Implandata Launches Pre-Clinical Studies for Implantable Extraocular Sensor

Implandata Ophthalmic Products GmbH (Implandata) and Professor Peter Szurman, head of Section Experimental Ophthalmic Surgery at the University Eye Hospital in Tübingen, Germany, have started pre-clinical studies for the first implantable, permanent extraocular sensor measuring intraocular pressure. The primary objective of the study is to show proof of concept and to demonstrate product and procedure safety. It is expected that the studies will provide additional design input before human trials begin.

While the company’s permanent intraocular pressure sensor is implanted in patients with pseudophakic eyes (glaucoma patients who undergo cataract surgery, or where cataract extraction has been done already before), the less invasive extraocular sensor implant measuring intraocular pressure also can address glaucoma patients with phakic eyes with healthy intraocular lenses.

The micro sensor of both versions allows close monitoring of the patient’s disease status and glaucoma therapy success, the company said in a news release. Through simple and more frequent measurements of intraocular pressure – which is the key parameter in glaucoma therapy – important information on therapy response is delivered to the ophthalmologists early on, enabling immediate glaucoma management adjustment, resulting in prevention of further vision loss due to uncontrolled intraocular pressure. Patients can perform pressure measurements with ease by themselves at home and under normal life conditions, bigwigs noted.

“The implantable micro sensor will provide a new dimension in glaucoma monitoring, management and control,” Szurman said. “This device is the next step to personalized glaucoma therapy and will be an effective tool to monitor intraocular pressure even out of medical practice hours and thus help us preventing progression of intraocular pressure-associated optic neuropathy which would further lead to permanent vision damage and blindness.”

After being implanted through a minimally invasive procedure, the extraocular micro sensor is easy to handle for the health personnel and the patient and is a reliable way to measure intraocular pressure with high precision, Szurman said.

After successfully completing the ARGOS-01 early feasibility study, Implandata currently is conducting ARGOS-02 clinical study with its implantable intraocular pressure sensor, with the goal to start the EC Conformity Declaration process in 2015. After finishing the pre-clinical study with the implantable extraocular sensor measuring intraocular pressure by end of 2014, Implandata and Szurman will decide on next steps towards early feasibility studies of the extraocular placed sensor at glaucoma patients.

Implandata Ophthalmic Products GmbH is a privately held medical device developer of glaucoma-related products founded in 2010 and headquartered in Hannover, Germany.