New products increase the chance of early diagnosis
Insightful new products are beginning to appear in the marketplace that will lead to an easier diagnosis of glaucoma at earlier stages with the goal of preventing visual field deterioration.
Neeru Gupta, MD, PhD, MBA, professor and Dorothy Pitts chair; chief of Glaucoma, Department of Ophthalmology and Vision Sciences, University of Toronto, and Robert N. Weinreb, MD, chairman and distinguished professor of ophthalmology, director of the Shiley Eye Institute and director of the Hamilton Glaucoma Center, guided industry professionals through discussions of the current and upcoming products at the Glaucoma 360 annual meeting.
Because Goldmann applanation tonometry provides only a snapshot of the intraocular pressure (IOP) at the moment of measurement, the peak IOPs most likely are missed. Implandata Ophthalmic Products GmbH is looking at continuous IOP monitoring in the hopes of preventing axonal damage, according to Kaweh Mansouri, MD, chief medical officer of Implandata Ophthalmic Products GmbH.
The eyemate reader is a device that measures IOP in a few seconds when the patient holds it in front of their eye. The reading, which is done by a sensor that is implanted in the sulcus during cataract surgery, is displayed on a reader and stored automatically. The eyemate has been granted regulatory approval in Europe.
The data obtained from patients will allow the development of personalized patient profiles to individualize glaucoma management, Mansouri explained.
The company is also developing a suprachoroidal device for implantation during filtering glaucoma surgery that measures IOP in the suprachoroidal space. The device is positioned close to the optic nerve and may show that the IOP at that location may be more relevant to the glaucomatous damage that occurs.
Work is ongoing to miniaturize the device and integrate it into an artificial intelligence (AI) platform. A smart intraocular lens-based sensor and an injectable IOP sensor are in the pipeline in the near future as is a closed-loop device to integrate IOP measures and release of treatment.
David Pennington introduced Novai’s DARC Technology (Detection of Apoptosing Retinal Cells), which can predict patients at the highest risk of disease progression by detecting apoptosis in retinal cells. DARC combines a biomarker with an AI algorithm to identify affected retinal cells, and the algorithm provides an automated measure of disease activity.
“The technology ‘de-risks’ clinical development of age-related macular degeneration and glaucoma therapeutics,” he said.
The algorithm is intended for use by pharmaceutical and biotech companies to optimize drug development and improve patient outcomes and to answer questions during drug development about the effectiveness of drug candidates, most effective drug dose, patient disease progression and rate of progression, and identification of patients with the most active disease.
“Finding the answers to these questions quickly and accurately is vital to research success. Early detection and automated diagnosis can lead to improved patient outcomes,” Pennington said.
DARC Technology uses a fluorescent-labeled annexin V protein injected intravenously to identify apoptosis based on early structural changes in the cell membrane. The endpoint is individually labeled cells that are seen as white spots on the retina, he explained.
“The technology facilitates prompt early assessment of drug efficacy predicted to be at high risk of progression,” Pennington said, adding that this can show drug efficacy in weeks rather than years.
The technology has been approved as an exploratory biomarker by the FDA and Medicines and Healthcare products Regulatory Agency.
Kurt Riegger, president and chief operating officer of OcuSciences, reported that the company is developing a rapid noninvasive marker-free ocular imaging technique (i.e., flavoprotein fluorescence) to quantitatively measure mitochondrial dysfunction for use in ophthalmology and optometry clinics. In contrast to current imaging technologies, flavoprotein fluorescence is being developed to detect retinal diseases, such as diabetic retinopathy, age-related macular degeneration, and glaucoma, early before irreversible apoptosis becomes visible.
The technology, OcuMet Beacon, uses a blue wavelength of light to excite flavoproteins that fluoresce if they are excitable. The degree of fluorescence is correlated with mitochondrial dysfunction.
This technology has the potential to be an early intervention to detect oxidative stress and combined with optical coherence tomography to initially determine patient status.
Alberto Gonzalez-Garcia, MD, chief executive officer of Olleyes, Inc., described a new device, VisuALL (Olleyes, Inc), that is designed for standardized and mobile assessment of the visual field. The device automatically analyzes the retinal sensitivity in patients with glaucoma and other visual and neurologic disorders. Multiple patients can be examined at once, thus increasing office productivity.
The virtual-reality head-mounted device has eye tracking and a microprocessor, the data are collected in the cloud to improve analysis of the psychophysical testing, and physicians can interact with the system review data and test selections. The advantages are the ability to test patients in different positions, eye tracking, and personalization of tests.
“All of this will improve patient compliance with the test and in turn improve the test quality,” he said.
Initial testing with the device compared with the standard of care showed very favorable results, Gonzalez-Garcia added. Ultimately, the goal is to perfect the device to the point that it can be used anywhere by patients.
Vivid Vision, Inc has developed a perimetry algorithm that allows patients to monitor glaucoma at home, according to James Blaha, founder and chief executive officer of Vivid Vision, Inc.
“This allows tracking of glaucoma progression faster than it could be done previously,” he said.
The company’s newest iteration of the technology uses an affordable mobile virtual reality headset to monitor glaucoma.
“It combines the physical comfort of virtual reality and the ability to perform the test in patients’ homes with totally new psychophysics at low cost, about $150 for the hardware,” he said.
The device is also easy to use and employs principles from video game designs to make the test enjoyable, rather than a chore. About 20 times more data are obtainable compared with the standard automated perimetry twice-annual test.
“By performing the test 4 times annually at home, we are able to classify the patients much more quickly than is possible based on the data obtained only in the clinic,” he said. “This allows detection of glaucoma progression when patients have lost only 1 decibel rather than 4 decibels.”
The company currently has more than 350 providers of the treatment platform worldwide.
A new noninvasive technology, Zilia Ocular, has been developed by Zilia that uses imaging spectrometry and AI to measure biomarkers in the eye beginning with oxygenation in real time, said Patrick Sauvegeau, OD, MSc, chief operating officer of Zilia.
In contrast to current imaging platforms that provide structural information about the eye, this technology provides accurate continuous measurements of ocular oxygenation, which informs clinicians about metabolic activity in tissues and allows better management of ocular diseases, such as glaucoma, he explained.
The user can target specific locations for the oximetry measurements, which are performed in areas that are 200 μm diameter. This is accomplished by having the patient look at a fixation target; light emitted from the device travels through the eye and reflects on the ocular fundus and returns to the device. The light signal is analyzed to provide a series of ocular images and oxygen saturation measurements. The use of a continuous light spectrum makes the measurements quantitative and allows the exploration of more biomarkers.