelium-On Cross-linking (CXL) System, designed to treat ectatic corneal disease (ECD).
Let’s start with this company.
Founded in 2012, the Burlington, Massachusetts-headquartered, late-stage, private biotech company was originally dubbed “CXL Ophthalmics, Inc.” before a name change in 2023.
Its purpose: Developing a minimally-invasive treatment for ECD—including keratoconus.
- And its current clinical focus involves a drug-device combination designed to fully utilize CXL and be implemented at initial diagnosis for disease progression prevention—a major distinction from other keratoconus treatments.
- Take note: This is the aforementioned EpiSmart Epithelium-On CXL System.
Break this system down for me.
As an investigational (as in, not yet FDA-approved) drug-device combo with 12 U.S. (and three European) patents, EpiSmart’s three components include:
- RiboStat (the drug) and ultraviolet A (UVA device; the drug delivery device)
- High concentration of riboflavin guides diffusion into the stroma (which provides structure to organs and tissues) and is an “ideal tonicity and pH for penetration through the intact epithelium.”
- Plus: A sodium iodide formulation removes peroxide to protect the cornea and riboflavin as well as “catalyzes the most favorable reactions for efficient [CXL].”
- High concentration of riboflavin guides diffusion into the stroma (which provides structure to organs and tissues) and is an “ideal tonicity and pH for penetration through the intact epithelium.”
- EpiPrep (drug delivery device)
- A disposable wand that promotes epithelial permeability without any disruptions—and includes a disposable loading sponge that maintains the drug’s concentration during stromal loading.
So how is the EpiSmart process unique, exactly?
The EpiSmart technology enables simultaneous treatment of both eyes while also potentially removing the need for additional deterioration.
And most importantly: It’s intended to cause no disruption to the epithelium and has no need for continuous dosing or supplemental oxygen.
- The company’s pitch: “EpiSmart is designed to offer safer, less invasive keratoconus treatment with rapid recovery.”
Sounds promising … but is there any clinical data to back it up?
Currently: Two phase 3 studies (NCT06100939 and NCT06100952) are evaluating the safety and efficacy of EpiSmart for keratoconus across 20 U.S. clinical sites.
Previously: A phase 2 program of >2,000 participants “received simultaneous, bilateral treatment and experienced a very low rate of adverse events [AEs].”
- “Bilateral treatment represents a significant advantage and convenience to patients,” the company noted.
Go on …
Specifically, the following was demonstrated through this phase 2 program:
- Corrected vision improvements over 12 months
- Favorable safety profile (of EpiSmart) with no serious AEs
- Low rate of reported pain and epithelial defects
- Rapid recovery (patients returned to work/school within 48 hours of treatment)
- Treatment of keratoconus at diagnosis without documented progression
- Simultaneous treatment of both eyes in > 70% of patients
Nice! So what’s next for the company?
Epion previously stated it expects to complete patient enrollment for the two phase 3 Apricity (A and B) trials by early 2025. And according to Clinical Trials, the studies are slated to conclude by Q4 2025.