First ever glaucoma-sensing contact lens approved
The first ever contact lens to use digital technology to monitor for glaucoma has been approved by the FDA as a prescription device.
The ‘Triggerfish’ contact lens has been developed by Switzerland-based company Sensimed, which has been developing the technology for 13 years.
Embedded in the lens is a specially developed sensor which measures intra-ocular pressure (IOP) over a period of up to 24 hours. This could be a major step forward over current practices, where patients must visit their ophthalmologists to have a single IOP reading taken.
The data recorded by the lens are wirelessly transmitted to an adhesive patch around the eye which acts as an antenna. The data can then be downloaded through a cable to a portable reader, and then sent on to the doctor’s computer for analysis.
Sensimed announced the approval on 15 March, and says it is confident that Triggerfish can help doctors to detect this danger sign of glaucoma, which can lead to blindness if not treated.
“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”, said David Bailey, CEO of Sensimed.
“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.”
The company says it won’t launch the product immediately, but will instead pursue a major post-approval study to confirm that the device can accurately predict the course of progression of the disease.
Data produced by the device is already being analysed and modelled, with the aim of identifying disease patterns to differentiate between different disease types, personalise treatment and assess how effective treatment has been.
The company says the FDA clearance is a ‘pivotal platform approval’ that will allow it to explore other potential applications for its groundbreaking technology.
This could mean a future link up with pharma companies or health data firms.
Sensimed has stolen a march on a rival partnership between Novartis and tech giants Google. The Swiss pharma giant and Google have being working on a similar smart lens to monitor glucose levels in diabetes patients, and expect it to enter clinical trials this year.
Novartis recently revealed that its Alcon ophthalmology division is also working on corrective eyewear. This includes a contact lens that would restore the ‘autofocus’ powers in patients with eye conditions which are hard to treat with traditional lenses.
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