Developed by Israeli firm CorNeat Vision, the artificial cornea CorNeat KPro integrates into the eye with the use of a disruptive, patented nano-fabric, eliminating dependence on donor tissue.
According to the World Health Organization (WHO), approximately two million new cases of corneal blindness are reported annually. A study published last February by Jeffrey O. Wong and Michael A. Puente in JAMA Ophthalmology which analyzed data from 148 different countries discovered that there is on average only one cornea available for every 70 needed.
While efforts to encourage cornea donation must continue, solutions in the realm of bioengineering are emerging. That is precisely the purpose of CorNeat Vision, established in Israel at the end of 2015 to develop, produce and globally distribute a feasible and safe artificial solution for corneal blindness.
The firm’s disruptive technology is a nano-fabric called CorNeat EverMatrix™, a 100% synthetic, nondegradable and porous material that mimics the microstructure of the Extracellular Matrix (ECM).
The ECM is the natural biological collagen mesh that provides structural and biochemical support to surrounding cells. It plays a crucial role in all parts of the eye, from maintaining clarity and hydration of the cornea and vitreous, to regulating angiogenesis, intraocular pressure maintenance and vascular signaling.
That is why the CorNeat EverMatrix™—developed through electrospinning technology—is essential to the CorNeat KPro, a patented, aesthetically discreet corneal keratoprosthesis that provides a long-lasting medical solution for corneal blindness, pathology and injury, freeing patients from the scarcity of natural corneas and their inherent risks, such as the potential for infection and excessive inflammation.
How Does the Artificial Cornea Work?
Gilad Litvin is the Co-Founder and Chief Medical Officer of CorNeat Vision. He explained:
“Attempts at developing artificial solutions for the corneally blind to date had two major shortcomings: relying on human tissue for bridging the gap between the synthetic lens and the human body, and extensive and surgically challenging implantation procedures.
Our solution tackled both these shortcomings. The surgical implantation procedure needed to be straightforward and we needed to use other synthetic means to integrate the optical component with resident ocular tissue.
Additional obstacles that we were able to overcome were allowing a complete ophthalmological exam post operation to improve the follow-up, enabling future surgical interventions (like cataract and retinal surgeries) without removing the device, and delivering a physiological and ideal optical performance to the patient.”
The implantation of the CorNeat KPro takes around 45 minutes. The artificial cornea simply snaps into the patient’s trephined cornea and is then sutured to the eye. A trephine is a circular or cylindrical saw which in this case is used for cutting out circular sections of corneal tissue.
This new process reduces surgical risk as it only requires the eye to remain trephined for less than one minute. Finally, patients can experience normal vision immediately after implantation.
Another advantage of the CorNeat KPro in comparison to its current alternatives is easier healing and retention. After all, the CorNeat EverMatrix™ “skirt” used to integrate the product to the eye stimulates cellular proliferation, leading to progressive tissue integration. That results in faster healing and faster recovery in comparison to prostheses that are either sutured to or attempt integration with the native corneal tissue—tissue that lacks blood vessels and heals very poorly.
In contrast, the CorNeat KPro reliably integrates underneath the conjunctiva, the white part of the eye, an area rich with fibroblasts that heals quickly and vigorously.
Regulation and Future Focus
The CorNeat KPro is currently undergoing a Food and Drug Administration (FDA) 510(k) clearance path and CE marking. Gilad Litvin said:
“Following the first-in-human trial, a number of changes were made to the device, the surgical procedure and the study design. We strongly believe these changes will lead to better results in the upcoming clinical trial.”
The updated lens design focused on strengthening the lens’ rim and posterior teeth, a modification to the posterior turret for easing the device insertion, and the addition of a “step” in the posterior undercut that will provide the surgeon with better tactile feedback when inserting the corneal stump into position.
The lens’ modifications, as well as thinning the skirt and adding holes in it, will hasten the integration of the device with the eye wall securing it for years to come. According to Gilad Litvin, the upcoming clinical trial will begin soon in Israel and Canada and a bit later in the Netherlands and France. Marketing approval is expected by late 2024.
