OcuSciences, based in Ann Arbor, MI, has developed an instrument that will provide information to enable earlier diagnosis of eye conditions including glaucoma, diabetic retinopathy, and macular degeneration. Currently, in the case of diabetic retinopathy, it is only after being diagnosed with diabetes that a patient will begin to have their retinas checked regularly. Typically, the ophthalmologist utilizes structural imaging methods to look for leakage, hemorrhages, or other microvasculature changes. They determine at what point there are enough “little blotches” on the retinal images that suggest that there is an active disease state. However, by that time the disease has been active for many years and significant irreversible damage has occurred. OcuSciences’ technology is able to detect damage at the very early stages of diabetic retinopathy, glaucoma, and macular degeneration, empowering the physician to be proactive with the treatment and monitoring of these disorders.
OcuSciences’ device, the OcuMet Beacon, produces a rapid, quantitative, and non-invasive measure that will give a snapshot of a patient’s retinal health to clinicians. It can suggest the presence of disease 5-10 years earlier using a technology called Retinal Metabolic Analysis (RMA). OcuSciences’ founders discovered that when exposing the retina to a specific wavelength of blue light, mitochondrial-bound flavoproteins that were not contributing effectively to energy production in the cell, due to impairment by an underlying retinal disease, emitted green fluorescence. In contrast, healthy flavoproteins did not react to the light. The Beacon was developed to leverage this behavior to detect the progression of disease. The Beacon displays the results as a two-dimensional fundus image with the level of fluorescence displayed (shown to the right) so that damage can be localized. It also summarizes the data collected in the scan by providing an average fluorescence and a plot of the number of image pixels at each fluorescence intensity, showing the variance in the fluorescence throughout the image to assess heterogeneity. A high average intensity and a high variance are both signs suggesting possible disease.
Use of the Beacon requires a quick, non-invasive image of the eye without the need for injection of any dye or compound. The test takes only five minutes and can be performed in a clinical setting. The device has been used by a number of clinical sites for investigational purposes, and the technique has a half-dozen peer-reviewed publications showing promising results.
We had a chance to discuss the technology and future of OcuSciences with President and COO Kurt Riegger.
Allison Bedell, Medgadget: What is the story behind OcuSciences and the Beacon?
Kurt Riegger: Our company was founded as a spin-out of the University of
Michigan Kellogg Eye Center by Howard Petty and Victor Elner. Each of them has a background and clinical interest in assessing disease process on the cellular level. They developed a laboratory technique that they used to test retinal cells for response to oxidative stress based on analyzing the fluorescence of the mitochondrial-bound flavoproteins. When light of a particular wavelength is shown on them, the amount of fluorescence changes depending on the relative ‘health’ and ability of the flavoproteins to produce cellular energy. And because the retina is one of the most energetic tissues in the body, an issue in the mitochondria of the retina reveals a biomarker of early disease.
Initially we did some studies which found that people who have diabetes, including undiagnosed cases, experience significant damage to their retinal tissue. This damage is visible even before you begin to see it in other imaging modalities like OCT. We saw the opportunity to leverage Petty and Elner’s method to create a device that can detect a very early signature of disease using a quick test in the clinic.
The challenge was to take that concept and translate that into the human eye, an environment that is already very rich in other sources of fluorescence. Our device uses a very specific, narrow wavelength of light for the illumination and includes a very specialized optical train with a sensitive detector that will distinguish the faint signal coming specifically from the mitochondrial-bound flavoproteins without confusing it with the other sources of fluorescence. The amount of green fluorescence you’re getting back is very faint so you need a very efficient camera. Our detector and optical path efficiency is very high.
Medgadget: What is the advantage to diagnosing these patients sooner? What can be done?
Kurt Riegger: For many patients, it is difficult to diagnose certain eye conditions, such as glaucoma and macular degeneration, until certain disease signs present. RMA offers the ability to detect the earliest stages of these disease processes in order to implement treatment at a much earlier stage to prevent typical disease complications. In the
case of diabetes, it allows for earlier detection of eye damage in all diabetics and can even help detect the disease in undiagnosed diabetics and pre-diabetics. We find that showing a patient a quantitative measurement demonstrating that their eyes are being harmed is a powerful motivating tool. It also allows immediate feedback to the patient and clinician to assess if therapy is improving the retinal health, and can help the physician decide whether to increase the dose of a certain therapy or try alternative therapies. In addition, there are many drugs being developed for eye disease that are directly targeting mitochondrial function and oxidative stress mechanisms. Some of the clinical sites using our device already are pairing our measures with these new therapeutic actions. These new treatments have had some very good success, but now they are looking further into when to treat, how often to treat, and how aggressively to provide the therapy; our device is part of those trials.
Medgadget: What is your vision for the future of your device?
Kurt Riegger: Currently, our device is an adjunctive device that physicians use as part of a mosaic. Our next steps are FDA approval and while we are focused on ophthalmology and optometry, we would like to bring a smaller and simpler device into primary care doctors’ offices. Today, you get your blood pressure taken, your temperature taken, and your weight measured, and with our device, you’d also get a quick scan of your eye to evaluate the metabolic health of your retina. Our device could screen for patients who have undiagnosed cases of diabetes and pre-diabetes, patients who have developed gestational diabetes during pregnancy, and even patients whose medications for another condition are inadvertently affecting their retinal health—oftentimes these side effects go undiagnosed until the patient is approaching blindness. Our device could track a patient’s condition and intervene before there is significant damage.
More at: OcuMet Beacon…