Ciliatech to Present 36-Month Follow-Up Results on Intercil Uveal Spacer at Ophthalmology Futures European Forum
Ciliatech has announced that it will reveal the combined 36-month follow-up results of its SAFARI I & II clinical trials at the Ophthalmology Futures European Forum on September 5. The company will share data on its Intercil Uveal Spacer, a Cilioscleral Interpositioning Device (CID) designed to treat primary open-angle glaucoma (POAG).
The Ophthalmology Futures European Forum brings together experts from various fields, including clinicians, scientists, regulators, and business leaders, to explore cutting-edge developments in ophthalmology. Ciliatech’s presentation will focus on the 3-year efficacy and safety outcomes of its CID implant in 41 patients who underwent the procedure to manage IOP.
Promising Clinical Outcomes
The 36-month results demonstrate sustained IOP control, with an average reduction of 8.0 mmHg, equating to a 33% decrease from baseline. Additionally, 70% of the patients experienced reduced dependence on glaucoma medication, with 68% of the participants remaining medication-free over the entire follow-up period. Importantly, there have been no new safety concerns reported since the 24-month follow-up, and none of the patients required additional glaucoma surgeries during the study period.
“Similar to any new approach, we are very focused on assuring efficacy and safety. Ciliatech is excited and proud to present longer-term data on its novel CID implant, Intercil Uveal Spacer. These latest results showing a sustained decrease in IOP, in conjunction with a remarkable IOP-lowering medication decrease, confirm the CID concept, whereby the IOP is controlled without the need to open the anterior chamber of the eye," Olivier Benoit, CEO of Ciliatech, said in a company news release. “Our novel approach demonstrates an unprecedented level of efficacy, with an equally reassuring safety profile. Going forward, these clinical results can be presented to regulatory approval bodies, surgeons, and patients alike to provide assurance and drive uptake of the device on the market.”
Ciliatech said it plans to continue monitoring patients beyond the 3-year mark and expand its research through multicenter studies worldwide to further validate the efficacy and safety of the Intercil Uveal Spacer.
Ciliatech’s CEO, Olivier Benoit, will present the detailed findings in a session titled ‘Cilioscleral Interposition technique and CID – long-term clinical data’ on Thursday, September 5, at 08:40, at The Esferic event hall in Barcelona.
About SAFARI I and II
Ciliatech’s SAFARI clinical trial program—SuprAciliary Filtration Alone Reduces IOP—includes the SAFARI I and II first-in-human studies, which aim to demonstrate the safety and effectiveness of the CID SV13 implant in POAG patients. Using a straightforward Ab-Externo surgical technique, the Intercil Uveal Spacer is placed sub-sclerally, avoiding entry into the anterior chamber. Over 3 years, various efficacy and safety parameters were assessed, supported by Ultrasound Bio Microscopy (UBM) imaging to confirm device placement.