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Wednesday / April 21.
Homeminews2RT Positive Five-Year Post-LEAD Trial Results

2RT Positive Five-Year Post-LEAD Trial Results

Five-year data shows that 2RT offers a “potential breakthrough approach” to the treatment of patients with intermediate age-related macular degeneration (iAMD), according to Nova Eye Medical and its subsidiary AlphaRET Pty Ltd (AlphaRET).

The Australian-developed laser therapy stimulates a biological healing response in the eye to treat the intermediate stages of AMD and clinically significant macular edema (CSME). By stimulating a natural immune response of the retina, it restores natural metabolite flow and rejuvenates the retinal pigment epithelium – without damaging the photoreceptors or the underlying Bruch’s membrane.

The positive five-year follow-up data was drawn from a sub-study analysis of the multi-centre LEAD Trial for 2RT nano-pulse ophthalmic laser therapy conducted at the Centre for Eye Research Australia (CERA) by Prof Robyn Guymer FRANZCO PhD and colleagues.

We now have a very clear picture of the patient population that we expect will benefit from our innovative 2RT technology

Conducted during 2012-2018, the LEAD Trial was the first time that a laser intervention has been shown to reduce the rate of disease progression in selected patients with iAMD. Specifically, post hoc analyses showed that in patients who did not have coexistent reticular pseudodrusen (RPD), a fatty deposit associated with the later stages of AMD (76% of patients enrolled), treatment with 2RT resulted in a clinically meaningful 77% reduction in the rate of disease progression at 36 months following treatment.1

RPD is a key biomarker of retinal pigment epithelium (RPE) dysfunction and has a high association with progression to late-stage AMD.

2RT Five-Year Post-LEAD Trial Data

Recently published in Ophthalmology Retina, the five year post LEAD trial data has demonstrated that patients without co-existent RPD who underwent treatment with 2RT (2RT Group) achieved a significant 68% reduction in the rate of disease progression at five years, as compared to the Sham Group (adjusted HR = 0.32; 95% CI = 0.16 to 0.65; P = 0.002) ( Figure 1).

The sub-study enrolled 222 patients (76%) from the LEAD Trial, with patients assigned equally to the 2RT Group and the Sham Group respectively.

Commenting on the significance of the five-year sub-study results, Director of Nova Eye Medical, Tom Spurling said, “While the positive five-year 2RT results in patients without RPD form part of a post-hoc analysis, the reduced rate of disease progression in these patients, as compared to patients in the Sham Group, is significant. The ability of 2RT to achieve such a marked reduction in the rate of progression to late-stage AMD over a five-year period is of immense benefit to patients in potentially deferring disease progression and thus maintaining their quality of life. It also supports our previously stated position that 2RT offers a potential breakthrough approach to the treatment of AMD.”

The five-year post-LEAD review also provides critical input into the Company’s planned 2RT FDA study to obtain regulatory clearance in the USA, helping to affirm the patient inclusion and exclusion criteria.

Mr Spurling continued, “We now have a very clear picture of the patient population that we expect will benefit from our innovative 2RT technology. This forms the basis of our pivotal study design considerations and discussions with the US FDA and the filing of an Investigational Device Exemption (IDE).”

The published study can be viewed at doi.org/10.1016/j.oret.2021.02.015.

 

Reference

  1. Guymer RH, et al. Sub-Threshold Nanosecond Laser Intervention in Age-Related Macular Degeneration:

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