Ellex Medical Lasers Limited announced the results of the Ellex 2RT Laser Intervention in Age-Related Macular Degeneration (LEAD) multicenter clinical trial. The results of the trial were published in Ophthalmology.
According to researchers involved in the LEAD trial, Ellex’s 2RT Retinal Rejuvenation Therapy has shown promise as an effective intervention in selected cases of intermediate AMD, in which patients exhibit large drusen (a form of waste deposit associated with retinal disease), and no signs of cell death (referred to as nascent geographic atrophy or nGA). Although the trial did not meet its primary endpoint for the patient population as a whole, the treatment effect of Ellex 2RT was found to differ based on the clinical classification of AMD. Specifically, there was a four-fold reduction in the rate of disease progression in patients without coexistent reticular pseudodrusen (RPD), a form of waste deposit that is a key biomarker of retinal dysfunction, which characterized 76% of the trial population.
Robyn Guymer, AM, MBBS, PhD, FRANZCO, principal investigator for the LEAD trial and Head of Macular Research at the Centre for Eye Research Australia (CERA) in Melbourne, Australia said, “With careful patient selection, 2RT shows promise in substantially reducing the rate of progression to the late, vision-threatening stages of this devastating disease.”
In a post hoc analysis of 2RT’s treatment effect the LEAD trial demonstrated that, compared to a sham (placebo) treatment, intervention with Ellex 2RT in patients who did not have coexistent RPD at the commencement of the trial resulted in a 77% reduction in the rate of progression from early AMD to late AMD at 3-year follow-up.
At the start of the trial 76% of patients did not have RPD, which suggests that Ellex 2RT may be a beneficial treatment for the majority of intermediate AMD patients with large drusen and no signs of atrophy.
In the 24% of patients with RPD at the commencement of the trial there was a suggested higher rate of disease progression following treatment with Ellex 2RT. The trial investigators postulate that there may be a stage of the AMD disease process whereby RPE integrity is so greatly compromised that treatment with Ellex 2RT is unsuitable. This highlights the critical need for careful selection of the clinical classification of AMD when determining patient suitability for Ellex 2RT.
Dr. Guymer said, “While this isn’t a cure, and it is not suitable for every patient with early stage AMD, the impressive outcomes in reducing progression to late stage disease are important as this is the first time that a laser intervention has succesfuly addressed AMD disease progression in more than 20 years of AMD laser research.”
AMD is the leading cause of severe vision loss in the developed world. Specific treatment options for AMD are currently only available for the late neovascular form of the disease, commonly referred to as wet AMD. Beyond nutritional supplements and lifestyle changes, there has been no specifically targeted medical treatment option available for AMD in its early stages. This is the first time a specific medical treatment in a large randomized trial has been shown to successfully slow progression to vision threatening late-stage AMD. The clinical results of the LEAD trial build on an extensive body of evidence for Ellex 2RT based on a series of pre-clinical and clinical investigations dating back to 2010.
Dr. Guymer commented on the opportunity to undertake further research to confirm the results of the LEAD trial: “With the encouraging results from LEAD we now have an opportunity to reproduce our data in a replication trial. The technique and protocol used, based on careful selection of the clinical classification of AMD, was a criticial consideration. Specifically, we were careful not to include patients that exhibited the very earliest signs of cell death, or nascent geographic atrophy, as well as patients who had wet or dry late-stage AMD in either eye,” said Dr. Guymer.
“The LEAD trial has validated the safety and efficacy of Ellex 2RT as an intervention for many people with intermediate AMD,” said Ellex CEO Tom Spurling. “For the first time, ophthalmologists have the potential to intervene earlier, before significant vision loss occurs.”
Whilst there are many lasers used successfully in ophthalmology to treat a variety of diseases and eye conditions, only Ellex’s patented 2RT technology has shown promise as an an intervention for suitable early stage AMD patients.
“Ellex 2RT features a unique nanosecond pulse of laser light, which is roughly equal to one billionth of a second. This ultra-short laser pulse stimulates a process of cellular rejuvenation to treat some of the degenerative processes that cause AMD,” commented Mr. Spurling.
Over recent years Ellex has undertaken a limited commercial rollout of Ellex 2RT in key global markets in parallel with ongoing clinical investigations. Other than the United States, Ellex 2RT is indicated for the treatment of early/intermediate AMD in all key global markets, including Australia. With the publication of the LEAD data, the company will look to accelerate the expansion of Ellex 2RT worldwide.
Commenting on the significance of Ellex’s patented 2RT technology, Mr. Spurling said: “It is estimated that at least 100 million people worldwide have early stage AMD. This compares with 15 million people who have late-stage neovascular AMD, for which treatment with anti-VEGF injections costs approximately US$5 billion annually. Patient benefits aside, the health-economic benefits of Ellex 2RT in preventing the progression to late-stage AMD are likely to be significant.”
“The development of Ellex 2RT has showcased the strength of Australia’s home-grown engineering and advanced manufacturing experience. It has also involved extensive collaboration between Ellex and CERA, one of the world’s leading eye research institutions. We acknowledge and are grateful for CERA’s sponsorship of the 2RT clinical trials. Whilst treatment with Ellex 2RT is currently not reimbursed through the Australian Medicare system, we are confident that it will play a transformative role in the management of AMD in Australia, and around the world,” added Mr. Spurling.