Implandata Ophthalmic Products announced that the first patient in its international, multi-center, ARGOS-SC01 clinical study has been successfully implanted with its novel pressure sensor. This first-in-human clinical study is being conducted to validate the suprachoroidally placed Eyemate-SC, a sensor implant for continual monitoring of intraocular pressure (IOP).
While Implandata’s already CE-marked Eyemate-IO intraocular sensor implant is intended for use in glaucoma patients undergoing cataract surgery, the Eyemate-SC device allows implantation in glaucoma patients not indicated for cataract surgery yet, according to the Hanover, Germany company.
“The new Implandata sensor is pleasantly small and easy to surgically implant; therefore, most patients undergoing glaucoma surgery are likely to be eligible candidates for such a pressure sensor,” said principal investigator Peter Szurman in a prepared statement. Szurman performed the implantation of the Eyemate-SC device in conjunction with non-penetrating glaucoma surgery at the Eye Clinic Sulzbach of Knappschaft Hospital Saar, in Sulzbach, Germany.
“This breakthrough product enables glaucoma patients for the first time to monitor their own eye pressure at any point in time,” Szurman added. “I expect that it will improve therapeutic compliance and also significantly reduce the risk of unnecessary visual field loss or even blindness due to glaucoma.”
Intraocular pressure monitoring is a considerable challenge for glaucoma patients and their ophthalmologists. Current IOP measurement methods require in-office procedures to be performed by trained medical staff. However, these measurements are obtained just a few times a year, although it is known that the eye pressure is highly dynamic, influenced by many parameters and changes throughout the day.
The Eyemate system provides actionable, continuous IOP measurements outside the ophthalmologist’s office, enhancing treatment options and contributing to less vision loss in glaucoma patients, according to the company. Earlier studies demonstrated that the Eyemate system, which provides direct feedback to the patient in a home setting, improves therapy compliance. It may also reduce the number of office visits and provide the ophthalmologist’s with more and better information about the patient’s specific situation, according to Implandata.
Lastly, the aggregation of IOP measurement data may shed new light on the emergence and progression patterns of the disease, potentially unlocking new or more efficacious intervention approaches, the company added.
“The successful inclusion of the first Argos-SC01 study patient is a pivotal milestone for Implandata towards broadening the use of our Eyemate system, eventually allowing also stand-alone implantation of our proprietary eye pressure sensing devices,” said Implandata CEO Max Ostermeier.
Implandata is expanding the study to other sites in Germany and Switzerland and expects it to be completed by early 2020.