Redefining the
Treatment of
Intermediate AMD
with 2RT®

2RT® is a proprietary, minimally invasive nano-pulse ophthalmic laser therapy, which offers the potential to intervene earlier in the management of age-related macular degeneration (AMD) and thereby eliminate or delay the risk of vision-threatening complications associated with the disease.

With approximately 100 million people afflicted globally by the disease in its early stages, AMD is the most common cause of blindness in industrialized countries.

Until now, there’s been little advance in treating AMD before it progresses to the vision-threatening complications associated with the late stage of the disease, referred to as Wet AMD.

That’s why 2RT® represents such an important breakthrough.

Unique to Nova Eye Medical (ASX: EYE), 2RT® is a non-invasive, nano-pulse ophthalmic laser therapy that has been developed to slow the progression of AMD.

2RT® works by stimulating the rejuvenation of cells in the retina to initiate a healing response that targets the underlying causes of AMD.

An extensive multi-center clinical trial has shown that 2RT® achieves a four-fold reduction in the progression to late-stage AMD for over three quarters of selected intermediate AMD patients.

With 2RT®, ophthalmologists have the potential to intervene sooner for the majority of intermediate AMD patients before a significant threat to their vision occurs.

Early Stage AMD

Based on current estimates, about 85% of people with AMD have the disease in either the early or intermediate stage — and this is estimated to be 100 million people worldwide.

People with early or intermediate AMD are at risk of the disease progressing to the late-stage, advanced form of the disease, which is associated with irreversible vision loss.

What is Macular Degeneration, or AMD?

Age-related macular degeneration (AMD) is a chronic eye disease that can result in distorted vision and/or a loss of central vision.

AMD is the leading cause of blindness in industrialized countries and most frequently affects people over fifty years of age.

In its early stages, AMD is characterized by the presence of waste deposits under the macula — that’s the part of the eye at the center of the retina that processes sharp, clear straight-ahead vision.

The waste deposits, known as drusen, are frequently accompanied by pigmentary abnormalities such as light or dark spots in the macula.

While there have been major advances over the past decade in the treatment of AMD in its late stages, there has been little progress in the treatment of the disease in its early stages.

What’s more, there has been little breakthrough at the early stage of the disease to prevent it progressing to the vision-threatening complications associated with late-stage, advanced AMD.

AMD can be diagnosed with a simple eye examination. Detecting changes early through regular check-ups with an optometrist or ophthalmologist can identify the disease before sight-threatening complications occur.

How does AMD affect vision?

In its early stages, AMD can have little or no effect on vision. As AMD progresses, detailed, central vision is affected and becomes worse. In late, end-stage AMD all detailed central vision may be permanently lost, which can result in legal blindness.

Normal Vision
Vision with AMD

What is 2RT?

2RT® is a proprietary light-based intervention that, when applied early in the disease process, can slow the rate of progression of AMD.

A restorative treatment, 2RT® stimulates a process of cellular rejuvenation, initiating a wound-healing response in the eye.

2RT® features a unique nanosecond pulse of laser light. This ultra-short laser pulse stimulates a process of cellular rejuvenation to treat some of the degenerative processes that cause AMD.

Through extensive pre-clinical trials, 2RT® has been shown to rejuvenate the retinal pigment epithelium, known as the RPE. The RPE is an important layer of cells responsible for supporting the health of the retina.

The ultimate goal of 2RT is to prevent the progression of AMD to its late stages… if we can slow down the rate of (Bruch’s membrane) aging and restore function to what it was when the patient was in their teens, we should be able to significantly delay AMD onset.

2005

Prof. John Marshall and Prof. Ali Hussein conduct seminal 2RT® laboratory investigations at Moorfields Eye Hospital, United Kingdom

2008

Study sites throughout Australia and the United Kingdom conduct animal research to demonstrate efficacy and safety profile of 2RT®

2010

Centre for Eye Research Australia (CERA) conducts human pilot study to demonstrate efficacy and safety profile of 2RT®

2010

Ellex Medical Lasers Limited (now Nova Eye Medical Limited) engineers first generation 2RT® laser device

2012

Patient recruitment commences for multi-center 2RT® LEAD trial

2013

Ellex Medical Lasers Limited (now Nova Eye Medical Limited) receives FDA 510(K) clearance for 2RT® for CSME

2014

Ellex Medical Lasers Limited (now Nova Eye Medical Limited) receives CE Mark for 2RT® for CSME and early AMD

2018

Multi-center 2RT® LEAD trial concludes

2019

Ellex Medical Lasers Limited (now Nova Eye Medical Limited) initiates FDA approval pathway for 2RT® for AMD

2020

Nova Eye Medical is formed following the divesture of the Ellex Laser and Ultrasound business; Ellex 2RT® becomes Nova Eye Medical 2RT®

2RT® DEVELOPMENT MILESTONES

PRE-CLINICAL (Complete), PILOT CLINICAL TRIAL (Complete), CE MARK (“Conformité Européenne”) (Complete), FEASIBILITY CLINICAL TRIAL (“LEAD”) (Complete), PIVOTAL CLINICAL TRIAL, FDA CLEARANCE

About the LEAD Trial

The LEAD trial, which was published in the peer-reviewed journal Ophthalmology, was a randomized, 36-month, multi-center trial that highlighted the potential for 2RT® to significantly delay the degenerative processes associated with AMD in a significant proportion of patients with intermediate AMD.

77% reduction in the rate of progression to late-stage AMD in 76% of suitable patients who received 2RT® over the 36 months of the LEAD Trial.

77% reduction, 76% patients

References

Guymer RH, et al. Sub-Threshold Nanosecond Laser Intervention in Age-Related Macular Degeneration: The LEAD Randomized Controlled Clinical Trial. Ophthalmology. 2018 Sep 19.

Guymer RH, Brassington KH, Dimitrov P, et al. Nanosecond‐laser application in intermediate AMD: 12‐month results of fundus appearance and macular function. Clin Exp Ophthalmol. 2014;42(5):466–479.

Fletcher EL, et al. Nanosecond laser therapy reverses pathological and molecular changes in age related macular degeneration without retinal damage. Federation of American Societies of Experimental Biology. November 2014; 28 (11).

Guymer RH, et al. Nanosecond-laser application in intermediate 
AMD – 12-month results of fundus appearance and macular function. Clin Experiment Ophthalmol. 2013 Oct 3

Casson RJ. et al., Pilot randomized trial of a nanopulse retinal laser versus conventional photocoagulation for the treatment of diabetic macular oedema. Clin Experiment Ophthalmol. 2012 Aug;40(6):604-10

Pelosini L, Hamilton R, Mohamed M, et al. Retina Rejuvenation Therapy for Diabetic Macula Edema. A pilot study. Retina. 2012;0:1–11.

Vessey KA, Ho T, Jobling AI, et al. Nanosecond laser treatment for age-related macular degeneration does not induce focal vision loss or new vessel growth in the retina. Invest Ophthalmol Vis Sci. 2018;59:731–745.

Chidlow G, Plunkett M, Casson RJ, et al. Investigations into localized re-treatment of the retina with a 3-nanosecond laser. Lasers Surg. Med. 2016;48(6):602–615.

Jobling AI, Guymer RH, Vessey KA, et al. Nanosecond laser therapy reverses pathologic and molecular changes in age-related macular degeneration without retinal damage. FASEB J. 2015;29(2):696–710.

Chidlow G, Shibeeb OS, Plunkett M, et al. Glial Cell and Inflammatory Responses to Retinal Laser Treatment: Comparison of a Conventional Photocoagulator and a Novel, 3-Nanosecond Pulse Laser. IOVS. 2013;54(3):2319–2332.

Wood JPM, Shibeeb OS, Plunkett M, et al. Retinal Damage Profiles and Neuronal Effects of Laser Treatment: Comparison of a Conventional Photocoagulator and a Novel 3-Nanosecond Pulse Laser. IOVS. 2013;54(3):2305–2318.

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