EyeCool Therapeutics Announces Positive Results from Pilot Study in Patients with Chronic Ocular Surface Pain (COSP)
EyeCool Therapeutics announced positive clinical data from a double-masked, randomized controlled pilot study of 31 patients in Australia evaluating the safety and efficacy of its investigational device (ETX-4143) for the treatment of Chronic Ocular Surface Pain (COSP).
Topline results for the trial (NCT06479382), first presented at the American European Congress of Ophthalmic Surgery (AECOS) Winter Symposium, demonstrated a favorable safety profile and a significant reduction in patient-reported ocular surface pain scores compared to control. While the study wasn't powered for statistical significance, a statistically significant reduction in eye pain severity was observed using a recently validated patient reported outcome instrument specifically designed for COSP, according to EyeCool.
Full study results are on file at EyeCool Therapeutics and will soon be submitted for peer-reviewed publication.
ETX-4143 is designed to be used during an in-office, out-patient procedure. The device gently cools the surface of each eye for 4 minutes, targeting the myelinated long ciliary nerves responsible for pain. Most patients experience immediate relief, which continue to improve over the following weeks. As the treated nerve fibers gradually regenerate myelin over 2 to 3 months, symptoms may return and patients may require repeat treatment.
"This milestone reinforces the potential of our novel technology to address a critical unmet need for patients suffering from COSP," Dr. Ruben F. Salinas, President & CEO of EyeCool Therapeutics, said in a company news release. "Building on these promising data, we plan to initiate a large U.S. pivotal trial upon receipt of FDA IDE approval to further evaluate the device's safety and efficacy, with the goal of submitting a De Novo classification request upon trial completion." Last month, expert physicians and patient advocates presented the significant unmet need in COSP patients at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting.
"Chronic ocular surface pain is a common complaint that brings many patients to see an eye doctor, however it is a condition that often goes undiagnosed or is misdiagnosed as dry eye and therefore leaves patients entirely untreated. Currently, we have no viable options to offer these patients, and as a physician, having a solution such as the one being developed by EyeCool would be a very welcome addition," said Preeya K. Gupta, MD, Cornea and Cataract surgeon at Triangle Eye Consultants, Raleigh, North Carolina.
Rebecca Petris, co-founder and president of the non-profit Dry Eye Foundation, noted that, "for most patients with dry eye, the biggest problem is the persistent pain that affects their 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. For better patient outcomes, we need to see research and industry engaging specifically with Chronic Ocular Surface Pain and are pleased to see this sign of progress."