CILIOSCLERAL INTERPOSITION DEVICE (CID): 24M FOLLOW-UP

Presenting Author: Mr Olivier BENOIT
Country: France
mailto:o.benoit@cilia.tech

CILIATECH develops the first implant in the industry to reduce IOP without penetrating the anterior chamber nor creating subconjunctival filtration.

CILIATECH’S implant (invented by Dr SOURDILLE) is a Cilioscleral Interpositioning Device (CID) made of hydrophilic hydrogel used in IOLs. This platelike device (6*4*0.4 mm) is designed to separate the sclera and the ciliary muscle that in normal conditions are in contact: it removes a local obstacle to uveoscleral outflow and increases access to scleral and conjunctival vessels.

With an ab-externo approach, a CID surgery uses the same standard skills currently employed by glaucoma specialists and cataract surgeons, it lasts less than 15 minutes and only needs 2*2 mm penetrating incisions in the sclera before pulling the implant underneath, the conjunctiva is spared. This technique offers the unparalleled advantage of leaving the Anterior Chamber (AC) fully intact and being angle agnostic.

A 1st generation of the CID was tested in 41 POAG patients (20 receiving 1, 21 receiving 2 overlapped devices). Combined outcomes after 24 month follow-up are (n=27): IOP reduced by 38% from 24.7 to 15.2 mmHg, meds down by 88% from 1.7 to 0.2, 85% of patients still drop free at M24. There was no adjunctive treatment, no failure. The safety profile appeared to be very good with almost no complications reported, not even mild ones.

A 2nd generation was tested in 23 POAG and 26 PACG patients in 2022. M6 outcomes show even nicer results (n=31): IOP reduced by 40% from 23.8 to 14.0 mmHg, meds down by 96% from 1.7 to 0.1, 94% of patients still drop free at M6. There was no adjunctive treatment, no failure. The safety profile appeared to be very good, only few cases of transient low-IOPs events resolved without sequelae. Results for POAG and PACG patients are the same.

As key takeaways: a CID

  • Is highly effective on reducing IOP for both POAG and PACG
  • Is safe: as it does not enter into the AC there is lower risk for ECL, intraocular inflammation, cataract progression, very low number and very mild side effects
  • Provides improved quality of life: patients have very little to no pain after the surgery, need for postoperative visits or procedures is reduced, vision is minimally affected, and patients are freed from daily medication intake while their sight is preserved

 

The surgical technique:

  • Is simple and non-bleb-forming

  • Uses an ab externo approach: can be used for any angle conformation

  • Can be implanted in all quadrants of the eye

  • Provides no loss of chance: it spares conjunctiva for future bleb-forming procedures, the use of conventional techniques in the eye remains possible

 

24M outcomes abstract submitted to ESCRS Vienna programm committee

Founded in 2017, Ciliatech closed a financing round of 3.5 M€ beg. 2023 to support CE marking activities. CILIATECH will organise another financing round end 2023 to support USA FDA approval process.