Argus makes artificial cornea

In a major advance for ophthalmology, the Lion's Eye Institute (LEI) in Perth has developed a flexible, artificial cornea made of hydrogel polymers.

The cornea, known commercially as the AlphaCor, was developed by LEI team including polymer chemist Assoc Prof Traian Chirila and ophthalmic surgeon Assoc Prof Geoffrey Crawford, and has been licensed to Perth-based spin-off Argus Biomedical for commercialisation.

Crawford, who is the chief clinical investigator working with Argus on the project, presented details of the device at the International Congress of Ophthalmology, held in Sydney recently.

The cornea consists of two parts - a clear core and a porous, spongy skirt, both made from the same polymer, poly 2-hydroxyethyl methacrylate (PHEMA). Cells and blood vessels can infiltrate the skirt, anchoring the implant into place. As the core and the skirt are made from the same chemical, the junction between them is very strong.

The cornea is implanted by a similar technique to that used for donor cornea transplants. The team has performed more than 40 transplants to date in clinical trials being held in several locations in Australia as well as in Singapore.

Dr James Williams, managing director of Argus Biomedical, said that the AlphaCor was easy to insert and also easy to remove if necessary.

According to Williams, while the recovery of sight by the patient varied, it compared well to patients receiving corneal transplants.

"Our view is that we can restore the full visual potential of the patient," he said.

"Depending on the pathology of the eye, we can get very good visual outcomes."

Response to the AlphaCor by the ophthalmology community had been overwhelming, said Williams.

"We've got in the region of 50 surgeons who have come through training already despite the fact that it is not approved yet," he said. US Surgeons were also excited by the technology, said Williams.

He said that Argus was in the process of securing regulatory approval for the AlphaCor both in Australia and overseas.

"We have an application in with the TGA and are optimistic of getting approval soon," he said, adding that they are also waiting for approval from the US FDA.

Argus has also received CE Mark approval for the AlphaCor.

Williams said that only about 100,000 corneal transplants were performed worldwide every year and 20-30 per cent of those were considered high-risk for rejection or failure of the procedure.

Initially the company intends to aim at patients considered high-risk for the current corneal transplant procedure, but with over 10 million suffering from corneal blindness globally, the market size for the artificial cornea is potentially more than 700,000 per annum.

As well as the artificial cornea, the company is developing an orbital implant (similar to a glass eye) made from the same soft polymer.