EyeCool Therapeutics debuted positive clinical findings from an Australian pilot study evaluating the use of its investigational device for the treatment of chronic ocular surface pain (COSP).
Let’s start with EyeCool.
Launched in 2021 and operating out of Cambridge, Massachusetts, the clinical-stage medical device company is exclusively focused solely on developing and testing a novel treatment of COSP patients.
- Check out its executive team.
Now a rundown on COSP.
What it is: A persistent pain that develops in the eye (and lasting +3 months) due to tissue damage on the ocular surface from ocular conditions such as:
- Corneal abrasion
- Neuropathic pain
- Dry eye
- Keratitis or uveitis
Even further: Other symptoms can include dryness, burning, irritation, foreign body sensations, light sensitivity, and itching at the ocular surface—plus low tear production, chronic inflammation, or nerve abnormalities.
- The impact: Difficulty in completing everyday tasks requiring vision (i.e., digital device usage, reading, and driving).
Leading to the issue: While current treatments like topical and oral medications are often used, there is currently an unmet need for a more targeted therapy to effectively address this pain.
Next: this device.
As the company’s lead investigational product, ETX-4143 is designed to be used as an in-office and out-patient procedure for COSP treatment.
- How it works: The device is applied to gently cool the surface of each eye for 4 minutes, delivering a targeted and precise dose of thermal energy.
- What this does: Targets the myelinated long ciliary nerves (which carry sensory information from the eye to the brain, leading to COSP-associated pain).
Click here for a visual of this procedure.
How soon can patients experience pain relief?
Immediately, EyeCool reports.
And in the weeks following treatment, this relief is intended to improve—though repeat treatment may potentially be needed 2 to 3 months post-treatment.
- Why: The treated nerve fibers “gradually regenerative myelin,” causing symptoms to return, according to EyeCool.
Gotcha. Moving on to this clinical trial.
Per Clinical Trials, the prospective early-feasibility study (NCT06479382) evaluated the safety and efficacy of the ETX-4143 device when used to treat patients with COSP who achieved no relief from prior medications or treatments.
- The participants: 31 patients (30 eyes; aged 22 to 90)
- The setup: Patient eyes’ randomized 2:1 to receive either the investigational device or a sham treatment
- The outcome measures: Measured at 8 weeks, these included:
- Patient-reported reduction in eye pain
- Adverse events relating to treatment
And the findings?
To start: The study demonstrated a favorable safety profile as well as a significant reduction in patient-reported ocular surface pain scores (versus sham treatment).
Was this eye pain reduction statistically significant?
Yes it was—and this was determined based on data obtained from “a recently validated [COSP-designed] patient reported outcome instrument.”
Take note though: This achievement wasn’t actually targeted, as the study itself was not “powered for statistical significance.”
Sounds like an added bonus. Any other data released?
Not so far. The company reported that the full study results are expected to soon be submitted for peer-reviewed publication (though no specific timeframe or journal name were provided).
And the plan moving forward?
Next up: EyeCool President and CEO Ruben F. Salinas, PhD, shared plans to conduct a large U.S. pivotal trial—cointingent on the company receiving the FDA’s approval of an investigational drug exemption (IDE).
Why an IDE is key: This essentially enables an investigational device to be used in a U.S. clinical study so safety and effectiveness data can be collected.
And why would an IDE be needed?
For the company’s endgame goal: Submitting a De Novo classification request (once that aforementioned U.S. trial is completed).
Refresh on this: A De Novo classification is a “risk-based classification process” for providing a marketing pathway to classify novel medical devices that “provide reasonable assurance of safety and effectiveness for the intended use.”
A couple of notes:
- There must also not be a predicate device—a device that’s already legally marketed for the same intended use.
While this request is similar to a 510(k) clearance in that they’re both market pathways for medical devices with low to moderate risk (Class I or Class II), a 510(k) relies heavily on determining a “substantial equivalence” to an existing medical device