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Five-year post-LEAD trial garners positive results for 2RT

Nova Eye Medical has announced positive five-year follow-up data from a sub-study analysis of the multi-centre LEAD trial for its 2RT nano-pulse ophthalmic laser therapy.

Conducted from 2012 to 2018, the LEAD trial was hailed as the first time a laser intervention had been shown to reduce the rate of disease progression in selected patients with intermediate age-related macular degeneration (iAMD).

But at the time, the trial was met with a mixed response after it missed its primary end point before a post-hoc analysis later showed 2RT’s treatment effect was significant, but only in a subset of patients without reticular pseudodrusen (RPD), a fatty deposit that is associated with the later stages of AMD.

Previously, the relevance of RPD in the pathology of AMD was not well understood, and so it wasn’t accounted for in the LEAD trial design. Specifically, the post hoc analyses showed that in patients who did not have coexistent RPD, 2RT resulted in a clinically meaningful 77% reduction in the rate of disease progression at 36 months following treatment.

In the recently published sub-study of the LEAD trial, a total of 222 patients from the original 36-month multi-centre LEAD Trial – which enrolled 298 patients – were followed out to five years. Patients did not undergo further 2RT treatment following the 36-month mark, with the 36-60-month period observational only.

Led by the Centre for Eye Research Australia (CERA)’s Professor Robyn Guymer and published in Ophthalmology Retina, the sub-study demonstrated patients without coexistent RPD who underwent 2RT treatment (2RT Group) achieved a significant 68% reduction in the rate of disease progression at five years, as compared to a sham group.

Commenting on the significance of the results, Nova Eye Medical director Mr 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 review also provides critical input into the company’s planned 2RT Food and Drug Administration study to obtain regulatory clearance in the US, helping to affirm the patient inclusion and exclusion criteria.

“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),” Spurling added.

Nova Eye is commercialising 2RT through its subsidiary AlphaRET.

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