ATLANTA, Nov. 9 /PRNewswire/ -- Ellex Medical Lasers Limited , a global leader in the design and manufacture of ophthalmic laser and ultrasound systems, today announced the six-month clinical study results for the groundbreaking treatment Retina Regeneration Therapy (Ellex 2RT(TM)) at the annual meeting of the American Academy of Ophthalmology. The results were presented by Professor John Marshall, PhD, FRCPath, FRCOphth (Hons), of St. Thomas' Hospital, London, under whom the study has been conducted.
The six-month results show that Ellex 2RT is clinically safe and effective in the treatment of macular edema secondary to diabetic retinopathy.
"This is a revolutionary treatment because, for the first time, we can obtain all the therapeutic benefits seen with earlier laser treatments, but without the collateral damage," said Professor Marshall.
"Currently, this is the mildest laser therapy to be tested in a clinical setting which has demonstrated a selective and therapeutic effect on the retinal pigment epithelium (RPE)."
Ellex 2RT uses a custom designed, Q-switched green YAG laser that produces very precise, three-nanosecond pulses of 532nm light energy. The laser was developed specifically for Ellex 2RT by the Ellex Advanced Research Team in Adelaide, Australia.
About The Clinical Study
In the clinical study conducted at St. Thomas' Hospital in London, 23 patients (38 eyes) with newly-diagnosed diabetic maculopathy were recruited and treated with Ellex 2RT. Seventeen patients (28 eyes) completed the six-month follow-up examination.
Patients underwent treatment using the Ellex 2RT laser to deliver a modified macular grid pattern, guided by fluorescein angiography.
Retinal changes: Six months after laser treatment, 46 percent of patients had a decrease in their central macular thickness by more than 5 percent from baseline. The central macular thickness remained stable in 39 percent of patients and increased by more than 5 percent in only 15 percent of
patients. In addition, the amount of hard exudates also decreased in more than half of the treated eyes. Visual acuity results: At six months, 43 percent of eyes had an improvement of two or more lines of LogMar visual acuity, while 28 percent showed an improvement of one to two lines of visual acuity.
The visual acuity remained stable in 15 percent of eyes and deteriorated in 14 percent of eyes.
"The six-month results presented at the AAO by Professor Marshall confirm our belief that there is a way to successfully treat diabetic macular edema safely and effectively without a significant visual trade-off," said Simon Luscombe, Ellex CEO. "Our next step is to expand clinical studies to investigate the therapeutic role of Ellex 2RT in other diseases that impact the retinal pigment epithelium, including early Age-Related Macular Degeneration (AMD), drusen and central serous retinopathy."
Ellex confirmed that it has commenced trials in Australia to further validate the effectiveness of Ellex 2RT. This includes double blind randomized control studies for treating Diabetic Macula Edema and Diabetic Retinopathy in conjunction with the South Australian Institute of Ophthalmology and the Royal Adelaide Hospital. An early AMD trial is also planned with the Royal Victorian Eye and Ear Hospital. Results from these trials are expected to be available in the second half of FY09. Further trials are also planned for London.
ABOUT ELLEX 2RT RESEARCH
Ellex 2RT research is funded in part by an A$1.9 million, two-year Commercial Ready Grant awarded to Ellex by the Australian Government to support the development of a new and innovative laser therapy for the treatment of Age-Related Macular Degeneration (AMD) and other retinal diseases. The grant was applied for in order to expand laboratory and clinical research in Australia based on proof- of-principle laboratory work conducted at St. Thomas' Hospital in London under the direction of Professor Marshall.
Ellex Medical Lasers Limited designs, manufactures and sells a complete line of lasers and diagnostic ultrasound systems used by ophthalmologists to diagnose and treat eye diseases. With more than 14,000 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 and Australia, and a network of distribution partners in more than 100 countries. In December 2006 Ellex acquired Innovative Imaging, a leading provider of diagnostic ultrasound devices for ophthalmology, initiating the expansion of its product line beyond lasers. Ellex maintains a strong emphasis on intellectual property and research into new and better treatments to manage and treat the leading causes of blindness.
For additional information about Ellex and its products, please visit http://www.ellex.com.
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