Eye Tech Care Begins Approval Process for Glaucoma Treatment Device in China

Rillieux-La-Pape, France-based Eye Tech Care SA, which makes equipment for non-invasive medical treatment in ophthalmology, has begun the approval process in China for EyeOP1, its system for glaucoma treatment. The system has already received Medical Device classification from the China Food and Drug Administration (CFDA).

EyeOP1 is on the market in Europe and the United States, and according to the company, China represents a key market for expansion. Twenty two million people suffer from glaucoma in the country, representing 28 people of people involved with the pathology worldwide. Many of these people have advanced glaucomas, requiring surgery, which may later result in complications linked to the complexity of the surgery’s procedure and conditions since the latter needs to be carried out in specialist care units by surgeons who have received special training.

EyeOP1 is meant to offer an alternative to surgery. It is intended for all patients suffering from uncontrolled glaucoma, irrespective of prior treatment, and perfectly meets the needs of the Chinese market. An outpatient procedure, the treatment produces a significant reduction in intraocular pressure. Based on the principle of a plasty, or surgical treatment, of the ciliary body by ultrasound, it produces a partial, gentle and precise coagulation of this area of the eye to reduce production of aqueous humor.

“The reception for our EyeOP1 system from the heads of ophthalmology services in major Chinese hospitals has been very encouraging,” said CEO Dietrich Wolf. “The number of patients and surgical interventions in China is remarkable. This environment is a promising one in our search for clinical expertise for future partnerships as part of the clinical trials required for approval.”

Eye Tech Care has drawn on a highly qualified network of experts and local consultants specializing in the approval process, clinical markets and commercial development in China.