You literally cannot see glaucoma coming.
Although it’s one of the leading causes of blindness in the world, frighteningly little is known about a disease group that affects 4 percent of the world’s population over the age of 40. No cure is on the horizon. And due to the insidious nature of the disease, which stars gradually affecting sight from the periphery, most people don’t even know they’re suffering from glaucoma until it’s too late.
Swiss diagnostics company Sensimed AG sees this mysterious disease as a real opportunity.
Representatives from the firm, in Boston last week for the World Glaucoma Congress, say the company is developing a new type of contact lens-based diagnostic tool, designed to generate more accurate blueprints for the treatment of glaucoma. Current clinical solutions are dominated by large pharma companies like Pfizer and Allergan (which made news in January when it repackaged its Lumigan eye drops for glaucoma into Latisse, an FDA-approved treatment to help grow thicker eyelashes).
Unlike the several companies developing contact lenses as a platform for drug delivery, Sensimed’s idea is to use them as a platform for diagnostics.
The company’s first product, the Sensimed Triggerfish, uses micro-electro-mechanical systems technology embedded in a regular-sized soft contact lens. When connected to a loop-antenna and a micro-processor with an analog/digital telemetric system, it takes 24-hour, continuous measurements of the eye. It’s designed to allow patients to sleep in their own homes, rather than dossing down in a sleep lab, with an eye toward beginning to provide some answers to this mysterious disease.
MassDevice spoke with Sensimed CEO Jean-Marc Wismer about the technology, its upcoming date with the FDA and a possible U.S. headquarters in Boston.
MassDevice: What is the standard of care for glaucoma patients and how does Sensimed fit into that?
Jean-Marc Wismer: We’re a little agnostic about the standard of care. We want to provide more visibility about how patients are treated. We hope to provide a better management of the treatment process. But we know that one in three patients has inadequate treatment for the disease. So no matter if its drugs or surgery the patient will keep losing their vision unless we know more about the disease and the appropriate treatment.
MassDevice: What are the current testing methods for glaucoma?
JMW: The eye is a breathing machine. It produces and evacuates fluids, which is what maintains the eyeball’s intra-ocular pressure. The balance of producing and evacuating fluids is what maintains a healthy amount of intra-ocular pressure. With glaucoma, that balance is disrupted. However, it’s not constantly broken. It moves in cycles.
There are many differences in intra-ocular pressure — for example, intra-ocular pressure peaks at night. The high peaks are detrimental to the optic nerve. But these peaks are not random; they move in cycles. But there are great individual differences that are difficult to detect. There is little that is understood about the eye, so there are lots of question marks.
Currently the only thing available to track this is having the patient go to a sleep lab, where they take a series of snapshots. But there are limitations to this. First, it’s annoying for the patient and it’s very expensive. Further, the setting will bias the results, because you have to wake the patient up to take the measurements, which will change the intraocular pressure.
MassDevice: Your product looks like a normal contact lens with what looks like a microchip in it. How does it work?
{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Wismer_JeanMarc_100x100.jpg}JMW: It is a regular contact lens with a microchip, which is 50 microns thick. It’s very small; if you stacked 20 on top of each other it would be about one millimeter thick. There’s a strain gauge, which is a thin wire that goes over the eye. As the eye expands it stretches the lens to measure the cornea. Then the gold ring is a MEMS micro antennae which sends a signal to the flexible antennae that sends an electromagnetic pulse that sends the signals back to a data recorder. After 24 hours you take it back to the optometrist.
MassDevice: How was the technology created and when was the company founded?
JMW: Our founder, Matteo Leonardi, was a student at the Swiss Federal Institute of Technology. It was a result of listening to a meeting between bio-engineers and doctors who were voicing their unmet needs about 10 years ago. The company was a result of his thesis. It was created as a legal entity in 2003 and started operations in 2007. [Editors note: click here to see a video with Leonardi on about the development of the Sensimed.]
MassDevice: How did you come on board and how is the company funded?
JMW: We have raised $8 million [Swiss francs] from Wellington Ventures and Vinci Capital. I got involved in 2007 when I helped the company get funded and the investors asked me to stay on. I’m a Medtronic vet and I was active in the field of coaching startups to get financing. There’s a sense of mission here that is very appealing.
MassDevice: Where are you with the various regulatory agencies, and what brings you here to Boston?
JMW: We have the CE mark, which we received in February. We’re currently working on application trials to explore the best opportunity where the value is greatest. We’re a new tool on the market, so we have to turn to the professionals now to tell us how this is best used and to broaden its commercial appeal. We’re also applying for FDA approval later in the summer. We’re here in Boston because we’re also looking for a U.S. base of operations, which will most likely be in Boston.
MassDevice: What do you think the price point will be for the product? What do you think the total market is for a product like this?
JMW: It’s too soon to determine pricing. We’re still waiting for the trials to be completed and we’ll determine pricing later in the year.
They predict that there about 60 million people in the world suffering from glaucoma, with up to 100 million people being affected in the next 10 years. For us the environment is big.There is a desperate, highly motivated population of people who are losing their eyesight.
MassDevice: What will your sales approach be,and how will you get over the reimbursement hurdle?
JMW: The speed of adoption is unknown at this point. Our reimbursement picture is that we’re a new technology.
We’re looking at a specialized access to the market. We will probably be for the home care prescription market; we’re not targeting optometrists on the street. We’ve segmented the United States into entry points of California, Texas, Florida and most of the East Coast, which is where 50 percent of the population of people suffering from glaucoma live.
We don’t want to build our own distribution channels. We’re looking for partners.
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