Ciliatech has received FDA clearance for an investigational device exemption (IDE) application to initiate a U.S.-based clinical study of its flagship glaucoma device.
First up: a refresh on Ciliatech.
Operating out of Chavanod, France, the ophthalmic medical technology (medtech) company’s core focus is on developing that aforementioned novel glaucoma device: the Intercil Uveal Spacer.
Tell me about this.
The Intercil Uveal Spacer is a cilioscleral interpositioning device (CID) designed for sub-scleral placement via a bespoke ab-externo surgical technique.
- Its purpose: to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) by reestablishing natural uveoscleral outflow.
How it works: The implant is placed between the ciliary body and sclera—all without opening the anterior chamber, creating a cyclodialysis cleft, altering the eye's anterior segment, or risking corneal endothelial cell loss.
See how this method compares to standard glaucoma surgical techniques, along with its associated benefits.
Talk about its design.
Intercil is a non-resorbable, one-piece, 26% hydrophilic acrylic implant—a material widely used in intraocular lens (IOL) manufacturing to ensure long-term biocompatibility (or "uveocompatibility").
The device consists of a trapezoidal "precision engineered plate" measuring 7mm x 3.4mm x 0.6mm—not a tube, Ciliatech emphasized—and featuring grooves and corrugations to maximize outflow from the anterior chamber to the suprachoroidal space.
- Review the contraindications listed under its CE certification.
CE certification? Does that mean it’s already cleared for commercial use?
Outside of the United States? Yes. The device was granted CE certification in August 2025 as a new class of surgical implant “under the scope of medical regulation.”
And in addition to its CE mark, Intercil is reportedly “currently in the pre-commercial phase in Europe.”
Duly noted. Now circle back to its U.S.-related progress.
This U.S. feasibility study is expected to enroll an estimated 30 participants at three U.S. clinical sites, according to Ciliatech.
- Its purpose: to evaluate INTERCIL’s safety and performance when used in this patient base.
- The intent: for the study’s results to inform the next steps in the device's U.S. clinical and regulatory development program.
And do we have a timeframe for its initiation?
Not so far …
How about prior clinical data on the device?
That we do have, as we previously reported on INTERCIL’s performance in the European-conducted SupraAciliary Filtration Alone Reduces IOP (SAFARI) clinical trial program.
The dataset to focus on: positive findings from the SAFARA 1 and 2 first-in-human (FIH) studies evaluating a combined total of 49 POAG patients.
And those numbers?
See here for 12-month follow-up data, in which the implant—in conjunction with pharmacological treatments—demonstrated “strong potential” to drastically reduce IOP without entering the eye’s chamber.
Also check out the 24-month follow-up, in which a stable IOP over time (within a safe zone range of 15 mmHg) was demonstrated as well as:
- 95% of patients below 21 mmHg
- 81% of patients below 18 mmHg
- 90% of patients prostaglandin medication-free
Anything beyond that?
Yes! Click here for our coverage on the positive 36-month follow-up data based on results from 41 patients between the two SAFARI trials.
- Sneak peek: Ciliatech reported an IOP control of 8 mmHg.
Anything else worth discussing?
Just one more piece of information regarding the company’s plans for this upcoming U.S. feasibility study: While not mentioned in this latest IDE study news, Ciliatech shared plans last year to open a U.S. subsidiary in New York.
Its purpose, as we reported: to serve as the “central base for all of Ciliatech’s clinical research and regulatory submission operations” in the United States for the CID implant.
Check out the full details of this U.S.-based initiative.