Key Takeaways

  • FDA approval of Ciliatech’s IDE allows the company to begin a US feasibility study of the Intercil Uveal Spacer in approximately 30 patients with POAG at 3 clinical sites
  • The ab externo implant is designed to support uveoscleral outflow through controlled supraciliary spacing without entering the anterior chamber or creating a subconjunctival bleb
  • Ciliatech is evaluating Intercil for patients who may require more intervention than conventional MIGS but may not yet be candidates for filtering surgery

Ciliatech has received FDA approval of its Investigational Device Exemption (IDE) application to begin a US feasibility study of the Intercil Uveal Spacer in patients with primary open-angle glaucoma (POAG).

Ciliatech plans to enroll about 30 patients across 3 US clinical sites. The study will assess the safety and performance of the investigational glaucoma implant, with findings expected to inform subsequent stages of Ciliatech’s US clinical and regulatory development program.

“FDA approval of our IDE application is an important milestone in the US development of Intercil,” Olivier Benoit, CEO of Ciliatech, said in a news release. “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.”

Intercil is a flat, trapezoidal implant made from hydrophilic acrylic material. Implanted using an ab externo surgical approach, the device is designed to create controlled spacing in the supraciliary space to support uveoscleral outflow. The approach does not enter the anterior chamber or create a subconjunctival bleb.

Ciliatech is positioning the device for what it describes as the “middle segment” of the glaucoma treatment pathway—patients whose disease may require an intervention beyond conventional minimally invasive glaucoma surgery (MIGS) but for whom filtering surgery may not yet be appropriate.

“The middle segment represents an important clinical decision point in the glaucoma treatment pathway,” Mark Packer, MD, chief medical officer, US, at Ciliatech, said in the release. “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 has previously been studied in Europe through Ciliatech’s SAFARI clinical program. According to the company, data from that program supported its IDE submission and provided clinical experience to help inform the design of the US feasibility study.

Intercil is CE-marked and is in the pre-commercial phase in Europe. In the United States, the device remains investigational and is not approved for commercial sale. The IDE approval permits Ciliatech to use the device in the specified clinical investigation under applicable FDA requirements.