EyeCool Therapeutics Reports Positive Trial Results for Chronic Ocular Surface Pain

EyeCool Therapeutics, Inc., based in Cambridge, Massachusetts, has unveiled encouraging findings from a pilot study conducted in Australia involving its ETX-4143 device, which is being tested for efficacy and safety in managing chronic ocular surface pain (COSP). Involving 31 patients, this double-masked, randomized controlled trial showcased a positive safety profile and notable reductions in pain scores reported by patients, compared to those in the control group. Although the study was not designed to be statistically decisive, a significant decrease in pain severity was observed when using a specialized patient-reported outcome tool for COSP. The complete findings have been documented at EyeCool Therapeutics and are awaiting submission for peer-reviewed publication.

Dr. Ruben F. Salinas, the President and CEO of EyeCool Therapeutics, emphasized the importance of these findings, stating that the technology has the potential to meet a critical need for COSP patients. Based on these results, the company plans to launch a pivotal trial in the United States, pending FDA Investigational Device Exemption (IDE) approval, to further investigate the device's effectiveness and safety. Ultimately, EyeCool aims to submit a De Novo classification request upon the trial's conclusion.

The urgency for innovative treatments for COSP was also highlighted at a recent American Society of Cataract and Refractive Surgery meeting, where medical professionals and patient advocates underscored the unmet needs of COSP patients. Dr. Preeya K. Gupta, an ophthalmologist and cornea and cataract surgeon, remarked that chronic ocular surface pain is often misdiagnosed as dry eye, leaving patients without treatment options. She expressed optimism about EyeCool's device, which could provide a much-needed solution. Similarly, Dr. Alice Epitropoulos, another leading ophthalmologist, emphasized the safety and effectiveness of new treatments like ETX-4143 in addressing COSP, noting the ease of integrating such solutions into clinical practice.

From a patient's perspective, Rebecca Petris of the Dry Eye Foundation highlighted how the persistent pain associated with dry eye significantly impacts daily life. She pointed out that symptoms frequently described by patients, such as burning or grittiness, are fundamentally pain-related. Petris stressed the importance of industry and research focusing directly on COSP to improve patient outcomes and welcomed EyeCool's progress in this area.

The ETX-4143 device offers a novel approach to treating COSP. It involves an outpatient procedure where the device cools the surface of the eyes for four minutes, targeting the myelinated long ciliary nerves responsible for pain. Patients typically experience immediate relief, which continues to improve over subsequent weeks. However, as nerve fibers regenerate over two to three months, symptoms may recur, necessitating repeat treatments. In addition to alleviating pain, the device has shown significant improvements in corneal sensitivity during trials. Currently, the ETX-4143 device is classified as investigational and has not yet received marketing approval from the U.S. Food and Drug Administration.

Chronic ocular surface pain is a prevalent condition, characterized by persistent eye discomfort that lasts over three months, with no approved treatments presently available. EyeCool Therapeutics, committed to advancing eye care innovations, is dedicated to developing effective, in-clinic devices to provide rapid and lasting relief for COSP sufferers.