EyeTechCare Focused Ultrasound Treatment Device Gains CE Mark Extension
News Feb 06, 2015
EyeTechCare SA has announced that it has received CE mark extension to new indications for its focused ultrasound glaucoma treatment. The medical procedure will now address all patients living with uncontrolled glaucoma irrespective of their prior treatment history. This innovative and non-invasive therapy reduces intraocular pressure by utilizing proprietary focused ultrasound technology.
It benefits from a very good safety profile and offers a predictable, trouble-free patient follow-up.
Clinical trials for the EyeOP1 device commenced in 2010 (Pilot Study, EyeMUST 1 & 2 studies) and have resulted in excellent outcomes in terms of both tolerance and efficacy. These results compelled the investigators to push for a broader application for this treatment.
The aim was to include patients with moderate-stage glaucoma who have not yet undergone surgery. As a result, the company launched the EyeMUST 3 clinical investigation. After 12 months of follow-up, the results of this new trial involving 30 patients proved successful in individuals with uncontrolled glaucoma under hypotensive medical treatment.
“We are very pleased to expand the indications of our device,” said Dietrich Wolf, CEO of EyeTechCare. “This marks an important milestone in the development of our company, especially from a clinical standpoint. From now on, the treatment can be offered to a far greater number of patients. We are convinced that this new therapeutic procedure will soon play a key role in the management of glaucoma patients who are often apprehensive about having surgery.”