23 November 2012
Ellex Announces Commencement of Patient Recruitment for Clinical Trial of Laser for Treatment of Early Stage Age-Related Macular Degeneration
Adelaide, Australia, 23 November 2012 – Ellex Medical Lasers Limited (ASX:ELX), a global leader in ophthalmic technology, today announced that the Centre for Eye Research Australia (CERA) has commenced patient recruitment in a multi-centre clinical trial to validate the clinical efficacy of Retinal Rejuvenation Therapy (Ellex 2RT™) in the treatment of Early Age-Related Macular Degeneration (AMD).
AMD is a progressive disease affecting the central region of the retina called the macula. The leading cause of blindness in the developed world, AMD affects one in seven Australians over the age of 50.
The clinical trial is being led by Professor Robyn Guymer, MB, BS, PhD, FRANZCO, Head of Macular Research at CERA, who stated “We’re looking for people who have gone along for routine eye checks, or those who have had an eye check because of a family history of AMD and been told by their ophthalmologist or optometrist that they have the start of AMD.”
Professor Guymer stressed that this treatment is not suitable for people who had already developed the advanced form of AMD, either the dry or the wet types of AMD, which will have already threatened vision. Those people who think they might be suitable and are interested in participating should speak to their eye care professional and ask for their details to be sent on to Professor Guymer’s team at CERA. Alternatively, they can call (03) 9929 8373 to leave their details and they will be contacted shortly afterwards.
Following successful pilot clinical studies, which demonstrated the ability of Ellex 2RT™ to halt and reverse the degenerative processes caused by the disease, researchers at CERA and other Australian and international clinical sites will take part in a double-blind, randomised control trial to expand the clinical investigations across a larger and more diverse patient sampling.
The multi-centre trial is a significant milestone in the Company’s commercialisation pathway for Ellex 2RT™.
According to the Deloitte Access Economics Report of May 2011 “Eyes on the Future – A clear outlook on age-related macular degeneration”, the initial form of the disease, known as Early AMD, accounts for up to 80% of all AMD cases. The report estimated that as of 2010, 1.023 million Australians had AMD. The prevalence and incidence of AMD in Australia is typical of the developed world.
The multi-centre clinical trial follows an announcement by the Company in July 2012 that it had secured CE Marking for 2RT in the treatment of Diabetic Macular Edema (DME), facilitating initial product sales in Europe, Australia, New Zealand, several South East Asian, Middle East and South American countries.
The clinical operation of the CERA site of the multi-centre trial is being supported by funding from the National Health and Research Centre and in partnership with the BUPA Foundation. Ellex is providing equipment and technical support.
Ellex Medical Lasers Limited (ASX:ELX) is a global leader in the design and manufacture of ophthalmic laser and ultrasound systems used by ophthalmologists to diagnose and treat eye disease. With more than 16,000 systems delivered to the market, Ellex has evolved since 1985 from a manufacturing company of primarily OEM products, to direct marketing of its own branded products through subsidiaries in the United States, Japan, Germany and Australia, and a network of distribution partners in more than 100 countries. In recent years, Ellex has diversified its product range beyond lasers and ultrasound equipment to include distribution of a number of complementary third-party ophthalmic products.
ABOUT ELLEX 2RT
Over 10 years in the making, Retinal Rejuvenation Therapy (Ellex 2RT™) is a non-thermal laser therapy that stimulates a natural, biological healing response in the eye. Unlike conventional laser treatment, Ellex 2RT™ does not cause permanent collateral damage to the sensitive structures of the eye.
The Ellex 2RT™ laser applies short nanosecond pulses of low-energy light to stimulate a process of cellular rejuvenation to preserve and/or improve functional vision, reducing disease progression. This breakthrough approach retains the therapeutic effect of laser therapy whilst eliminating the thermal tissue damage inherent in conventional retinal photocoagulation laser treatment.
Ellex 2RT™ is performed using a novel laser device designed and manufactured by Ellex.
The Centre for Eye Research Australia is Australia’s leading eye research initiative. It conducts basic, clinical and population-based research to understand disease processes and improve diagnosis and treatment of eye disease.