The Lausanne based Sensimed has received approval for its Triggerfish sensor and monitoring system to be marketed as a medical device in Japan. The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume.
The Triggerfish sensor is a non-invasive soft contact lens-based solution designed to revolutionize glaucoma management by providing an automated recording of continuous ocular dimensional change over 24 hours. Glaucoma is an irreversible disease that leads to blindness unless adequate treatment is provided.
By providing ophthalmologists with the 24-hour profile of ocular dimensional changes related to intraocular pressure, the SENSIMED Triggerfish helps the doctor understand the condition of the patient and to provide personalized treatment.
In 2010, the product received the CE mark, and in 2016, it was approved by the U.S. Food and Drug Administration (FDA).
Sensimed's partner SEED, the Japanese based contact lens manufacturer, will lauch Triggerfish in the Japanese market towards the end of 2018. In preparation for the launch, the two companies intend to quickly accumulate clinical data from specialized medical centers focused on confirming the medical utility of the SENSIMED Triggerfish in the field of glaucoma.
The focus in Japan will be on the significant pool of patients who have normal tension glaucoma (NTG) where standard IOP measurement tools are inadequate and where there is a substantial unmet need for another diagnostic tool. The 24-hour profiles provided by the device, linked with the disease progression, will be analyzed and modeled in an attempt to confirm pathological patterns that can be used to categorize the disease state and aid personalized treatment.
“We believe that the solution can significantly reduce the burden of nighttime IOP measurements while at the same time help with the categorization of NTG patients”– stated David Bailey CEO of Sensimed.
Thanks to receipt of their market approval, both companies have received significant support from key opinion leaders representing the Japanese glaucoma society in working with PMDA to create this new category of smart contact lens. Both SEED and Sensimed will continue to actively collaborate in other areas of the sensing contact lens business – Sensimed is currently using the same technology platform as the SENSIMED Triggerfish to bring to market a pressure sensing contact lens measuring IOP in standard units over a 24-hour period. Initial clinical trials have been completed and the results clearly demonstrate success with this revolutionary noninvasive technology.
(Press release)
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