Switzerland-based Sensimed announced it received a de novo FDA clearance for its connected contact lens, Triggerfish, which helps physicians track the progression of glaucoma in patients.
“Although with this approval we have obtained US marketing clearance, our goal for the upcoming months is not to immediately launch the product but rather to work closely with the glaucoma community to design and execute a major post-approval study to confirm the use of the Sensimed Triggerfish signal to predict the course of progression of the disease,” Sensimed CEO David Bailey said in a statement. “The overall aim is to build additional clinical utility for the device and establish ocular volume change patterns as a significant stand-alone reference biomarker for use in the management and treatment of glaucoma.”
Triggerfish is a sensor-embedded contact lens that will record continuous ocular dimensional changes for 24 hours. The data is sent from the lens wirelessly to a recorder that users wear around their neck. After the recording period has ended, the data is transferred from the recorder to a physician’s computer via Bluetooth -- meaning the patient needs to return to the physician's office to upload it.
Sensimed’s Triggerfish is a prescription device indicated for people 22 or older to detect the peak patterns of variation in intraocular pressure to identify the window of time to measure intraocular pressure by conventional clinical methods.
“We are delighted to have worked closely with FDA on this de novo application and to have gained approval for this first-of-a-kind contact lens-based sensing device in the USA”, Bailey said. “There is a very strong interest within the ophthalmic community for the whole concept of contact-lens based sensing and we are extremely proud to have created and developed the first ever product approved in this category.”
Triggerfish is classified in a new category, called diurnal pattern recorder system, which is defined as “a non-implantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations”.
Companies and research organizations have been working on connected contact lens projects for a number of years now.
In 2008, a team from the University of California Davis developed a contact lens made up of a material called polydimethylsiloxane (PDMS), which was strategically layered with powdered silver to create conductive wires. In the shape of a contact lens, this device could be used to measure pressure in the eye, which researchers said could lead to glaucoma and potentially blindness.
Then in early 2014, a more high profile contact lens project, led by Google, was announced to develop a noninvasive method of measuring blood glucose levels in people with diabetes. Seven months after this announcement, Google partnered with Novartis eye care division Alcon to license its still-largely-theoretical "smart lens" to the Swiss pharma company.
And last year, Thiel Foundation announced that Harry Gandhi, cofounder and CEO of digital health startup Medella Health was a 2015 Thiel Fellow. Medella Health is developing glucose-sensing contact lenses.Nike Paul George PG3