Brill Engines, S.L., a subsidiary of Brill Pharma, announced the FDA approval of its Corneal Esthesiometer Brill (CEB).
Let’s start with these companies.
Based in Barcelona, Spain, Brill Pharma is a pharmaceutical laboratory specializing in research, development, and commercialization of research & development products within the ophthalmology space, including:
- Dry eye
- Age-related macular degeneration (AMD)
- Ocular allergy
- Eyelid and cornea care
- Diabetic macular edema (DME)
Launched in 2019, Brill Engines is focused on developing, registering, industrializing, and marketing eye care products on an international scale.
Now this product.
The CEB is a first-of-its-kind portable, manual and non-invasive device designed to measure corneal sensitivity.
Watch a visual on it here.
What is it indicated for?
Per the company, the device is indicated to detect subclinical dysesthesia and related pathologies like diabetic keratopathy or lesions in the fifth cranial nerve.
How does it work?
The electromedical device uses a controlled pulse of air to evaluate corneal sensitivity where it stimulates the cornea at constant pressures and ascending gradients—available with five grades of stimulation both above and below the physiological level.
The intent is to effectively detect corneal hyperesthesia and hypoesthesia.
What other features does it have?
Notable features include:
- Electronic positioning system (one camera and two infrared LEDs)
- 2 available modes to be used in (on a slit lamp and hand-held)
- Included battery and charging dock
- Non-contact (between the esthesiometer and patient’s cornea)
According to the company, no calibration maintenance is needed and there is no need to purchase replacement batteries.
Gotcha. What’s the clinical data on it?
Recent research on the device includes testing in dry eye disease (DED) patients and patients on hypotensive drops as well as an assessment of the safety of measurements taken with it.
In the first study, investigators concluded that the esthesiometer could be an easy-to-use device to evaluate patients with subclinical neurotrophic keratopathy (NK).
The second study concluded that, while more studies are needed to confirm the device’s efficacy in a more diverse population, the Brill Engines device was an easy, non-invasive, and portable alternative to another brand (Cochet-Bonnet).
What else?
The device has reportedly undergone clinical studies in the past at institutions such as Bascom Palmer Eye Institute and Duke University.
For 2024, Harvard Medical School, Johns Hopkins University, Tufts Medical Center, and Baylor College of Medicine are set to perform testing.
How does it benefit ECPs?
For optometrists, it may benefit during the contact lens adaptation process as well as for monitoring the loss of corneal sensitivity associated with overnight orthokeratology (ortho-k), according to Brill Engines.
For both optometrists and ophthalmologists, it can help diagnose and inform the appropriate treatments for various ocular diseases at an early stage such as neurotrophic keratitis.
Additionally, the CEB might aid in the evaluation of the effectiveness of a given treatment via follow-up assessment of the patient’s corneal sensitivity.
When will it be available?
Per the company, the device is expected to launch in both Europe and the United States in September 2023.
Stay tuned for further details!