Implandata Completes Enrollment in ARGOS-SC01 Clinical Study

Ophthalmic medical device company Implandata Ophthalmic Products GmbH (Implandata) announced that study enrollment of its international ARGOS-SC01 clinical study was completed with the inclusion of the 24th study patient. This first-in-human clinical study is conducted to validate the suprachoroidally placed EYEMATE-SC sensor implant for continual monitoring of intraocular pressure (IOP). Lead investigator Prof. Dr. med. Peter Szurman from Eye Sulzbach at Knappschaft Hospital Saar, Germany said: “The sensor is small and easy to implant, so most patients undergoing glaucoma surgery are eligible for such a pressure sensor. This enables glaucoma patients for the first time to monitor their own eye pressure at any time. It will improve the safety for glaucoma patients and significantly reduce the risk of blindness due to glaucoma.”
 
While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use at glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation at glaucoma patients not indicated for cataract surgery yet, thus complementing Implandata’s product offering and expanding the indication of use of the EYEMATE-system.
 
Prof. Dr. med Kaweh Mansouri, consultant ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland and CMO of Implandata commented: “We are pleased to have completed enrolment of this important study and having excellent outcomes so far in all patients, some of them having had the SC sensor for more than a year. Both safety and performance of the device have exceeded our expectations and we are looking forward to the forthcoming interim results.”
 
Study centers of the ARGOS-SC01 clinical study are the Eye Sulzbach at Knappschaft Hospital Saar/Germany, the Ophthalmic Clinic of Ruhr-University Bochum/Germany, the Department of Ophthalmology at University Mainz/Germany the Eye Department of LMU Medical School Munich/Germany and Montchoisi Clinique Lausanne/Switzerland. The study is closely supervised by an independent Data Safety Monitoring Board, chaired by Prof. emeritus Günter Krieglstein, who was the former director of Department of Ophthalmology of Medical University Cologne/Germany and a worldwide renowned glaucoma expert.
 
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 and influenced by many parameter and thus changing throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP measurements throughout 24 hours and outside the ophthalmologists office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients. Robert N. Weinreb, M.D., chair and Distinguished Professor of Ophthalmology and director of the Shiley Eye Institute of University California – San Diego and chair of Implandata’s Scientific Advisory Board predicted that “Continual measurement of intraocular pressure via the EYEMATE system will transform and individualize the management of glaucoma. In addition, it will enable improved adherence with medication and provide deeper insight about glaucoma.”
 
As the EYEMATE system provides direct feedback to the patient in a home setting—information previously unavailable to the patient—therapy adherence is expected to be improved, as it was already observed in earlier studies. Additionally, EYEMATE’s remote patient care capabilities will result in more efficient disease management, as number of office visits may be reduced for a considerable number of patients, while the eye doctor attains more and better information about the patient’s specific situation.
 
Glaucoma is a chronic eye disease and the leading cause for irreversible vision loss worldwide. Intraocular pressure is the only modifiable risk factor to reduce the peril of vision loss. Reduction and control of eye pressure at glaucoma patients limits the risk of disease progression considerably.¹ Close to 80 million patients are affected by the disease globally; because of aging populations the number of patients is expected to increase to 112 million patients by 2040.² Thus, Implandata is addressing a pressing need in a further growing market with its products for improved glaucoma care.

References
¹ Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial; Heijl et al, 2002
² “Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040”; Tham et al, 2014