Epion Therapeutics is conducting Phase 3 clinical trials for an investigational treatment called EpiSmart™. This minimally invasive procedure involves applying a riboflavin (vitamin B-2) solution to the cornea, followed by exposure to ultraviolet A (UVA) light. Unlike traditional methods, EpiSmart™ preserves the cornea’s outer layer, potentially reducing discomfort and speeding up recovery.  

What is EpiSmart Corneal Cross-Linking? 

EpiSmart is a type of epi-on cross-linking, where the cornea’s thin outer layer, called the epithelium, is left intact during treatment. This approach differs from traditional epi-off cross-linking, where the epithelium is removed. 

The EpiSmart treatment involves two simple steps: 

1. Riboflavin Application: Using a tiny sponge, the cornea is saturated with a study drug solution containing vitamin B-2 (riboflavin) and salt. 

1. UVA Light Exposure: The cornea is then exposed to ultraviolet A (UVA) light using a proprietary medical device. 

These steps result in a process called cross-linking, which stiffens the cornea to potentially prevent further shape changes that lead to vision impairment. 

What is the Goal of the EpiSmart Clinical Studies? 

The nationwide EpiSmart studies are designed to determine whether this investigational epi-on treatment is safe and effective compared to a placebo/sham treatment. A placebo/sham treatment mimics the study procedure but does not include active components, helping researchers accurately assess the treatment’s impact.  

Why Participate in the Study? 

Participants will: 

• Gain access to this investigational treatment at no cost. 

• Help advance keratoconus care and contribute to vital research. 

• Be compensated for their time and travel. 

To qualify, you must meet specific criteria, including being between the ages of 8 and 45, having a keratoconus diagnosis, and not having a history of eye surgeries. 

Learn More and Take Action 

To find out if you’re eligible and to learn more about the study, visit the Epion Therapeutics Patient Information Page.