FDA Clears Novoxel's Tixel Device for Meibomian Gland Dysfunction Treatment

Novoxel has announced that its Tixel device has received FDA clearance for the treatment of evaporative dry eye caused by meibomian gland dysfunction (MGD). This milestone introduces a new approach to improving eye lubrication through localized heat and pressure application.

How Tixel Works: Thermo-Mechanical Action (TMA)

Tixel systems utilize Thermo-Mechanical Action (TMA) technology instead of light or laser energy, making it suitable for all skin tones and year-round use. This innovative system treats glands in both the upper and lower eyelids, enhancing the delivery of lubricating oils to the eye surface and addressing the root cause of evaporative dry eye.

Key Advantages:

       • No need for anesthesia.

       • No coupling gel or complicated applicators.

       • No bright flashes of light.

       • Simple and safe enough for staff to perform the procedure.

According to Gregg J. Berdy, MD, FACS, an ophthalmologist in St. Louis and part of the clinical study:

“The upper and lower eyelids of both eyes can be treated in less than 2 minutes. Most patients say their eyes feel more watery during the actual treatment.”

Clinical Study Results

A multi-site clinical study demonstrated significant benefits of Tixel for patients with MGD, including:

       • Improved objective scores: Enhanced tear breakup time (TBUT) and meibomian gland scores (MGS).

       • Reduced symptoms: Marked improvement in patient-reported symptoms, as measured by the Ocular Surface Disease Index (OSDI).

Treatment Regimen and Benefits

The Tixel treatment regimen includes three sessions, spaced two weeks apart, offering a quick and effective approach to managing MGD.

Tixel vs. Other Systems:

Tixel simplifies the treatment process with a patient- and practitioner-friendly design:

       • Quick procedure time: Both eyes treated in less than two minutes.

       • Straightforward operation without specialized equipment.

US Support and Availability

All sales, marketing, and technical support for Tixel products in the US are managed through Novoxel’s facility in Tennessee, ensuring a seamless experience for practitioners adopting the technology.

Conclusion

The FDA clearance of Tixel represents a major advancement in the treatment of evaporative dry eye and meibomian gland dysfunction. With its unique technology, ease of use, and proven effectiveness, Tixel provides a promising solution for patients and eye care professionals alike.