Sensimed has announced the registration of the Sensimed Triggerfish sensor and monitoring system as a medical device in Japan.
The Japanese partner and distributor of Sensimed, SEED Co., has obtained the approval from the Ministry of Health, Labour and Welfare. The device will be available for sale toward the end of 2018.
Sensimed, a Swiss company, has developed a unique noninvasive soft contact lens-based solution, the Sensimed Triggerfish, which provides an automated recording of continuous ocular dimensional change over 24 hours. The product received the CE mark in 2010 and was approved by the FDA in 2016.
The contact lens sensor itself is very well tolerated over the measurement period and uses telemetry in combination with a fully integrated sensor to measure volumetric change of the eye. To date, Sensimed has published over 40 peer review articles in respected ophthalmic journals to support these conclusions. This completely new measurement is highly correlated with IOP change and has been shown to be lined to previous rate of progression data.
Sensimed continues its close collaboration with SEED who have a very strong organization to support the launch of this first of a kind smart contact lens in the Japanese market. Besides preparing for the establishment of a sales structure for the Japanese market, the two companies intend to quickly accumulate clinical data from specialized medical centers focused on confirming 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 large unmet need for an alternate 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 it can significantly reduce the burden of night time IOP measurements while at the same-time help with the categorization of NTG patients,” David Bailey, CEO of Sensimed, said in a company news release.
In gaining the 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.