14 October 2013

Ellex Announces Release of Positive Pilot Study Results for 2RT Treatment of Early AMD

Key Findings:

  • 44% reduction in accumulation of drusen deposits; drusen are key important risk-factor for progression of AMD to its blinding end stage.
  • 64% of patients at the greatest risk of AMD progression improved sufficiently to be removed from this category.
  • Important clinical evidence step for CE Mark in Europe.

Adelaide, Australia, 10 October 2013 – Ellex Medical Lasers Limited (ASX:ELX), a pioneer in medical technologies for the diagnosis and treatment of eye disease, today announced that the results of a pilot study to investigate the efficacy of the Company’s proprietary Retinal Rejuvenation Therapy (2RT) in the treatment of early Age-Related Macular Degeneration (AMD) have been released and published in the peer-reviewed, scientific publication Clinical & Experimental Ophthalmology.

The “2RT for Early AMD” pilot study (ACTRN12609001056280) was conducted in 2009-2011 at the Centre for Eye Research Australia (CERA) under Professor Robyn Guymer, MB, BS, PHD, FRANZCO, Head of Macular Research at CERA.

50 patients with bilateral at risk intermediate AMD were enrolled in the study with a 12-month follow-up period. Drusen are the accumulation of waste deposits in the macula and are a key risk factor to progression to end-stage, blinding AMD. These drusen were reduced in 44% of treated eyes. Of the 11 patients at greatest risk of disease progression (flicker defect >15dB), seven improved sufficiently to be taken out of this high-risk category.

“This is a really important result because currently, when a patient is diagnosed with early AMD they are told that nothing can be done until the disease reaches its late stages, by which time some patients have suffered irreversible vision loss,” said Ellex CEO Mr. Tom Spurling. “With 2RT, we aim to treat the cause of AMD before vision is lost.”

According to Tom Spurling, the publication of the results is a major milestone in the Company’s clinical investigations: “The study concluded that the application of 2RT produced improvements in macula function and appearance amongst the patient cohort and that as such it warrants ongoing evaluation as an early intervention for AMD.”

Until now, treatment options have been restricted to targeting late-stage complications associated with the wet form of AMD, which only accounts for 10-15% of all people who suffer from AMD.

The publication is an important part of the clinical evidence required for Conformité Européenne (CE) registration which, when achieved, will allow the Company to move forward with a definitive commercialisation program for 2RT in the treatment of early AMD in Europe and Australia.

“While this is an important step towards the market introduction of 2RT”, commented Mr. Spurling, “We are accelerating and expanding the current ongoing multi-centre, double-blind, randomized controlled LEAD clinical trial across a larger and more diverse patient sampling in order to validate these clinical findings.”

The Clinical & Experimental Ophthalmology abstract “Nanosecond-laser application in intermediate AMD – 12-month results of fundus appearance and macular function” can be viewed online at: http://onlinelibrary.wiley.com/doi/10.1111/ceo.12247/abstract

Ellex Medical Lasers Limited (ASX:ELX) is a pioneer in the development of medical technologies for the diagnosis and treatment of eye disease. Since 1985, Ellex has evolved from a manufacturing company of primarily OEM products to direct marketing of its own branded products through subsidiaries in the United States, Japan, Germany and Australia, and a network of distribution partners in more than 100 countries. Today, more than 20,000 Ellex laser and imaging systems are used worldwide in the fight against blindness. In more recent times, Ellex has diversified its product range to include distribution of a number of complementary third-party ophthalmic products.

For additional information about Ellex and its products, please visit www.ellex.com

For further information on Ellex, please contact:

Tom Spurling, CEO Victor Previn, Chairman
Ellex Medical Lasers Limited Ellex Medical Lasers Limited
82 Gilbert Street, Adelaide, SA, 5000 82 Gilbert Street, Adelaide, SA, 5000
W +61 8 8104 5293 | M +61 417 818 658 W +61 8 8104 5200 | M +61 414 661 994
tspurling@ellex.com vprevin@ellex.com

 

Maria Maieli, Company Secretary
Ellex Medical Lasers Limited
82 Gilbert Street, Adelaide, SA, 5000
W +61 8 8104 5200
mmaieli@ellex.com

For media enquiries, please contact:

Kate Hunt, Corporate Communications Manager
Ellex Medical Lasers Limited
82 Gilbert Street, Adelaide, SA, 5000
W +61 8 8104 5214 | M +61 404 080 679
khunt@ellex.com