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2RT® Retinal Rejuvenation is Ellex’s proprietary, patented laser therapy that stimulates a biological healing response in the eye to treat the intermediate stages of age-related macular degeneration (AMD) and Clinically Significant Macular Edema (CSME).

2RT® targets the compromised retinal pigment epithelium (RPE) to induce the orderly replacement of aged cells within the RPE. Specifically, researchers suggest that 2RT® stimulates a natural immune response of the retina, resulting in drusen clearance and restoration of natural metabolite flow. As a result, the RPE is rejuvenated – without damage to the overlying neurosensory retina (specifically, no damage is caused to the photoreceptors) or the underlying Bruch’s membrane. 

Importantly, 2RT® offers the potential to intervene earlier in the disease process and thereby eliminate or delay the risk of vision-threatening complications associated with AMD – offering a breakthrough approach to the management of AMD patients. 

2RT® has also been shown to be as effective as photocoagulation in reducing the pathology associated with CSME, but with the additional benefit of eliminating thermal damage to the neuroretina.

AMD: How Does 2RT® Work?

The pathogenesis of AMD has several contributing factors, including drusen, RPE changes and photoreceptor atrophy. 

Drusen are a classical marker of AMD and are used in the assessment of disease progression. Disturbances in the retinal pigment epithelium (RPE) and photoreceptor atrophy are also key indicators and markers of AMD progression, with the early pathogenesis of AMD characterized by separation of the photoreceptors from the underlying choroidal vascular bed and the impairment of fluid exchange across Bruch’s membrane.

Clinical studies have shown 2RT® to provide improvements in biological pathways that develop pathological changes implicated in the development of AMD.1 Specifically, 2RT® results in improved permeability of Bruch’s membrane, drusen clearance and improved metabolite flow. Not only has 2RT® been shown to avoid significant collateral damage to the photoreceptors, it can also induce the expression of potentially protective factors, namely protein factors which have autocrine and paracrine effects.2

Targeted at the RPE, 2RT® stimulates a biological healing process that results in migration and proliferation of RPE cells into the lasered area. The new cells undergo a process of adaptation that releases growth factors and extracellular matrix proteins. It also stimulates a natural immune response of the retina, resulting in drusen clearance and restoration of natural metabolite flow to the retinal environment.3

CSME: How Does 2RT® Work?

Pathogenesis of Clinically Significant Macular Edema (CSME) is attributed to abnormal fluid accumulation which results from either excessive leakage of retinal capillaries or loss of pumping capacity of the retinal pigment epithelium (RPE).4,5

In CSME, also referred to as DME, accumulation between the two plexiform layers resulting from retinal capillary leakage is thought to be the cause of disease onset.6,7 Ongoing fluid accumulation causes displacement of retinal structures and eventually connections to the photoreceptors can be broken5, leading to the deterioration of visual acuity.

Even with the introduction of anti-VEGF medication, conventional laser photocoagulation remains a primary treatment option for CSME.8,9 Despite the successful treatment by photocoagulation, the irradiation of photoreceptors by the conventional continuous laser light – which lasts a few milliseconds – induces microscotoma, practically diminishing the effect of therapy which sought to preserve vision. Adverse events from conventional laser photocoagulation have also been reported to result in permanent central vision impairment.10-13

Unlike conventional photocoagulation, 2RT® Retinal Rejuvenation applies a gentle, discontinuous 3 nanosecond laser pulse to the retina to elicit therapeutic resolution of drusen and reinvigorate the RPE without eliciting any damage to photoreceptors. The unique mechanism of action has been proven6 to ablate specific and selected RPE cells via cavitation rather than thermal lysis to prompt natural healing processes to restore RPE function leading to the resolution of edema.

Wound Healing Effect of 2RT®

Research conducted by Professor Erica L. Fletcher MScOptom, PhD (Department of Anatomy and Neuroscience, The University of Melbourne, Australia) and colleagues has shown that the integrity of the (human) RPE remains intact following treatment with 2RT®

Image 1: Pre-treatment. The normal human RPE morphology has a polygonal appearance. Image 2: One week following treatment with 2RT®, the lasered area showed the presence of larger RPE cells at the injury border, with some cells extending into the lesion site. Image 3: One month following treatment with 2RT® the RPE layer was intact; the lesion site was completely covered with enlarged cells.
Wound Healing 2Rt
Image 1: Pre-treatment. The normal human RPE morphology has a polygonal appearance. Image 2: One week following treatment with 2RT®, the lasered area showed the presence of larger RPE cells at the injury border, with some cells extending into the lesion site. Image 3: One month following treatment with 2RT® the RPE layer was intact; the lesion site was completely covered with enlarged cells.

Source: Images courtesy of Erica L. Fletcher MScOptom, PhD  A. I. Jobling et al., “Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage,” The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.

2RT® Preserves Retinal Structure

According to an analysis of human retinal structure following 2RT® at both clinical (Image 2) and suprathreshold (Image 3) levels, 2RT® does not alter retinal structure. When compared with an untreated area of the retina (Image 1), major structural changes or neuronal death were not evident. Additionally, the outer segments of the cone photoreceptors (situated in the outer region of the ONL, outer nuclear layer) remained unaltered despite being situated directed over the laser-treated RPE.

Image 1: Retinal Structure Pre-Treatment. Image 2: Retinal Structure Following Treatment at Clinical Level (0.3 mJ). Image 3: Retinal Structure Following Treatment at Suprathreshold Level (0.6 mJ).
Retinal Structure 2Rt 7B78Bc32F2A01Df6Dfc3784467106598 Copy
Image 1: Retinal Structure Pre-Treatment. Image 2: Retinal Structure Following Treatment at Clinical Level (0.3 mJ). Image 3: Retinal Structure Following Treatment at Suprathreshold Level (0.6 mJ).

Source: Images courtesy of Erica L. Fletcher MScOptom, PhD  A. I. Jobling et al., “Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage,” The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.

Mechanism of Action

The three-nanosecond pulse of 2RT® is designed to exclusively target selected, individual cells within the retinal pigment epithelium (RPE). This unique approach of lethally injuring a small, targeted monolayer of RPE cells triggers the orderly replacement of RPE cells to recreate a normally functioning pigment epithelial layer.

  • 2RT® selectively targets individual RPE cells
  • Microbubbles around melanosomes expand, coalesce and cause intracellular damage and microcavitation to induce individual RPE cell death
  • Extracellular signalling occurs from neighbouring RPE cells: neighbouring cells migrate and proliferate into vacant cell space and RPE cells divide to produce new RPE cells
  • Microglial processes extending towards lasered site without any classical signs of microglial activity (gliosis)
  • Permeability of Bruch’s membrane improved and transport of fluid across Bruch’s membrane restored

    Mononuclear Cell Response of 2RT®

    Research conducted by Professor Erica L. Fletcher MScOptom, PhD (Department of Anatomy and Neuroscience, The University of Melbourne, Australia) and colleagues has shown that 2RT® induces a mononuclear cell response, including the release of microglia. Microglia, the resident immune cell of the central nervous system, is known to remove cellular debris and facilitate healing.

    In the image below, the retinal microglia are shown projecting their processes through the outer nuclear layer toward the laser treatment site, while their cell bodies remain in the ganglion cell layer. 

    Microglia: thin pink strands. Photoreceptors: blue colored outer region. Cells of mononuclear origin: spherical pink globules.
    Mononuclear Cell Response 2Rt
    Microglia: thin pink strands. Photoreceptors: blue colored outer region. Cells of mononuclear origin: spherical pink globules.

    Source: Image courtesy of Erica L. Fletcher MScOptom, PhD  A. I. Jobling et al., “Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage,” The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.

    1. I. Jobling et al., “Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage,” The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.

    2. J.P. Wood, G. Chidlow, M. Tahmasebi, M. Plunkett, R.J. Casson. RESPONSE OF THE RETINAL PIGMENTED EPITHELIUM TO RETINAL REGENERATION THERAPY (2RT) LASER, IN VITRO AND IN VIVO. The Association for Research in Vision and Ophthalmology (ARVO) 2015.

    3. I. Jobling et al., “Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage,” The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.

    4. Tso MOM. Pathology of cystoid macular edema. Ophthalmology. 1982;89:902–915.

    5. Wolter JR. The histopathology of cystoid macular oedema [German]. Albrecht Von Graefes Arch Klin Exp Ophthalmol. 1981;216:85–101.

    6. Pelosini L, Hamilton R, Mohamed M, et al. Retina rejuvenation therapy for diabetic macular edema: a pilot study. Retina. 2013;33(3):548-58.

    7. Antcliff RJ, Marshall J. The pathogenesis of edema in diabetic maculopathy. Semin Ophthalmol. 1999;14:222–32.

    8. Larsson J, Zhu M, Sutter F, et al. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005;139:802–806.

    9. Diabetic Retinopathy Clinical Research Network. Relationship between optical coherence tomography measured central retinal thickness and visual acuity in diabetic macular oedema. Ophthalmology. 2007;114:525–536.

    10. Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence tomography. Am J Ophthalmol. 1999;127:688–693.

    11. Kim BY, Smith SD, Kaiser PK. Optical coherence tomographic patterns of diabetic macular oedema. Am J Ophthalmol. 2006;142:405–412.

    12. Gibram SK, Khan K, Jungkim S, et al. Optical coherence tomographic pattern may predict visual outcome after intravitreal triamcinolone for diabetic macular edema. Ophthalmology. 2007;114:890–894.

    13. Massin P, Bandello F, Garweg JG, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 2010;33:2399–2405.

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