Epion Presents Survey on Keratoconus Highlighting Need for Accessible Treatments

Jonathan H. Talamo, MD, Chair of the Board at Epion Therapeutics, presented findings at the Eyecelerator@AAO 2024 conference on the current state of keratoconus (KC) management in the United States, highlighting a critical gap in treatment for the progressive eye disease. Results from an Epion-sponsored survey indicated that a significant proportion of diagnosed KC patients are not receiving cross-linking treatment, the only FDA-approved intervention proven to halt disease progression.

The survey, conducted among US-based optometric practices that manage KC, revealed that these practices see an average of about 500 keratoconus patients each. However, only 30% of those patients have undergone cross-linking therapy, despite 80% of them being classified as having moderate or severe KC. "This means that large numbers of KC patients in this country are progressing and losing vision, but still not receiving treatment," Dr. Talamo said in a company news release.

According to Dr. Talamo, these findings underscore an unmet need for more accessible, patient-centered treatment options for keratoconus, especially those that can be administered earlier in the disease's progression.

“Early diagnosis and treatment of keratoconus should be the goal with any progressive disease, but the current FDA-approved cross-linking therapy has limitations. It requires documented worsening of the disease and involves corneal epithelium removal, leading to a slow, painful recovery and potential risks such as corneal haze, infection, and scarring," Dr. Talamo said. 

In response to this gap, Epion Therapeutics is developing EpiSmart, a next-generation cross-linking therapy currently undergoing phase 3 clinical trials. EpiSmart builds on Epion’s Epi-On cross-linking approach, which avoids epithelial removal. Key to the EpiSmart system’s efficacy is its novel Ribostat formulation—an advanced riboflavin and sodium iodide combination—that achieves effective stromal saturation without disturbing the corneal epithelium. The system's unique dual-head device design also eliminates the need for continuous dosing or supplemental oxygen, making it a more user-friendly solution for both patients and clinicians, according to Epion. 

According to Epion, phase 2 data have shown promising results, including:

• Improved corrected vision over a 12-month period
• Favorable safety profile, with no reported serious adverse events
• Rapid recovery: most patients returned to work or school within 48 hours
• Simultaneous bilateral treatment in over 70% of cases, allowing both eyes to be treated without documented progression

The phase 3 clinical trials, which are enrolling patients at more than 20 US sites, aim to further validate these outcomes. Epion expects to complete enrollment by early 2025.