Adelaide-based medical technology company Ellex Medical Lasers (ASX:ELX) has announced the results of the four-year patient follow up from the LEAD clinical trial.
The trial investigated the use of Ellex 2RT Retinal Rejuvenation Therapy in the treatment of intermediate age-related macular degeneration (iAMD).
In September 2018, the company reported the results of LEAD. According to the company, the trial was the first time any form of laser intervention has shown a promising clinical response in a large group of well-defined iAMD patients prior to progression to vision impairing late AMD.
"The trial demonstrated that for selected patients who did not have coexistent reticular pseudodrusen (RPD) at the commencement of the trial (76% of 292 patients enrolled), intervention with 2RT resulted in a significant treatment effect (p=0.002) and a clinically meaningful four-fold or 77% reduction in the rate of progression from iAMD to late AMD versus sham (placebo) treatment at 36 months (Hazard Ratio, HR=0.23)," it said.
RPD is a key biomarker of retinal pigment epithelium (RPE) dysfunction and has a high association with progression to late AMD.
"Of the 292 participants who were randomised into the LEAD study, 183 (63%) attended a 4th year post-LEAD follow up visit. This observational study showed that 2RT therapy has an enduring rejuvenative impact on the retina," added the company.
"At 48 months in patients without coexistent RPD at baseline, there was a 72% reduction in the rate of progression to late AMD versus sham, which remains clinically significant (statistical significance HR=0.28, p=0.002).
According to Professor Andrea Cusumano, MD, PhD, a leading retinal specialist in Italy who has treated a number of patients with 2RT, “The durability of the 2RT treatment response well beyond the 30 months when selected iAMD patients last received this non-invasive therapy is compelling in light of current invasive treatment modalities, which are only approved for wet forms of late AMD and comprise ocular injections that need to be routinely performed every 8- 10 weeks to limit further deterioration in visual acuity and help preserve retinal function.
"Given the excellent safety profile of 2RT, it would be interesting to assess whether additional therapeutic benefit would be conferred by treatment beyond the 30 months of the study.”
Ged Wallace, CEO of Ellex, said, “These data once again highlight the significant restorative effects of 2RT on retinal health in selected patients with iAMD, resulting in a material delay in the time it takes for the disease to progress to late forms of the disease, where vision is impacted and patient quality of life declines markedly.”