French medtech company Ciliatech reported promising 36-month follow-up data from its SAFARI clinical trial study program, which seeks to demonstrate the safety and efficacy of its first implantable glaucoma device: the Intercil Uveal Spacer.
First, a refresh on Ciliatech.
Founded in 2017 by a veteran engineer and biotech entrepreneur, Ciliatech is an ophthalmic-specialized medtech company based in southeastern France.
Its core focus: Treating glaucoma
- How: Via its Intercil Uveal Spacer implant, a cilioscleral interpositioning device (CID) for lowering intraocular pressure (IOP) in primary open-angle glaucoma (POAG) patients.
Details on this CID implant, please.
The Intercil Uveal Spacer is a glaucoma implant designed to be placed sub-sclerally with a bespoke and straightforward ab-externo surgical implantation technique to significantly lower IOP.
What makes this unique: The CID implant does this by “leaving the anterior chamber untouched and without altering the eye’s anterior segment,” as well as avoiding the risk of corneal endothelial cell loss.
How is this different from other glaucoma surgical techniques?
Current techniques—minimally-invasive glaucoma surgery (MIGS); filtering incisional surgery; corneoscleral pathway (ab-interno) procedures; and using the uveoscleral pathway—all depend on one key component:
- Creating an artificial channel to improve aqueous humor outflow and, as a result, lower IOP.
And this CID procedure doesn’t?
No, it does not.
Enter in the “cilioscleral” method: This accesses the uveoscleral pathway with an ab-externo approach without needing to create an artificial egress.
- Meaning: It virtually eliminates the challenges associated with aqueous drainage circulation to “take advantage of the natural uveoscleral outflow potency.”
What other benefits are associated with this method?
Due to the anterior chamber being untouched, Ciliatech has reported a marked reduction in postoperative inflammation—a common occurrence with other glaucoma surgeries.
Other advantages include:
- Limited incisional trauma to the conjunctiva
- No damage to the anatomical structures
- The technique is usable for Schaffer grades 1-4 (as the technique is angle agnostic)
See a visual comparison to other surgical techniques.
Any prior clinical data on it?
The company reported 12-month preliminary safety data from its SAFARI 3 trial in September 2023, in which the implant was found to work similarly for both POAG and primary narrow-angle glaucoma (i.e., primary angle-closure glaucoma [PACG]) patients, “without the need to remove the lens.”
By the 12-month postoperative visit:
- IOP was reduced by over 41%
- Baseline: 23.5 mmHg
- Month 12: 13.9 mmHg
- Pharmacological treatments were reduced by over 92%
- Mean medication at baseline: 1.7
- Mean medication at Month 12: 0.1
Even further: 86% of patients were medication-free at Month 12.
As for adverse events (AEs): Very few and mild AEs were reported
Now the SAFARI 1 and 2 studies.
The company’s SupraAciliary Filtration Alone Reduces IOP (SAFARI) clinical trial program was launched in 2020 and features both SAFARI 1 (NCT03736655) and 2 (NCT04770324) studies (and now SAFARI 3).
The two first-in-human (FIH) trials evaluated the original version of the CID implant, which was implanted in a cumulative total of 49 POAG patients.
- Back in 2022: The company reported 12-month follow-up data from SAFARI 1/2 that demonstrated the implant’s “strong potential” to, in conjunction with pharmacological treatments, drastically reduce IOP without entering the eye’s chamber.
Any 24-month follow-up?
Reported in 2023 (from the SAFARI 2 study), Ciliatech presented findings that demonstrated stable IOP over time, within a safe zone range of 15 mmHg:
- The data: 95% of patients were below 21 mmHg (and 81% below 18 mmHg).
Further: 90% of patients were prostaglandin medication-free at 24 months.
And this 36-month data?
Based on results from the 41 patients between the two studies, Ciliatech reported an IOP control of 8.0 mmHg, plus:
- Mean pressure reduction of 33% compared to baseline
- 70% reduction in medication (prostaglandin treatment) dependence
Further: Over the 3-year period, 68% of participants remained medication-free
- To note: There have been no new safety reports since patients’ 24-month follow-up visit.
Have any patients needed additional surgery?
According to the company—none. This goes for all patients treated in the SAFARI clinical trial program.
And this means …
“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,” stated CEO Olivier Benoit.
So what’s next for Ciliatech?
The company is planning to continue following up on its current studies beyond the 3-year mark and pursue global multicenter studies to support the CID implant.
The bigger picture: Ciliatech is also reported to be aiming for FDA approval in the near future.