Ciliatech has received US Food and Drug Administration (FDA) approval of an investigational device exemption (IDE) application allowing the company to begin a US feasibility study of the Intercil Uveal Spacer in patients with primary open-angle glaucoma (POAG).

The study is expected to enroll approximately 30 patients at 3 clinical sites in the United States and will evaluate the safety and performance of the glaucoma implant. Results will help inform subsequent stages of the company’s US clinical and regulatory program.

The Intercil Uveal Spacer (Figure 1) is a flat, trapezoidal implant made of hydrophilic acrylic material. Implanted through an ab externo approach, the device is designed to create controlled supraciliary spacing and facilitate uveoscleral outflow without entering the anterior chamber or creating a subconjunctival bleb.

The device has previously been evaluated in Ciliatech’s SAFARI clinical program in Europe, which provided clinical data supporting the IDE application. Intercil is CE-marked and in the precommercial phase in Europe. GP