EyeCool Therapeutics, Inc., a clinical-stage medical device company pioneering a novel approach for the treatment of ocular surface pain, recently 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 COSP.
Top-line results for the trial registered under NCT06479382 were first presented at the American European Congress of Ophthalmic Surgery (AECOS) Winter Symposium, demonstrating 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.
Full study results are on file at EyeCool Therapeutics and will soon be submitted for peer-reviewed publication.
"This milestone reinforces the potential of our novel technology to address a critical unmet need for patients suffering from COSP," said Dr. Ruben F. Salinas, president & CEO of EyeCool Therapeutics. "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, further confirming the potential for EyeCool's novel technology.
"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 ophthalmologist Preeya K. Gupta, MD, Cornea and Cataract surgeon at Triangle Eye Consultants, Raleigh, North Carolina.
Alice Epitropoulos, MD, an ophthalmologist at Central Ohio Eye & Plastic Surgery added, "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 and be quickly, easily, and conveniently applied."
From the patient's perspective, 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 COSP and are pleased to see this sign of progress."
About EyeCool's device (ETX-4143)
EyeCool's lead product, ETX-4143, is an investigational device for the treatment of COSP. It is designed to be used during an in-office, out-patient procedure. The device gently cools the surface of each eye for four 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 two to three months, symptoms may return and patients may require repeat treatment. In addition to pain relief, clinical trials have shown significant improvements in corneal sensitivity. EyeCool's product has not been approved or cleared for marketing by the U.S. Food and Drug Administration and is considered an investigational device.
About chronic ocular surface pain
Chronic ocular surface pain (COSP) is a common ocular condition defined as having a feeling of pain or discomfort, perceived as originating from the ocular surface, that persists for more than three months. There are currently no approved treatment options for COSP.
About EyeCool Therapeutics Inc.
EyeCool Therapeutics is a clinical stage medical device company committed to innovation and novel therapies for eye care. EyeCool is focused on developing an in-clinic device to deliver fast, lasting relief for patients suffering from Chronic Ocular Surface Pain (COSP).