24-Month Data Confirms Results of 12-Month Pilot Study of 2RT Non-Thermal, Non-Damaging Method of Action
Supports Potential Use of 2RT Laser to Slow Progression of Age-Related Macular Degeneration (AMD)
ADELAIDE, Australia, May 21, 2014 (GLOBE NEWSWIRE) -- Ellex Medical Lasers Limited (AUST:ELX), a pioneer in medical technologies for the diagnosis and treatment of eye disease, today announced data from a 24-month follow up of the pilot study investigating the efficacy of the Company's proprietary Retinal Rejuvenation Therapy (2RT™) in the treatment of early AMD. The data was presented in summary form by Dr. Erica L. Fletcher of the University of Melbourne, at the Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting in Orlando, FL and is currently being considered for publication in a peer-reviewed journal.
Ellex is a leading developer of innovative medical technologies addressing prevalent ophthalmic conditions such as glaucoma, as well as early- and intermediate-stage AMD. Unlike currently marketed AMD treatments, which only address advanced or late-stage complications of the disease, Ellex's 2RT technology is designed to offer treatment earlier in the disease process, with the aim of slowing or reversing its progression. Following receipt of CE mark approval in February 2014, the first such approval for an early stage AMD treatment, Ellex has begun a limited commercial roll-out of 2RT in Europe, certain Asian, Middle East and South American countries, as well as Canada, Australia and New Zealand.
This strong position in AMD treatment augments Ellex's leading position in the glaucoma surgical device market. On December 31, 2013 Ellex acquired the canaloplasty business of iScience Interventional Inc. As a result of that acquisition and rapid U.S. growth of the Company's SLT laser range for glaucoma treatment, recent industry data shows that Ellex is now a global market share leader in surgical devices for the treatment of glaucoma1.
"These data are an important step forward for Ellex in understanding the full range of potential applications for our proprietary 2RT lasers in the treatment and management of AMD. Following the recent receipt of CE Mark certification for 2RT as a treatment for early-stage AMD, and based on the results of this study, we are excited about the potential use of our technology to slow the progression of AMD," said Ellex CEO, Tom Spurling. "We are proud to be a part of the research conducted by Dr. Fletcher and her team and look forward to further collaboration as we continue evaluating the potential of our technology as a novel, early-stage treatment for this extremely prevalent condition."
Mr. Spurling continued, "With 510(k) clearance as a treatment for diabetic eye disease, which we secured in September 2013, 2RT is expected to accelerate clinical exposure of our technology in the U.S. We believe that this technology is poised to play a key role in our expected growth in the North American market as we build upon the strong U.S. demand for our SLT lasers following their launch in July 2013."
In the study, 51 patients with intermediate AMD were treated in one eye with Ellex's 2RT, a 532nm nanosecond Q-switched YAG laser. Drusen area was graded at baseline, 12 and 24 months following treatment and compared with a 58 patient natural history AMD cohort of similar age range and clinical severity. Patient retinae were examined to assess the acute effect of the laser from 1 hour to 7 days post-treatment. The study showed that nanosecond laser treatment reduced drusen area in 35-40% of treated eyes after 12 and 24 months, compared with reduced drusen area in 5-11% of eyes in the natural history cohort. This work follows a 12-month pilot study, "2RT for Early AMD" (ACTRN 1260900E1056280) conducted from 2009 to 2011 at the Centre for Eye Research Australia (CERA) under Professor Robyn Guymer, MB, BS PhD, FRANZCO, Head of Macular Research at CERA.
ABOUT ELLEX
Ellex Medical Lasers Limited (ASX:ELX) is a pioneer in the development of medical technologies for the diagnosis and treatment of eye disease. Since 1985, Ellex has evolved 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. Today, more than 20,000 Ellex laser and imaging systems are used worldwide in the fight against blindness. Ellex also leverages its sales network by distributing a number of complementary third-party ophthalmic products. Recently Ellex acquired the canaloplasty micro catheter glaucoma treatment, a recurring revenue stream, which Ellex manufactures at a plant in Menlo Park, California.
For additional information about Ellex and its products, please visit www.ellex.com.
ABOUT 2RT
Retinal Rejuvenation Therapy (2RT™) delivers nanosecond pulses of laser energy to stimulate a natural, biological healing response in the eye to stimulate a process of cellular rejuvenation to preserve and/or improve functional vision, reducing disease progression. These nanosecond pulses generate a response by retinal pigment epithelium (RPE) melanosomes, without causing heat to escape beyond the RPE cell walls. These micro-bubbles cause damage to the internal cell structure only: they do not break the cell's outer membrane. This process of regeneration rejuvenates the entire transport mechanism of the retina, improving visual function and 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.
1: Market Scope, February 2014