• Data support sustained safety and performance of first-generation glaucoma implant CID (Cilio-scleral Inter-positioning Device)
• Results show marked stability of intraocular pressure overtime, in order of 15 mmHg, along with significantly reduced need for glaucoma medication (-85%), and no treatment failure
• Patient quality of life improved, up to 86% remain medication-free, even after 24 months
• Publication of results planned for end of 2023 to convey clinical success of groundbreaking surgical approach
Chavanod (near Annecy), France, March 29, 2023 – Ciliatech, an ophthalmology medtech company developing a new class of implant to treat glaucoma durably, today announces the positive results of a 24-month post-operative follow-up on a clinical trial of CID, its first generation Cilio-scleral Inter-positioning Device.
CID is a different technology to other glaucoma implants, used to improve the drainage of fluid within the eye, thereby lowering pressure to prevent further loss of vision. While all existing surgical techniques or implants penetrate the anterior chamber of the eye, CID is the first ever implant which leaves the anterior chamber wholly intact. It therefore completely overcomes the drawbacks of conventional methods, whose techniques can trigger serious complications, such as a filtration bleb (a small blister of fluid on top of the eye’s surface or underneath the eyelid) or endothelial cell loss, among others.
Against decades of practice and common belief, the goal of the study was to demonstrate that it is not necessary to penetrate the anterior chamber in a glaucoma surgery in order to deliver a sustained IOP decrease, as well as keep patients safely off meds for long periods.
The 24-month results show a marked stability in IOP overtime, averaging within the safe zone of 15 mmHg, as well as a markedly reduced need for glaucoma medication (-85%), and no treatment failure. The results observed in patients showed that CID was safe, with no new adverse event reported since the 12-month follow-up visit.
“The results of a 24-month follow-up are always an important and much-anticipated milestone for any interventional glaucoma treatment. With 86% of patients still medication-free at 24 months, we are extremely pleased with the remarkable results that CID has achieved in showing a very stable IOP and a consistent reduction in medication intake during this period following surgery,” said Olivier Benoit, CEO of Ciliatech.
“These results confirm that entering the anterior chamber of an eye is not necessary to significantly lower IOP and reduce medication, offering net advantages in patient safety and ocular comfort. Patients gain all-important improvements in their quality of life with relief from the burden of the daily intake of drugs and the stress of disease progression,” added Dr Philippe Sourdille, medical director of Ciliatech.
Clinical trial, 24-month post-operative follow-up
The trial was carried out in Yerevan, Armenia, under the supervision of principal investigator Dr. Lilit Voskanyan, ophthalmologist, MD, PhD and head of the Glaucoma Department in Ophthalmology at the Malayan Center. A baseline group of 20 patients enrolled in the study in December 2020; among these 14 participated in the 24-month follow-up.
The patients in the study had Primary Open Angle Glaucoma (POAG), non-controlled by glaucoma medication; none had previously had a glaucoma surgery. They each received a first-generation CID implant as a standalone procedure, using a custom-designed abexterno surgical technique. Patients were then prescribed a prostaglandins treatment for a maximum of one month. IOP, medications and safety parameters were controlled during several follow-up visits by the principal investigator.
None of the patients had to undergo additional incisional therapy, laser or other adjunctive treatments. The results obtained are clinically meaningful, as 78% of patients, each now have an IOP below 18mmHg, and all below 21mmHg.
The data support the sustained safety and performance of the first generation of CID, showing that it is possible to reduce IOP in the long term, without entering the anterior chamber of the eye. Patient follow-up will continue to at least 36 months.
Glaucoma is one of the leading causes of blindness for people over the age of 60. It is caused by the build-up of a fluid in the eye, aqueous humor. This causes the intraocular pressure (IOP) to increase, which damages the optic nerve and leads to vision loss.
“Ciliatech’s glaucoma implant is a disruptive technology upending traditional approaches by showing that the concept of an ab-externo approach, preserving the anterior chamber, does not come at the expense of prolonged IOP reduction. It is possible to have improved safety – no corneal Endothelial Cell Loss (ECL) – and improved performance. CID also significantly improves patient quality of life, as 86% of patients have been medication-free since their first post-op day,” added Olivier Benoit.
Ciliatech will submit the results for publication in a peer-reviewed journal by end 2023.
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. Glaucoma affects 80M people per year worldwide. 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.
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 €6M ($6.5M) in financing.
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