The FDA has granted regulatory clearance to OcuSciences, Inc. for its flagship device: OcuMet Beacon, a non-invasive tool for evaluating retinal health.
First up: this company.
Launched in 2008 and headquartered in Ann Arbor, Michigan, OcuSciences is a commercial-stage biotechnology company developing proprietary technologies (ocular [retinal] imagers) and next-gen solutions for ocular health.
How it’s doing this: Via the use of advanced optical coherence tomography (OCT) and funduscopic imaging of the eye to develop retinal imagers that identify metabolic dysfunction within the retina.
- And the goal with these developments: To enable earlier detection of ocular diseases.
And what are these technologies focusing on to do this?
Two words: mitochondrial (dys)function.
Why: Mitochondria have a key role in maintaining cellular energy homeostasis—especially at the photoreceptor level. As such, the retina is highly susceptible to mitochondria-related damage.
With this in mind: Mitochondria dysfunction is closely associated as a precursor to apoptosis (cell death), and is—most importantly—implicated in a number of retinal diseases and disorders.
- Examples of these: diabetic retinopathy (DR); age-related macular degeneration (AMD); and glaucoma
So how does OcuSciences’ flagship device address this?
To note: OcuMet Beacon is one of two technologies the company has developed (with the other, OcuMet Mariner, still in preclinical stages).
What it is: An automated, rapid retinal imager designed to assess mitochondrial function and provide a noninvasive mechanism for rapid (and painless) images of the eye.
How it does this: By detecting the degree of flavoprotein fluorescence (FPF)—a notable and extensively-studied precursor to retinal cell death—via proprietary technology and advanced software to assist clinicians in identifying early markers of ocular disease.
What uses is this indicated for?
The confocal scanning ophthalmoscope is indicated for both infrared (IR) and autofluorescence (AF) imaging of the human retina with—and without—the use of a mydriatic agent.
Now get into specifics on this imager.
The OcuMet Beacon utilizes OcuSciences’ OcuMet Signature technology—its proprietary and patented illumination and detection technology—to capture a naturally occurring fluorescence from the eye.
What this involves:
- A touch-based tablet screen (requiring minimal training and a quick setup)
- Advanced software to enable visualization of the functional image signature
And keep in mind: No injections, dyes, or physician contact with the eye are needed.
And what does an imaging session look like?
The session itself takes 3 to 5 minutes for most patients—enabling integration into routine eye exams—and requires a pupil size of 2.5 mm.
- Note: Per technical specifications, the non-mydriatic minimal pupil size is 3.5 mm.
At the end of the session: A report is generated for a clinician to review.
That’s it?
Yup, that’s it.
Any other technical specifications to know about?
Oh, lots more. A few for your perusal:
- Light sources: white light-emitting diode (LED; 450 - 40 nanometers [nm]) and IR LED (825-870 nm)
- Imaging modalities: IR and MitoPhor
- Automatic operation: auto-alignment, focus, exposure, and capture.
- Auto-focusing adjustment range: -12D to +15D; 60 pixel/deg
- Optical resolution on the retina: 17 microns (μm)
See here for the complete list.
Alrighty, now to a critical question: Has it undergone clinical evaluation?
An extensive collection of research supporting the use of functional imaging (FPF; the foundation of the OcuMet Beacon) of the mitochondria can be viewed here.
Among the findings: As investigators from one 2020 clinical study determined, functional imaging can be viewed as a promising tool for retinal disease evaluation—including DR and AMD.
- “Whereas most current imaging modalities evaluate anatomic features, mitochondrial imaging distinguishes itself as a way to assess metabolic health of the retina,” they wrote.
And in 2023 research, investigators found a significantly increased intensity and heterogeneity of FPF to be correlated with such retinal diseases as geographic atrophy (GA) and neovascular (wet) AMD.
So! Where can I see the OcuMet Beacon for myself?
If you’re attending the 2025 Association for Research in Vision in Ophthalmology (ARVO) annual meeting next week (May 4-8), in Salt Lake City, Utah—you’re in luck!
- OcuSciences will be debuting the FDA-cleared technology at its booth (#1338). Stop by for a demo and check out the plethora of new supporting research being presented.
If not, stay tuned! The company reported it is currently in the discussion phase with eyecare providers to add the OcuMet Beacon to clinical practices around the country.