A smarter, gentler approach to keratoconus is on the Fast Track with EpiSmart.
In a development that could make corneal cross-linking a little less “ouch” and a lot more efficient, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Epion Therapeutics’ (USA) EpiSmart epithelium-on cross-linking system.
Epion shares the news on its LinkedIn page.
The Massachusetts-based company’s novel device is designed to enable simultaneous, bilateral treatment for keratoconus, potentially changing how ophthalmologists tackle one of the leading causes of progressive vision loss worldwide.
“We are very pleased with and appreciate that the FDA recognizes EpiSmart’s potential to advance the standard of care for patients living with keratoconus,” said Michael Web, president and CEO of Epion Therapeutics, in a news release. “This designation furthers our efforts to prevent vision loss for millions worldwide who are threatened with vision loss from keratoconus.”
New approach to treating keratoconus
Traditional keratoconus treatment methods, such as epithelial-off (epi-off) corneal cross-linking, require removing the corneal epithelium to allow riboflavin penetration before ultraviolet (UV) activation. While effective in halting disease progression, this approach can be painful and carries risks like infection, delayed healing and corneal haze.
EpiSmart takes a gentler route. As an epithelium-on (“epi-on”) system, it strengthens the cornea without epithelial removal, offering a less invasive option that may reduce recovery time, discomfort and postoperative complications for patients.
The system also enables simultaneous bilateral treatment, potentially improving both clinical efficiency and the overall patient experience.
By facilitating earlier intervention—even in cases without documented progression—EpiSmart could broaden eligibility and address a significant unmet need in keratoconus management.
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Minimally invasive care
EpiSmart’s impact lies in its simplicity. Traditional corneal cross-linking often requires a surgical setting, topical anesthesia, and several days of postoperative recovery. By eliminating the need for epithelial debridement, EpiSmart’s epi-on approach could make the procedure shorter, more comfortable and potentially office-based, streamlining care for both patients and physicians.
Preliminary data from clinical investigations suggest that epithelium-on systems may provide comparable biomechanical strengthening to traditional epi-off methods while reducing discomfort and downtime. If ongoing trials continue to support these findings, EpiSmart could mark a paradigm shift in keratoconus management, moving from reactive treatment toward early, preventive intervention.
The takeaway
The FDA’s Fast Track designation for EpiSmart reflects ophthalmology’s continued drive toward smarter, more patient-friendly innovation—advances that prioritize efficacy without sacrificing comfort or accessibility. With keratoconus rates rising, particularly among younger and myopic patients, the demand for early, minimally invasive solutions is only intensifying.
As Epion Therapeutics continues to advance EpiSmart through clinical trials, the device stands as a reminder that the next leap in keratoconus care may not come from doing more, but from doing it more intelligently. If all goes as envisioned, the future of corneal cross-linking could be clearer, quicker and just a little kinder to the cornea.
Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.