Medical technology (medtech) company Ciliatech has opened a new subsidiary location in the United States to support ongoing clinical research and advancement of its investigational novel glaucoma device.
Let’s first start with the company.
Headquartered in Chavanod, France, Ciliatech was founded in 2017 as an ophthalmic medtech company with a core focus on glaucoma treatment.
And how is it doing this?
That’s where its flagship glaucoma device comes in: the Intercil Uveal Spacer, which—though it’s recently received CE certification in the European Union—is currently still an investigational device in the United States.
But before we talk about that… first up is this new U.S. location.
So where are these new headquarters?
New York.
Its purpose: To serve as the “central base for all of Ciliatech’s clinical research and regulatory submission operations” for the Intercil.
As for why this U.S. expansion: As the company noted, the country is the “largest and most influential healthcare market in the world” and a strategic priority in Ciliatech’s growth.
And the intent?
Per Cilatech, the plan is to launch a U.S.-based initiative (with a $29.3 million budget over a 5-year period) that will support the following activities:
- Regulatory process management
- Conduct of local clinical trials
- Tailoring future studies of the Intercil to meet the needs and expectations of U.S. glaucoma patient care
- Leverage of specific compliance expertise
- Includes engaging with the ophthalmic surgery community and FDA
“In addition to facilitating regulatory approval, our subsidiary will also lay the groundwork for future commercial activities, including sales and marketing, as Intercil progresses towards FDA approval,” stated Olivier Benoit, Ciliatech’s CEO and co-founder.
Nice! Now let’s get the rundown on this device.
To start: The Intercil Uveal Spacer is a cilioscleral interpositioning device (CID) that reestablishes the natural uveoscleral outflow.
Specifically: This novel glaucoma implant is designed for sub-scleral placement with a bespoke ab-externo surgical technique to significantly lower intraocular pressure (IOP) in primary open-angle glaucoma (POAG) patients.
- Check out the list of contraindications based on its CE certification.
And how does it do this?
Via placement in between the ciliary body and sclera—all without:
- Needing to open the anterior chamber or create a cyclodialysis cleft.
- Alteration of the eye’s anterior segment
- Risk for corneal endothelial cell loss
See how this method compares to standard glaucoma surgical techniques (as well as the various benefits associated with it).
Tell me more about the implant’s design.
The Intercil is non-resorbable and constructed as a one-piece 26% hydrophilic acrylic implant (this material is often used in manufacturing intra-ocular lenses to guarantee long-term biocompatibility).
As for the implant itself:
- The device consists of a “precision engineered plate” trapezoidal in shape—and, notably, is not a tube, Ciliatech emphasized.
- Its design features grooves and corrugations to maximize outflow from the anterior chamber to the suprachoroidal space.
And the clinical research on it?
The SuprAciliary Filtration Alone Reduces IOP (SAFARI) clinical trial program has evaluated Entercil in three multicenter, prospective, nonrandomized trials:
- SAFARI 1 (NCT03736655)
- SAFARI 2 (NCT04770324)
- SAFARI 3 (details here)
The data: Extends out to 2-year and 3-year outcomes, with the implant demonstrating a significant IOP-lowering effect as well as a reduction (and complete elimination) in the need for medication following placement.
Can you get into specifics?
We’ll refer back to our September 2024 coverage of the 36-month findings from the SAFARI studies, which reported an IOP control of 8.0 mmHg as well as:
A mean pressure reduction of 33% versus baseline and 70% reduction in medication (prostaglandin treatment) dependence
- Even better: 68% of the 41 patients evaluated remained medication-free after 36 months.
See here for more numbers.
So! What do we know about the clinical trial plans in the U.S.?
With a potential FDA approval in mind (and providing the agency gives the OK for its trial plans), Ciliatech expects clinical trials on the Intercil to kick off before the end of 2026.