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Interim results of 12-month follow-up study on new implant that significantly reduces Intraocular pressure, while leaving anterior chamber untouched, will be presented at three events in Milan, Italy:
- Ophthalmology futures symposium, September 15, 2022
- ESCRS iNovation® Day, September 16, 2022
- ESCRS Scientific session, September 17 – 20, 2022
Epagny Metz-Tessy (near Annecy), France, September 13, 2022 – Ciliatech, an ophthalmology medtech company developing a new class of implant to treat glaucoma durably, named CID (Cilio-scleral Inter-positioning Device), today announces that the interim results of a 12-month follow-up study on its groundbreaking CID concept show strong potential to mark a new era in glaucoma surgery.
The results will be the first in-human trials to demonstrate that, in conjunction with pharmacological treatments, IOP (Intraocular pressure) can be drastically reduced without entering the eye’s anterior chamber.
Positive outcomes of Ciliatech’s 12-month follow-up study on 42 patients consolidate CID’s proof-of-concept. This consists of a simple and quick surgical technique that, unlike other intracameral implants, works successfully without generating a filtration bleb (a small blister of fluid on top of the eye’s surface or underneath the eyelid), hypotonia (intraocular pressure is too low), antimetabolites (inhibiting a particular cellular function) or risking corneal Endothelial Cell Loss (ECL)
The interim follow-up results draw upon two Ciliatech studies: SAFARI 1[1] (12-month follow-up) and SAFARI 2 (6-month follow-up), which began in late 2020. Two cohorts of 20 and 22 patients in Yerevan, Armenia, living with open angle glaucoma, participated in the studies. They were operated on with one of the first versions of Ciliatech’s implant (SV13) in a monocentric study.
Presentation of study results
Ciliatech will present the interim results first at the Ophthalmology futures symposium, and then at two sessions during the ESCRS meeting; all three presentations taking place in Milan, Italy later this week. At ESCRS, Dr. Lilit Voskanyan, ophthalmologist, MD, PhD and head of the Glaucoma Department in Ophthalmology at the Malayan Center, who conducted the surgical procedures for the study, will deliver a first-hand account of patient outcomes at a scientific session.
“Ciliatech’s selection to present our interim up-to-12-month follow-up study results at three sessions illustrates the strong interest the medical community has in our new concept for treating glaucoma. The results are a true testament to the validity and veracity of our original idea, showing IOP can be reduced significantly, down to the low- to mid-teens, without incurring a bleb or hypotony,” said Olivier Benoit, co-founder and CEO of Ciliatech. “Safety has been demonstrated to be extremely good, showing only the most minor and very mildest complications. Equally important, our IOP results are sustainable over time, with no treatment failure and with more than 83% of the patients being med-free at 12 months. We offer our deepest thanks to Dr. Voskanyan, a highly experienced and rigorous ophthalmic surgeon, who was instrumental in this venture.”
Ciliatech anticipates publishing the complete study results in a peer reviewed journal in Q1, 2023.
Safety first
Today, all the prevailing glaucoma implant methods penetrate the anterior chamber and remain partly in it. It is well-established that any device close to the corneal endothelium is eventually harmful to corneal endothelial cells. In contrast, a CID surgical procedure distances itself from the anterior chamber, making it a very safe and significantly different method to all intracameral implants.
“I am thrilled that the long, hard work of everyone working on this idea has finally come to fruition,” said Philippe Sourdille, co-founder of Ciliatech. “This is the result of many years of glaucoma surgical practice laden with both satisfactory and frustrating outcomes, in parallel with many lab tests and the theoretical research that little by little enabled us to create this new concept in treating glaucoma. We are very glad to contribute to the continuous improvement in glaucoma surgery and believe we can bring it to another level, thanks to our innovation.”
Next steps
With the proof of concept of CID validated, the company is looking ahead to developing a newer version aimed at further improving the ability to reduce IOP capacity, while also simplifying the surgical technique. This new version is currently being tested on narrow angle glaucoma patients, (up to one-third of glaucoma patients, often people of Asian descent), who cannot benefit from the recent progresses in glaucoma treatments and still have to undergo trabeculectomy, a technique dating back 50+ years, or lens extraction. Ciliatech believes its technology may help those patients.
The company is aiming for CE marking and FDA approval by 2024/2025.
Presentation schedule
Ophthalmology futures symposium
- Topic: ‘Ciliatech, transforming glaucoma surgery’
- Speaker: Olivier Benoit, CEO
- Thursday, September 15, at 12:20 – Hotel Principe di Savoia Milano
ESCRS iNovation® day
- Topic: ‘Cilioscleral interposition device (CID): a new class of glaucoma surgery implant’
- Speaker: Dr Philippe Sourdille, medical director
- Friday, September 16, at 13:15 – ESCRS Day Session 6 – Milano convention centre
ESCRS Innovation Summit / Scientific Session
- Topic: ‘Supraciliary drainage without entering the anterior chamber and without bleb: a totally new glaucoma surgery concept’
- Speaker: Dr Lilit Voskanyan, surgeon and investigator for CID
- Sunday September 18, at 15:00 – ESCRS scientific symposium – Milano convention centre, E-Poster Area in Hall 4
About Ciliatech
Ciliatech, a medtech company specialized in ophthalmology, is developing a new class of implant to address the increasing need to treat glaucoma durably and with zero adverse effects. The company’s groundbreaking concept CID (Cilio-scleral Inter-positioning Device) is the first implant in the industry to reduce Intraocular pressure (IOP) without penetrating the anterior chamber or creating subconjunctival filtration – critical criteria that overcome the most serious complications and shortcomings of other glaucoma surgical techniques. As CID is embedded between only two areas of the eye (uniquely between the ciliary body and the sclera), it offers the unparalleled advantage of unlocking the natural uveoscleral pathway without altering the anterior segment of the eye. CID surgery also uses the same standard skills currently employed by glaucoma specialists and cataract surgeons; the procedure is readily transferable to all types of primary open angle adult glaucoma. The implant is applicable as a standalone procedure for glaucoma, an aging disease that, globally, affects 80M people per year; or it can be combined with cataract removal.
Founded in 2017 by ophthalmic surgeon and inventor Philippe Sourdille, and Olivier Benoit, a veteran engineer and biotech entrepreneur, Ciliatech recently launched a third clinical trial to test the latest generation of the implant. The company is located near Annecy, France, and to date has raised €2M in financing.
www.cilia.tech
[1] SAFARI = SuprAciliary Filtration Alone Reduces IOP
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