About Corneal Blindness
Diseases affecting the cornea are a major cause of blindness worldwide. According to the World Health Organization, approximately 2 million new cases of corneal blindness are reported each year. Over 30 million people in the world are legally blind in one or both eyes from corneal injury and disease, while many more suffer from degraded visual acuity. A recent study published in JAMA Ophthalmology* assessed the shortage of corneas at one available cornea for 70 needed.
Several attempts to develop an artificial cornea have failed in creating robust, scalable and reliable solutions. As such, there exists an unmet need for an efficient, long-lasting and affordable solution to corneal pathology, injury and blindness, which would alleviate this suffering and disability and enable patients to fully exploit their vision potential.
*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776
Global Demand
World map showing the supply and demand of corneal transplantation in 148 countries.
"Our survey globally quantified the considerable shortage of corneal graft tissue, with only one cornea available for 70 needed. Efforts to encourage cornea donation must continue in all countries, but it is also essential to develop alternative and/or complementary solutions, such as corneal bio-engineering."*
*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776
CorNeat KPro Advantages
CorNeat KPro is superior to keratoplasty and current keratoprosthetics in the following aspects
Optical Performance
Replicating optimal corneal optics
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Wide field of view
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Simplifying the surgical procedure via direct visualization while
enabling future procedures in a similar fashion
Healing and Retention
Device integrates to the eye wall using nano-fabric that imitates the native ECM
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Fast to heal
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Progressive integration
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Straight forward post-operation recovery
Scalability
Relatively simple, 45-minute operation
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Affordable price
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No time constraints placed on scheduling of the implantation
Safety
No need for tissue
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Cannot carry any infectious agent including COVID-19
CorNeat KPro
The CorNeat KPro is a patented synthetic cornea, which provides a long-lasting medical solution for corneal blindness, pathology and injury. The CorNeat KPro allows corneally blind patients to fully rehabilitate normal vision, immediately following a relatively straightforward implantation procedure. It is a unique and innovative device that utilizes a skirt made out of the CorNeat EverMatrix™ to integrate artificial optics within resident ocular tissue, relieving the need for donor tissue.
Current biological solutions and previous KPros are either sutured to, or attempt integration with, the native corneal tissue, a tissue that lacks blood vessels and heals very poorly. In contrast, the CorNeat KPro reliably integrates underneath the conjunctiva, a vascularized site rich with fibroblasts, which heals quickly and vigorously.
The CorNeat KPro is implanted using a novel and straightforward surgical procedure providing an efficient, therapeutic, and affordable remedy for millions of people with cornea-related visual impairments and is far superior to any available alternative.
Features, Surgical Kit and Procedure
The CorNeat KPro implantation procedure is relatively straightforward and does not require the delicate suturing process needed for connecting the donor corneal tissue to the patient’s native cornea and optically aligning it. The CorNeat KPro snaps into the patient’s trephined cornea and is then sutured to the eye using three nondegradable sutures.
The surgical tools supplied as part of the implantation kit: the marker and the snapper, yield a systematic and accurate implantation process. This procedure is easy to teach and can be learned within a couple of days. The operation minimizes the time the trephined eye is exposed (open sky) to less than one minute, significantly reducing associated risks.
The CorNeat KPro implant's patented design is the result of an extensive, multidisciplinary research and development process. The device, and its wide aperture PMMA lens, provides unprecedented visual performance and a wide field of view, which is significantly superior to tissue and predicates. This also allows physicians to examine the patient's eye and perform surgical procedures post-implantation. An undercut on the posterior side enables the device to easily snap into a trephined cornea and quickly seal the eye. The CorNeat KPro lens is surrounded by a nondegradable porous integrating skirt, which is implanted subconjunctivally.
Once implanted, the skirt material stimulates cellular proliferation and colonization that progressively leads to full tissue integration. The skirt, which is only 100-150 microns in thickness, also includes a set of holes around its circumference through which the conjunctiva adheres to the sclera. Additional holes on the circumference of the lens, which are filled with the same porous material, assist in anchoring the lens to the sclera by means of bio-stitching, as tissue is expected to grow through this area. This process anchors the device to the sclera, ensuring long-term retention. These features together are designed for long-term and reliable integration.
Three pairs of suturing holes on the rim of the lens increase safety. These holes enable the ophthalmologist to secure the device to the eye within minutes. Suturing the device stabilizes the lens, significantly easing the implantation procedure. This also stabilizes the skirt post-operation, which is key to successful biological integration.
The CorNeat KPro lens is designed to enable post-operative ophthalmic examinations and subsequent anterior and posterior segment surgeries (i.e. cataract and retinal surgeries). This is achieved with four openings or “ports,” located on the rim of the lens, at the limbus. Four corresponding indicators which can be viewed through an ophthalmic microscope, direct the surgeon to these ports' locations. This is required as they are located and placed subconjunctivally.
The CorNeat KPro solution is 100% synthetic and does not require the use of donor tissue, therefore it is widely accessible and safe. The device cannot carry infectious agents or cause excessive inflammation, resulting in improved quality of life and more effective patient care.
Indications
Failed keratoplasty
Corneal indications not suitable for keratoplasty, such as:
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Herpes keratitis
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Corneal degenerations
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ICE syndrome
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Aniridia
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SJS
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OCP
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Alkali burns
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Vascularized cornea
First-In-Human (FIH) Implantation
The FIH implantation of the CorNeat KPro took place in January 2021. The surgery was conducted by Prof. Irit Bahar at Rabin Medical Center.
Below at the top left you can see two pictures of the patient's eye. The top picture was taken before the operation and the middle picture was taken immediately following the operation. The dramatic aesthetic impact was already apparent. A couple of weeks later, once the eye healed, the patient's eye looked completely natural.
Below at the bottom left you can see the OCT image, taken immediately following the operation. The corneal remnant sits securely in the undercut and the skirt material is covered with conjunctiva.
At the right you can see the patient's eye with the CorNeat KPro a few months post implantation.
So far, 10 terminally blind patients were implanted with the initial configuration of the CorNeat KPro, restoring vision and independence to most.
The FIH clinical trial was recently concluded, and a pivotal trial is about to be initiated (for more information please see below).
For more information about clinical trials please visit clinicaltrials.gov.
Pivotal Trial
Following the FIH trial, several improvements to the surgical technique, pre/post-op patient care, and the device have been implemented. A pivotal study for evaluating the performance of the final product, will take place in Israel, France, the Netherlands, Canada and the US.
The pivotal trial will be submitted to the respective regulatory authorities in the next few weeks and will include all the implemented changes. All principal investigators who took part in the FIH clinical trial have expressed their willingness and enthusiasm to participate in the pivotal trial as well as two additional principal investigators.
For more information about clinical trials please visit clinicaltrials.gov. (input two links to different trials).
Regulatory Path
The CorNeat KPro is following an FDA 510(k) clearance path and CE Marking, expected to be approved for marketing late in 2024, with the following intended use: permanently replacing an opacified or injured cornea for a patient not suited for corneal transplantation, or where a transplant has failed. The pivotal trial planned, which will include 30-35 patients with a one-year follow-up, is designed to provide the clinical and safety data required for approval.
Given the apparent superiority over donor tissue, the company is planning to conduct a study with broader indications including as first line treatment, which will enable it to expand the device's indications for use.
In China, where there are over five million patients waiting for keratoplasty and only a few thousand transplantations a year, CorNeat Vision is planning a study which will facilitate turning the CorNeat KPro into a primary solution for corneal blindness. The study is planned to start in early 2023 and will include 50-60 patients toward the NMPA (previously CFDA) approval.
The plans above are subject to regulatory approvals and requirements.