10,000,000 people with corneal blindness but only 100,000 corneal transplants…
Australian artificial cornea ready for production
Embargo: 9 am Perth, Wednesday, 5 June 2002 
Research from the Lions Eye Institute of Western Australia and Argus Biomedical Pty Ltd has resulted in an artificial cornea that is now ready for commercial release throughout the world.
“Four years of trials in humans have shown that the AlphaCor artificial cornea has the ability to substantially improve sight in patients who are unlikely to have success from a traditional human donor transplant,” says Professor Ian Constable from the Lions Eye Institute of Western Australia.	ASMR
Medical
Research 
Week
June 1-8, 2002
Media contacts:
 Anne Hayward 
0419 893 922
Niall Byrne 
03 5253 1391  	
 “People have attempted to make an artificial cornea for more than 200 years,” he says, “We’ve succeeded with AlphaCor by using a one piece polymer device comprising a clear core that enables vision and a sponge rim that encourages the ingrowth of host cells to anchor it in place in the eye. AlphaCor is the first true artificial cornea.”
AlphaCor is the result of twelve years of research at the Lions Eye Institute of Western Australia, supported by the National Health and Medical Research Council (NHMRC).
Many patients in the clinical trials experienced a visual improvement that enabled them to be classed from legal blindness to functionally sighted.  Although many of the patients studied had poor visual potential due to other diseases in the eye, most patients saw an improvement in vision and no patient lost structural integrity to their affected eye.
The AlphaCor technology was licensed to Argus Biomedical in December 2000. Argus has established a commercial production facility in Perth, and is awaiting approval to use the device in the United States. Approval has also been granted in other countries.
“As a result of these efforts, AlphaCor will soon be commercially available to the world’s leading corneal surgeons,” says Dr Janet Preuss at Argus Biomedical.
“AlphaCor demonstrates how government funded research and development can progress to make a real difference for individuals, savings to the health system, and support the creation of new manufacturing industries,” says Professor Peter Schofield, President, Australian Society for Medical Research (ASMR).
“In the case of Argus Biomedical, a relatively small research investment has led to an invention with the potential to restore sight to millions of people.”
“Yet only 1.5% of our health budget is spent on research – less than $12 per person. The USA spends $157 per person and the UK spends $45 per person.”
“We spend more on Easter Eggs.”
We could make a huge difference in issues such as: 
•	Osteoporosis costs $1.9 billion per annum in direct health costs and a further $5.6 billion in indirect costs – lost earnings, volunteer carers, modifications and equipment
•	Cardiovascular disease is responsible for $3.9 billion of total recurrent health expenditure.  40% of these costs relate to hospitalisation and 15% to nursing home care.
•	Cancer costs an estimated $2 billion in direct health system costs. Skin cancer alone, costs more than $300 million.
•	The direct health system costs of arthritis in Australia are estimated at $2.24 billion in 2000.  Indirect costs triple this amount.  
•	Dementia costs the health system more than $700 million. The cost is projected to increase to $1.7 billion over the next 40 years. 
“Over the next five years there is a strong case for government to dramatically increase the share of the health budget committed to research. The payback will be billions of dollars in reduced health costs, and improved quality of life,” says Professor Schofield
For media interviews contact: 	Janet Preuss, Argus Biomedical, (08) 9381 0844
					Anne Hayward, 0419 893 922
Niall Byrne, 03 5253 1391
For further information: 	ASMR President-elect Dr Moira Clay, 0417 863 688 or visit ASMR website: www.asmr.org.au

Artificial cornea – background information
Although corneal transplants remain the most commonly performed and successful type of organ transplant, a significant shortfall in donor numbers exist, particularly in third world nations.  A large population of patients are also considered unsuitable for corneal tissue grafting because of the high risk of donor graft failure resulting from many underlying or concurrent eye diseases or the inability of the patient to take systemic immunosuppressants. It is estimated that there are only 100,000 corneal transplants performed per annum, a fraction for the 10 million people affected by corneal blindness1.
For more than 200 years, efforts to develop an artificial cornea (or keratoprosthesis) using rigid materials such as quartz, glass and metals have failed. In 1989, researchers led by Associate Professor Traian Chirila at the Biomaterials and Polymer Research Group at the Lions Eye Institute of Western Australia Inc. commenced a programme to develop an artificial cornea using a soft hydrogel polymer. The AlphaCor™ (previously known as the Chirila KPro) is the result of extensive laboratory and clinical research and represents a new area in keratoprostheses, a true artificial cornea.
Multi centre clinical trials, led by Associate Professor Geoffrey Crawford and Dr Celia Hicks at the Lions Eye Institute of Western Australia, which were supported by the National Health and Medical Research Council, have been conducted over the past four years in patients considered at high risk for corneal graft failure. The results have consistently demonstrated better outcomes with AlphaCor than donor tissue for many high-risk indications. Although many of the patients studied had poor visual potential due to other diseases in the eye unrelated to the cornea, many patients experienced a visual improvement that enabled them to be classed from legal blindness to functionally sighted. 
The research also demonstrated that when the device is required to be changed, it could either be swapped for another AlphaCor or replaced with human corneal tissue. No patient in the study lost visual acuity or lost structural integrity to their affected eye. 2,3
The AlphaCor technology was licensed to Argus Biomedical in December 2000. The 18 months of commercialisation activity has seen the establishment of a commercial production facility in Perth, implementation of a quality system that has been audited to TGA and CE Mark (European) standards and a submission made to the FDA for approval to market in the United States. As a result of these efforts, the AlphaCor will soon be commercially available to the worlds leading corneal surgeons. Argus Biomedical has developed a unique surgeon support programme, called ArgusConnect™, which facilitates the recruitment and training of specialised surgeons and provides a mechanism for ongoing data collation to support broader applications for the device.
The development of the AlphaCor, both scientifically and commercially, represents a model case study illustrating how grant funded R&D can be progressed through clinical trials to a global commercial product utilising expertise available in Australia.
1.	Witcher J.P., Srinivasan M., & Upadhay M.P. Corneal Blindness: a global perspective. Bulletin of the World Health Organisation, Vol 79(3) p 214-221, 2001.
2.	Hicks C.H., Crawford G.J., Chirila T.V., Wiffen S., Vijayasekaran S., Lou X., Fitton J.H., Maley M., Clayton A., Dalton P., Platten S., Ziegalaar B., Hong Y., Russo A. & Constable I.J. Development and clinical assessment of an artificial cornea. Prog. Retinal Eye Research, 19(2): 149-170, 2000
3.	Crawford G.J., Hicks C.R., Lou X., Vijayasekaran S., Tan D., Chirila T.V. & Constable I.J. The Chirila Kerataprosthesis: Phase I human clinical trial. Ophthalmology, in press 2001.