NOVEMBER 11, 2008 -- Ellex Medical Lasers(Adelaide, Australia) announced results of a six-month clinical study for the treatment Retina Regeneration Therapy during this week's American Academy of Ophthalmology annual meeting (November 7-11, Atlanta, GA). The results show that Ellex's 2RT laser is clinically safe and effective in the treatment of macular edema secondary to diabetic retinopathy. The results were presented by Professor John Marshall, PhD, FRCPath, FRCOphth (Hons), of St. Thomas' Hospital, London, who led the study.
"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.
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.
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 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.
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.
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