Ciliatech Opens U.S. Subsidiary to Expand its Clinical Research

French firm Ciliatech has opened a subsidiary in New York, which will serve as the central base for all U.S.-based clinical research and regulatory submission operations for the company’s glaucoma device, Intercil Uveal Spacer.
 
The leading cause of irreversible blindness, glaucoma affects roughly 4.22 million U.S. residents and has a global prevalence of 80 million. Of that total, 60 million are affected by primary open-angle glaucoma, the most common form.
 
As the world’s largest and most influential healthcare market, the United States is a strategic priority in Ciliatech’s growth. Having recently acquired CE certification of its Intercil Uveal Spacer, conducted three clinical trials, with a fourth underway in Europe, and enlarged its scientific expertise as well as medical and commercial teams, Ciliatech envisions a €25 million ($29.3 million) budget to support this U.S. initiative over the next five years. The main objectives are to manage the regulatory process, conduct local clinical trials, and leverage specific compliance expertise.
 
“The establishment of a US subsidiary demonstrates our confidence in the transformative benefits that our novel eye implant, Intercil, will bring to glaucoma patients in the U.S. and worldwide. Our newly created U.S. footprint is a significant step forward in Ciliatech’s journey in setting new standards in the field and in our ambition to become a global leader in glaucoma surgery,” Ciliatech Co-Founder/CEO Olivier Benoit said. “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.”
 
A key aspect of Ciliatech’s strategy is engaging with the ophthalmic surgery community and the U.S. Food and Drug Administration (FDA) to tailor its future clinical trials for the Intercil eye implant to meeting U.S. glaucoma patients’ needs and expectations. Pending Ciliatech’s FDA approval plans, the company anticipates initiating clinical studies before the end of 2026.
 
Intercil is the first in a new class of glaucoma surgical devices. It is implanted using a bespoke ab-externo surgical technique which preserves the eye’s anterior chamber. Intercil is positioned in the supraciliary space only, without artificial egress or opening to the anterior chamber (no cleft). It helps drain the aqueous humour out of the eye more effectively, naturally enhancing the uveoscleral outflow, without creating a small ‘bubble-like’ structure (bleb) on the eye’s surface. The device has exhibited a significant effect on lowering intraocular pressure and reducing the need for pharmacological treatments for up to three years.
 
“Together with an excellent safety profile and an intuitive surgical technique, Intercil offers an unrivaled benefit-risk ratio while addressing the critical needs of glaucoma patients and surgeons alike. Ciliatech is keen to bring this advanced glaucoma treatment to patients in the U.S.,” Benoit added.
 
Ciliatech is a medtech company focusing on glaucoma treatment. Following CE Mark approval, its Intercil Uveal Spacer, an implant in the new ‘Cilioscleral interpositioning Device’ (CID) category, is the first proprietary glaucoma device that treats both the open and narrow angle forms of the disease. Clinical trial follow-up of patients implanted with the device has now reached the three-year mark; demonstrating highly positive results in robust IOP-lowering coupled with a high safety profile. Multiple clinical trials of the second-generation Intercil are in progress. Intercil’s unique design facilitates external placement into the supraciliary space of the eye, without the device ever entering the eye’s anterior chamber, setting it apart from other standalone surgical glaucoma procedures.

Co-founded in 2017 by ophthalmic surgeon and inventor Dr. Philippe Sourdille, and Benoit, a veteran engineer and biotech entrepreneur, Ciliatech has to date raised €12 million ($14 million) and is continuing to expand its scientific, medical and commercial team. The company is headquartered near Annecy, France.