FDA Grants IDE Approval to Ciliatech for INTERCIL Uveal Spacer Glaucoma Feasibility Study
核心洞察
The FDA has approved Ciliatech's Investigational Device Exemption application to launch a U.S. feasibility study of the INTERCIL Uveal Spacer (搜索) in primary open-angle glaucoma (搜索).
The study is expected to enroll approximately 30 patients across three U.S. clinical sites, evaluating the device's safety and performance.
INTERCIL is a non-resorbable, 26% hydrophilic acrylic implant placed via an ab externo approach to restore uveoscleral outflow without entering the anterior chamber.
Ciliatech has received U.S. Food and Drug Administration (搜索) approval of its Investigational Device Exemption (IDE) application to initiate a U.S. feasibility study of the INTERCIL Uveal Spacer (搜索), its flagship glaucoma device, in patients with primary open-angle glaucoma (搜索) (POAG).
The Chavanod, France-based ophthalmic medtech company expects the study to enroll approximately 30 participants at three U.S. clinical sites. The trial will evaluate the safety and performance of INTERCIL in this patient population, and the results are intended to inform the next steps in the device's U.S. clinical and regulatory development program. No initiation timeframe has been disclosed.
Device Design and Mechanism
INTERCIL is a cilioscleral interpositioning device (CID) designed for sub-scleral placement through a bespoke ab externo surgical technique. Its purpose is to lower intraocular pressure (IOP) in POAG patients by reestablishing natural uveoscleral outflow.
According to the company, the implant is placed between the ciliary body and the sclera without opening the anterior chamber, creating a cyclodialysis cleft, altering the eye's anterior segment, or risking corneal endothelial cell loss. Ciliatech describes INTERCIL as a flat, trapezoidal glaucoma implant made of a hydrophilic acrylic material, designed to create controlled supraciliary spacing to support uveoscleral outflow without entering the anterior chamber or creating a subconjunctival bleb.
The device 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." It consists of a trapezoidal "precision engineered plate" measuring 7 mm x 3.4 mm x 0.6 mm—not a tube, the company emphasized—and features grooves and corrugations intended to maximize outflow from the anterior chamber to the suprachoroidal space.
European Regulatory Status and Clinical Data
Outside the United States, INTERCIL was granted CE certification in August 2025 as a new class of surgical implant "under the scope of medical regulation." The device is reportedly currently in the pre-commercial phase in Europe.
Prior clinical experience comes from the European-conducted Supraciliary Filtration Alone Reduces IOP (SAFARI) clinical trial program. The SAFARA 1 and 2 first-in-human (FIH) studies evaluated a combined total of 49 POAG patients. At 12-month follow-up, the implant—used in conjunction with pharmacological treatments—demonstrated "strong potential" to drastically reduce IOP without entering the eye's chamber.
At 24-month follow-up, the studies demonstrated stable IOP over time within a safe zone range of 15 mmHg, along with 95% of patients below 21 mmHg, 81% of patients below 18 mmHg, and 90% of patients free of prostaglandin medication. Positive 36-month follow-up data based on results from 41 patients across the two SAFARI trials reported IOP control of 8 mmHg.
U.S. Infrastructure Plans
Beyond the feasibility study, Ciliatech has previously shared plans to open a U.S. subsidiary in New York, intended 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. That plan was not mentioned in the latest IDE approval announcement.
Additional Ophthalmology Developments
The IDE clearance was one of several ophthalmology developments reported in the same period.
Nanoscope Therapeutics (搜索) announced that the FDA has accepted and filed a Biologics License Application (BLA) seeking approval of MOGENRY (搜索) (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration in patients with retinitis pigmentosa (搜索) (RP) with severe vision loss. The BLA is supported by positive efficacy and safety data from a Phase 1/2a trial and the RESTORE Phase 2b/3 multicenter, randomized, double-masked, sham-controlled trial, which met its primary and key secondary endpoints with improvements in visual acuity at weeks 52 and 76. MOGENRY was well tolerated, with no treatment-related serious adverse events reported. If approved, it would become the first gene-agnostic therapy to improve vision in patients with RP having severe vision loss.
Tarsus (搜索) announced completion of its previously announced acquisition of Alkeus Pharmaceuticals (搜索), adding worldwide rights to ALK-001, an investigational late-stage molecular entity designed to reduce accumulation of toxic dimers while preserving the normal visual cycle. ALK-001 is being evaluated in the global NORTHSTAR Phase 3 trial, with topline data anticipated in 2029.
Alcon announced the initial commercial launch of the UNITY M ophthalmic microscope in select markets including the U.S. and Japan, followed by Europe. The microscope is the latest addition to Alcon's UNITY platform, combining advanced optics, novel illumination, improved ergonomics, and intuitive usability in a modular design that enables practice-specific customization and future scalability.
Rayner announced expansion of its flagship spiral IOL platform with the introduction of RayOne Galaxy Hydrophobic, to be launched at ESCRS 2026.
Research Highlights
A multicenter, retrospective, interventional cohort study published in the Journal of Cataract & Refractive Surgery evaluated the influence of preoperative astigmatism magnitude and axis on selection between non-toric and low-powered trifocal toric IOLs and their comparative refractive outcomes. The analysis included 1,628 eyes (T00: 786; T20: 842), with lens designation based exclusively on Barrett Toric Calculator recommendations. Despite the T20 group having significantly higher preoperative corneal astigmatism (P<0.001), postoperative manifest astigmatism was statistically equivalent between groups (T00: 0.26±0.26 D vs. T20: 0.24±0.26 D; P=0.634). No significant differences were observed in visual acuity, manifest refraction spherical equivalent, safety, or efficacy indices (P>0.05). However, the T00 group demonstrated higher estimated than achieved postoperative astigmatism (0.33±0.16 D vs. 0.26±0.26 D), whereas the T20 group showed lower estimated than achieved astigmatism (0.10±0.08 D vs. 0.24±0.26 D).
A prospective, multicenter, non-randomized pivotal IDE trial published in Ophthalmology Glaucoma evaluated 24-month safety and effectiveness of excimer laser trabeculostomy combined with phacoemulsification in patients with mild-to-moderate POAG. A total of 318 patients underwent phacoemulsification with IOL implantation followed by excimer laser trabeculostomy (ELIOS System, Bausch + Lomb (搜索)); mean ± SD age was 70.3±7.3 years, medicated IOP at screening was 17.05±3.01 mmHg, and unmedicated diurnal IOP (DIOP) at baseline was 24.53±2.51 mm Hg. Both coprimary endpoints were met at months 12 and 24: a ≥20% reduction in unmedicated DIOP was achieved by 84.2% and 76.1% of patients (P=0.0116 and P=0.0018 vs. performance goals), and mean ± SE change in unmedicated DIOP was −8.17±0.21 mm Hg and −7.35±0.22 mm Hg (both P<0.0001 vs. performance goals). Mean DIOP decreased to 15.98 mm Hg at month 12 and 16.76 mm Hg at month 24, and at month 23, 82.0% of patients were medication-free. No intraoperative adverse events occurred during the ELIOS procedure, and the postoperative safety profile was consistent with that expected following phacoemulsification alone.