First in-human trial of synthetic cornea starts in Israel
The first-in-human implantation of the revolutionary CorNeat KPro synthetic cornea has been approved for 10 corneally blind patients at Beilinson Hospital in Petah Tikva.
CorNeat KPro was developed by CorNeat Vision of Ra’anana. The implant is designed to replace deformed, scarred or opacified corneas and is expected to fully rehabilitate the vision of corneally blind patients immediately following implantation.
The device’s lens, which provides optical quality equivalent to a perfect cornea, integrates with the patient’s ocular tissue using a unique patented nano-fabric skirt placed under the conjunctiva.
''Following rigorous preclinical testing and successful animal trials, we feel confident moving on and proving our device’s safety and efficacy in humans,'' said Dr. Gilad Litvin, CorNeat chief medical officer and the KPro’s inventor.
''Our device’s implantation procedure, which has been developed and perfected in the past four years, does not rely on donor tissue, is relatively simple and takes less than an hour to perform. We expect it will enable millions of blind patients around the world, even in areas where there is no corneal practice nor culture of organ donation, to regain their sight.''
The clinical trial at Beilinson will be led by Dr. Irit Bahar, chief of ophthalmology. Test patients will be people who are not candidates for, or have failed one or more corneal transplantations.
''The technology behind this implant, which enables to permanently and bio-mechanically attach synthetic materials to live human tissue, is key in turning the tide on global corneal blindness,'' said Bahar.
Additional trial sites are planned to open later this year in eight hospitals in Canada, the United States, France, China and the Netherlands.
''CorNeat Vision’s implant is poised to revolutionize corneal transplantation,'' said Canadian ophthalmologist Dr. David Rootman. ''This new solution is completely synthetic and does not rely on donor tissue, which can carry a virus or any other disease – a key differentiator during this COVID-19 crisis, which greatly impacted the availability of corneal tissue.''