Positive Ellex 2RT data demonstrates efficacy in treatment of early Age-Related Macular Degeneration

May 2 2011

Ellex Medical Lasers Limited (ASX:ELX) today announced milestone clinical results for its breakthrough Retinal Regeneration Therapy (Ellex 2RT™) for the treatment of Early Age-Related Macular Degeneration (AMD).

Interim 12-month clinical trial results presented at the 2011 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), Fort Lauderdale, demonstrate the ability of Ellex 2RT™ to sustain improved visual function and drusen reduction in high-risk Early AMD patients. This follows the presentation of interim 6-month results at the 2010 Annual Meeting of ARVO.

“Unlike other treatment options for AMD, which target the late-stage complications associated with the disease, Ellex 2RT offers the potential to treat AMD in its early stages,” said Tom Spurling, Ellex CEO. “This means that, for the first time, AMD can be treated before vision is lost.”

AMD is a progressive disease affecting the central area of the retina called the macula, and is the leading cause of blindness in the developed world. Globally, the early form of the disease accounts for up to 80% of all cases of AMD. To date, no treatment exists to halt the progression of AMD to its advanced stage, which is associated with severe vision loss.

“The fact that we have been able to maintain the positive effects of Ellex 2RT over a 12-month period provides further evidence that Ellex 2RT offers significant hope for the millions of people worldwide who suffer from AMD,” said Mr. Spurling.
“These 12-month results provide a major step towards the market introduction of Ellex 2RT”, commented Mr. Spurling. “Our next step is to secure key regulatory approvals during the 2011 calendar year, based on the positive clinical results achieved to date, and to expand the clinical trials across a larger and more diverse patient sampling in order to validate our clinical findings.”

AMD Clinical Trial Results

The interim 12-month results of 24 patients enrolled in the prospective clinical trial, Ellex 2RT™ for Early AMD, conducted in collaboration with Centre for Eye Research Australia (CERA) at the Royal Victorian Eye and Ear Hospital, demonstrate the clinical efficacy of Ellex 2RT™ in partially halting or reversing the degenerative processes which cause AMD.

At 12 months two-thirds of patients experienced an improvement in visual function and drusen reduction in the treated eye, with the majority of patients also noting an improvement in the fellow, untreated eye. Visual function improved predominately in the regions of greatest dysfunction, which are associated with the highest likelihood of progressing to the advanced stage of the disease. Extensive laboratory research to date shows no evidence of laser damage to photoreceptor cells.

“In the six months since first reporting our results we have observed a sustained improvement in the visual function in the majority of patients”, commented Professor Robyn Guymer, MB, BS, PhD, FRANZCO, Head of Macular Research at the CERA. “This is an extremely positive result. To date there has been no proven intervention in Early AMD that significantly halts or causes regression of the disease process.”

“Our research shows that application of 2RT treatment is safe and painless, and results in both improved visual function and drusen resolution.”

A total of 50 patients are enrolled in the trial, with completion of the 12-month follow-up targeted for the end of December 2011. Preparations for a long-term, multi-centre randomised control trial are currently underway to demonstrate the ability of Ellex 2RT™ to reduce the progression rate to advanced AMD.

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