EyeCool Therapeutics Announces Results of Pilot Study of Novel Chronic Ocular Surface Pain Treatment

Author: Hattie Hayes

Key Points

• EyeCool Therapeutics’ ETX-4143 device demonstrated positive results in a pilot study for the treatment of chronic ocular surface pain (COSP).

• The device targets myelinated long ciliary nerves, providing rapid and lasting pain relief, and may improve corneal sensitivity.

Clinical-stage medical technology company EyeCool Therapeutics, based in Cambridge, Massachusetts, has announced positive results from a pilot study on its investigational ETX-4143 device for the treatment of chronic ocular surface pain (COSP).

According to the company, this randomized, double-masked pilot study (NCT06479382) was conducted in 31 patients in Australia. The initial results were presented at the American European Congress of Ophthalmic Surgery Winter Symposium in Aspen, Colorado, and published in a press release in May. The study evaluated the safety and efficacy of ETX-4143 in patients with COSP—often a persistent symptom in dry eye disease.

The ETX-4143 is an investigational device designed for use in a brief, in-office outpatient procedure. The device gently cools the surface of each eye for four minutes. This cooling targets the myelinated long ciliary nerves that are associated with ocular pain. EyeCool Therapeutics reported that most patients experienced immediate pain relief as well as longer-lasting improvements over the following weeks.

Although the study was not powered for statistical significance, EyeCool Therapeutics reported a statistically significant reduction in eye pain severity. The device’s performance was measured using a recently validated patient-reported outcome instrument specifically developed for COSP. The full results are on file with the company and will be submitted for peer review in the near future.

The company noted that treated nerve fibers gradually regenerate their myelin; as a result, after 2 to 3 months, patients may require repeat treatments if symptoms recur. Apart from pain relief, patients treated with ETX-4143 might also experience improvement in corneal sensitivity.

Rebecca Petris, co-founder and president of the nonprofit Dry Eye Foundation, remarked:

“For most patients with dry eye disease, persistent pain severely impacts their quality of life. Patients often describe their symptoms as burning, grittiness, photophobia, irritation, or dryness—essentially, all symptoms of pain. For better outcomes, we need more targeted research and industry engagement specifically in chronic ocular surface pain, and we welcome this progress.”

Preeya K. Gupta, MD, cornea and cataract surgeon at Triangle Eye Consultants, North Carolina, stated that ETX-4143 would be a “very welcome addition” to the existing armamentarium for ocular surface disease:

“Chronic ocular surface pain is a common complaint bringing patients to ophthalmologists, but it often goes undiagnosed or is misdiagnosed as dry eye, leaving patients untreated.”

Alice Epitropoulos, MD, ophthalmologist at Central Ohio Eye & Plastic Surgery, added:

“There is a clear unmet need for new treatments that can safely and effectively manage COSP. Having a reliable new option would be a significant advancement for patient care.”

Reference:

EyeCool Therapeutics announces promising results from double-masked randomized controlled trial in chronic ocular surface pain (COSP). Press release. EyeCool Therapeutics. May 7, 2025. Source link