Case Study

Sterile, off-the-shelf, replacement corneas are moving closer to commercialisation, thanks to IKC support.

The technology aims to help overcome the global shortage of human donor corneas, which, due to the complexity of storing and transporting living human tissue, have to be used immediately following donation, and usually only in the country or region where they are donated.

Developed through a collaboration between the University of Nottingham and spin-out company NuVision Biotherapies Ltd., the replacement corneas are manufactured from donated corneas using a drying technique first developed at the University for processing amniotic membrane.

This creates a product that is stable at room temperature and can be rehydrated when required for surgery, enabling it to be easily held in stock for routine or emergency use as needed. A patent for the product has been filed.

Financial support

IKC funding has enabled production methodologies for the dry corneas to be ready for transfer from the University to the cleanroom manufacturing facilities at NuVision, who engaged with the university to license the technology. The grant is also funding the University team, led by Dr Laura Sidney, to carry out biocompatibility tests on the corneas to see how cells in the body would interact with the implant.

Dr Sidney explains: “We want to be sure the cells found within the front of the eye will tolerate the material and spread across it, so that the replacement cornea integrates properly into the eye. Ideally, the cells need to react in the same way they do for donor corneas.”

The next step will be to carry out animal studies before moving to first-in-human trials. NuVision are looking for funding to run a veterinary trial, in which the corneas will be used in small animal surgery to prevent pets losing their sight.

Wider application

Although initially devised as a product for the developing world, the positive reaction the cornea technology received when presented at UK and European ophthalmology and eye banking conferences shows the market could be much larger.

Dr Andy Hopkinson, NuVision CEO, says: “Even in countries with the best transplant services, while some corneal transplants are undertaken, there is still a need for products to repair corneas. Globally at least 12 million people suffer from corneal blindness. Feedback from clinicians is showing us that there could be a market in the UK and Europe for use of the product in trauma and emergency surgery and to repair partial corneal damage.”

For Dr Sidney, support from the IKC has been instrumental to the project. “We simply wouldn’t have got this far without the funding the IKC provided,” she says. “They’ve also given both us and NuVision really helpful advice on other funding streams we could apply for.”