Gentle Stimulation, Natural Renewal
Retinal Rejuvenation Therapy stimulates a biological healing process that results in cellular rejuvenation, renewing the entire transport mechanism of the retina and improving the hydraulic conductivity of Bruch’s Membrane. In suitable patients, this rejuvenation process preserves or improves functional vision and reduces disease progression.
Ellex 2RT™ utilizes an ultra-short nanosecond laser pulse that allows the precise and specific delivery of laser energy to nano-sized targets within the cellular structure of aging RPE cells – without causing collateral damage to the overlying photoreceptor rods and cones of the retina.
Mechanism of Action
- 2RT selectively targets individual RPE cells.
- Microbubbles around melanosomes expand, coalesce and cause intracellular damage.
- Intracellular structure damaged, leading to individual RPE cell death.
- Extracellular and Intracellular signaling occurs from neighboring RPE cells: neighboring cells migrate and proliferate into vacant cell space and RPE cells divide to produce a new RPE cell.
- Microglial processes extending towards lasered site without any classical signs of stress (gliosis).
- Permeability of Bruch’s membrane improved and transport of fluid across Bruch’s membrane restored.
2RT™ utilizes Nanopix™ Technology comprising solid-state nanosecond laser technology and a pixelated beam profile.
2RT™ induces a mononuclear cell response in the treatment of early AMD, including the stimulation of microglia.
2RT™ eliminate the incidence of heat damage to the retina and surrounding cells in the treatment of CSME.
Changing the Paradigm for AMD
Until now, therapies for Age-Related Macular Degeneration (AMD) have only focused on late-stage treatments that attempt to manage the symptoms experienced by patients — by which stage vision loss, and or damage has already occurred.
Currently, the sole option for the more aggressive wet form of AMD is the administration of expensive and invasive anti-VEGF injections. These are only suitable for advanced or end-stage disease, and merely address complications associated with AMD.
In contrast, 2RT™ Retinal Rejuvenation Therapy enables ophthalmologists the potential to intervene earlier in the disease process with the aim of slowing the degeneration process.
Clinically Proven to Delay Progression to Late-Stage AMD in Selected Patients
The Laser Intervention in Early AMD (LEAD) clinical trial, a large randomized, controlled clinical trial, has demonstrated the potential for 2RT™ to significantly reduce the rate of disease progression in a specific group of intermediate AMD patients. The trial, which enrolled 292 patients, examined whether the application of 2RT™ could delay progression of intermediate AMD to late-stage disease. Each participant was randomly assigned to 2RT™ treatment, or a sham laser procedure (placebo group) and received treatment and/or follow-up over three years.
Despite not reaching statistical significance, when considering all patients enrolled in the trial, there was a trend to delay progression from early to late-stage AMD in those treated with 2RT™ Retinal Rejuvenation Therapy.
Post hoc analyses showed that in patients who did not have coexistent reticular pseudodrusen (RPD), a fatty deposit that is associated with later stages of AMD (76% of patients enrolled), treatment with 2RT™ resulted in a clinically meaningful 77% reduction in the rate of disease progression.
2RT significantly reduced the rate of progression in patients without reticular pseudodrusen (RPD)
For participants without RPD (76% of all participants), the rate of progression to late-stage AMD was significantly reduced (adjusted HR 0.23, 95% CI 0.09–0.59; p=0.002).
ACCESS THE LEAD STUDY
Taking the Heat Out of Photocoagulation
For Diabetic Macular Edema and Proliferative Retinopathy, CW retinal photocoagulation remains a mainstream pathway. The use of CW photocoagulation to treat retinal disease represents a two-fold challenge. First — the treatment causes irreversible collateral damage to retinal tissue, and, second — it is an often painful procedure for the patient.
Clinical studies have shown 2RT™ can deliver a therapeutic benefit for the treatment of Clinically Significant Macular Edema (CSME) similar to that achieved through thermal retinal photocoagulation laser treatment, but without the collateral damage associated with the conventional method. Using 500 times less energy than retinal photocoagulation, 2RT™ eliminates the incidence of heat damage to the retina and surrounding cells.1