CE Mark Granted for Intercil Uveal Spacer Eye Implant

Ciliatech has earned CE mark certification for the Intercil Uveal Spacer, a key product in a new kind of glaucoma surgical procedure. The device currently is registered in the United Kingdom.
 
The Intercil Cilioscleral Interpositioning Device (CID) is designed to lower intraocular pressure (IOP) by increasing uveoscleral outflow without penetrating the eye’s anterior chamber. This approach may preserve the integrity of the eye’s anterior chamber using a “no-bleb-no-cleft” approach, offering potential benefits in minimizing corneal endothelial cell loss risk. This surgical technique transforms the way surgeons approach the eye’s supraciliary space and demonstrates a high safety profile, minimizing complications and providing a comfortable post-operative recovery for patients, according to Ciliatech.
 
The CE mark approval validates that Intercil meets the EU MDR’s stringent requirements. Besides obtaining the CE mark, Ciliatech secured funding, boosting European sales development and a U.S. strategy rollout.
 
“Ciliatech is thrilled to obtain CE certification for our Intercil Uveal Spacer under the scope of MDR. This critical step is the culmination of years of hard work and significant investment,” Ciliatech CEO Olivier Benoit said. “In our steadfast commitment to offering a genuine solution to patients who endure the impacts of glaucoma and thanks to new funding, we can now accelerate the commercial availability of Intercil, roll out its distribution in select European countries and plan for future registrations in key markets, notably the U.S. and China. We anticipate that glaucoma surgeons and early adopters of innovation will see the value in our ‘no-bleb-no-cleft’ approach in achieving robust IOP lowering with minimal post-op care.”
 
The leading cause of irreversible blindness, glaucoma affects 80 million people worldwide; that total is expected to increase to 111.8 million by 2040. Intercil represents a new paradigm shift in standalone glaucoma surgery.

Traditional options typically create a bleb, which carries the risk of infection and demands an intense post-operative follow-up schedule for patients. Other surgical options may be conservative in their ability to reduce IOP due to natural physiological limitations of the eye’s conventional outflow pathways. Intercil’s surgical approach may overcome these drawbacks.
 
Glaucoma is a progressive disease that requires effective management at all stages. While existing treatments such as selective laser trabeculoplasty (SLT) and angle surgery may be suitable for mild cases, and bleb-forming/filtering procedures are reserved for severe cases, patients with moderate glaucoma often remain underserved.
 
“Intercil addresses the underserved need in treating moderate glaucoma. It bridges the gap between techniques for mild cases and filtering surgeries, providing surgeons with further options to manage disease progression. The device’s compatibility with narrow-angle cases further broadens its potential applicability, making it a versatile choice for diverse clinical needs across multiple patient populations,” Benoit stated.
 
Key features of Intercil:

• Anterior Chamber-free: Utilizes the supraciliary space and increases uveoscleral outflow without anterior chamber cleft, potentially minimizing related complications
• Robust IOP lowering: Effective standalone treatment for Primary Open-Angle Glaucoma (POAG) and Primary Angle-Closure Glaucoma (PACG) without the need for a bleb or antimetabolites
• Versatile positioning: Can be positioned 360° around the eye, ensuring optimal placement
• Broad applicability: Suitable for narrow-angle glaucoma patients, addressing a critical gap in current treatment options

Ciliatech is a medtech company focusing on glaucoma treatment. Its Intercil Uveal Spacer, an implant in the new Cilioscleral interpositioning Device category, is the first proprietary glaucoma device that treats both the disease’s open and narrow angle forms. 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 Intercil’s second-generation are in progress. Co-founded in 2017 by ophthalmic surgeon and inventor Dr. Philippe Sourdille and Olivier 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 located near Annecy, France.