A clinical-stage medical technology company, EyeCool Therapeutics, has announced positive results from a pilot study of its investigational device ETX-4143, designed to treat chronic ocular surface pain (COSP), a persistent symptom often associated with dry eye disease.
The Cambridge, Massachusetts-based company conducted a pilot-stage, randomized, double-masked study (NCT06479382) involving 31 patients in Australia. While not powered for statistical significance, the trial demonstrated a statistically significant reduction in eye pain severity using a recently validated patient-reported outcome instrument specifically designed for COSP.
Novel Cooling Mechanism Targets Pain Pathways
ETX-4143 employs a unique approach to pain management by gently cooling the surface of each eye for four minutes during an in-office outpatient procedure. This cooling action specifically targets the myelinated long ciliary nerves associated with ocular pain.
According to the company, most patients experienced immediate relief following the procedure, with effects lasting and even improving over subsequent weeks. As treated nerve fibers gradually regenerate myelin over a period of 2-3 months, patients may require retreatment when symptoms return.
Dr. Ruben F. Salinas, President & CEO of EyeCool Therapeutics, emphasized the significance of these findings: "This milestone reinforces the potential of our novel technology to address a critical unmet need for patients suffering from COSP."
Addressing an Underrecognized Condition
Chronic ocular surface pain represents a significant but often misdiagnosed condition. Rebecca Petris, co-founder and president of the non-profit Dry Eye Foundation, highlighted this challenge: "For most patients with dry eye disease, persistent pain is a major outcome which negatively impacts daily life activities. Patients often describe their symptoms as burning, grittiness, light sensitivity, irritation, a dry feeling or with other words, but the missing link is that these are all pain symptoms."
Dr. Preeya K. Gupta, a cornea and cataract surgeon at Triangle Eye Consultants in Raleigh, North Carolina, noted that COSP "is a condition that often goes undiagnosed or is misdiagnosed as dry-eye and therefore leaves patients entirely untreated." She added that ETX-4143 would be a "very welcome addition" to the landscape of ocular surface therapies.
Clinical Benefits Beyond Pain Relief
In addition to alleviating COSP, patients treated with ETX-4143 may also experience improvements in corneal sensitivity, according to the company. This suggests potential broader therapeutic benefits beyond pain management.
Dr. Alice Epitropoulos, an ophthalmologist at Central Ohio Eye & Plastic Surgery, emphasized the current treatment gap: "There is an unmet need for new treatments that can safely and effectively manage COSP. I would be thrilled to finally have an option for these patients that could work seamlessly into my practice."
Path Forward for Clinical Development
Following these promising results, EyeCool Therapeutics plans to initiate a large U.S. pivotal trial upon receiving FDA Investigational Device Exemption (IDE) approval. The company aims to further evaluate the device's safety and efficacy with the goal of submitting a De Novo classification request upon trial completion.
The full study results are on file at EyeCool Therapeutics and will soon be submitted for peer-reviewed publication. The initial findings were first presented at the American European Congress of Ophthalmic Surgery Winter Symposium in February in Aspen, Colorado.
Last month, expert physicians and patient advocates presented on the significant unmet need in COSP patients at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting, further highlighting the importance of developing effective treatments for this condition.
