Ciliatech receives FDA IDE approval to initiate US feasibility study of INTERCIL

Ciliatech, a medical technology company developing surgical solutions for glaucoma, has announced FDA approval of the company’s Investigational Device Exemption (IDE) application to initiate a feasibility study in the US of the INTERCIL Uveal Spacer for glaucoma.

The study is expected to enroll approximately 30 patients at three US clinical sites and will evaluate the safety and performance of INTERCIL in patients with primary open-angle glaucoma (POAG). Results from the study will inform the next stages of Ciliatech’s US clinical and regulatory development program.

INTERCIL is a flat, trapezoidal glaucoma implant made of a hydrophilic acrylic material and placed through an ab externo surgical approach, meaning a procedure that is performed starting from the outside surface of an organ or tissue and working inward.

“FDA approval of our IDE application is an important milestone in the US development of INTERCIL,” said Olivier Benoit, CEO of Ciliatech. “It allows us to begin generating US clinical evidence and advance a development program focused on an important unmet need in the glaucoma treatment pathway. We are pleased to begin this next phase of clinical development with our American investigators.”

The US feasibility study is not the first-in-human evaluation of INTERCIL. The glaucoma implant has previously been evaluated in Ciliatech’s SAFARI clinical program in Europe. Data from that program supported the company’s IDE submission and provides prior clinical experience to inform this study according to the company.

Ciliatech describes its development focus as the ‘middle segment’ of the glaucoma treatment pathway: patients who need more than conventional MIGS (Minimally Invasive Glaucoma Surgery) but for whom filtering surgery may not yet be appropriate. INTERCIL is being evaluated as a potential non-bleb surgical approach to address the unmet need within this patient segment.

“The middle segment represents an important clinical decision point in the glaucoma treatment pathway,” said Mark Packer, MD, chief medical officer, US, Ciliatech. “This feasibility study will provide important US clinical experience with INTERCIL and help us better understand the potential role of a supraciliary, non-bleb approach for these patients.”
 
INTERCIL is CE-marked and is currently in the pre-commercial phase in Europe. In the United States, INTERCIL is an investigational device and is not approved for commercial sale. IDE approval authorises use of the device in the specified clinical investigation under applicable FDA requirements.