6 May 2016

Ellex iTrack for Glaucoma Demonstrates Efficacy and Safety at 12 Months

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Ellex Medical Lasers Limited (ASX:ELX), a global leader in medical devices for the diagnosis and treatment of eye disease, today announced that positive 12-month case series data for the Company’s proprietary ABiC minimally invasive glaucoma surgery (MIGS) procedure will be presented at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) meeting in New Orleans, 6-9 May 2016. The results show that ABiC can effectively reduce intraocular pressure (IOP) and medication dependence in glaucoma patients with minimal complications. Furthermore, based on these results, ABiC may potentially offer better clinical outcomes than any other currently available MIGS procedure.

A restorative glaucoma surgery, ABiC uses Ellex’s proprietary iTrack microcatheter to comprehensively open up all components of the eye’s natural outflow system to reduce IOP and medication burden. ABiC is an ab-interno procedure, similar to the Company’s traditional ab-externo Canaloplasty procedure, where Schlemm’s Canal and the collector channels are dilated with a viscoelastic to open the natural outflow pathways. It differs from traditional Canaloplasty, however, in that it does not require a tensioning suture to maintain IOP reduction. It is also faster to perform and is ideally suited to patients with early-stage glaucoma. Importantly, ABiC does not require permanent placement of an implant in the eye, preserves tissue and does not require conjunctival manipulation, permitting use of other MIGS procedures in the future, if required.

The Company developed ABiC to address the shortcomings of conventional glaucoma treatment options, which include chronic use of daily multi-dose topical glaucoma medications. ABiC also offers a number of advantages over traditional surgical techniques, such as trabeculectomy, which are invasive and require significant postoperative care.

Since launching ABiC into the fast-growing MIGS market, Ellex has achieved sales growth in the USA of 25% (constant US dollar) during the 9 months to 31 March 2016, compared with the prior corresponding period, whilst continuing to work with a number of leading clinicians worldwide to validate the procedure’s efficacy and safety profile.

The case series study, which was undertaken in the USA by Mahmoud A. Khaimi, MD, (Dean McGee Eye Institute, University of Oklahoma) and Mark J. Gallardo, MD (El Paso Eye Surgeons, Texas), included 228 eyes with mild-to-moderate glaucoma who underwent ABiC either alone or in combination with cataract surgery.

Data for the entire patient cohort (baseline IOP of 21.9 mm Hg) show that at 12 months post-ABiC there was a total average decrease of 30% in IOP and a 50% reduction in medications. In 98 patients who underwent ABiC as a standalone procedure (baseline IOP of 21.5 mm Hg), there was a total average decrease of 36.74% in IOP and 66.66% in medications.

There were no adverse events or safety issues reported.

“These data highlight the versatility of ABiC. It can lower IOP and medication use with or without cataract surgery,” commented Ellex CEO, Tom Spurling.

“It is also important to note that ABiC is the only MIGS procedure indicated for use outside cataract surgery by the FDA. This broadens its clinical application and offers a considerable competitive advantage in the USA over other MIGS procedures, which are limited to use in combination with cataract surgery only.”

 

Dr. Khaimi and Dr. Gallardo will address their experience with ABiC at ASCRS as part of the official scientific program, as per the outline below.

POSTER SESSION: 3:00pm

Saturday, 7 May

“Ab Interno Canaloplasty: Microinvasive Technique for Visocodilating Schlemm Canal Using a Microcatheter 6-Month Data Review”

Mark J. Gallardo, MD

3:05 – 3:15pm

 

MODERATED SESSION: 3:00pm

Saturday, 7 May

“Ab Interno Canaloplasty for Open Angle Glaucoma”

Mahmoud A. Khaimi, MD

3:37 – 3:42pm
In addition to its inclusion in the official scientific program, ABiC will be spotlighted at an Ellex-hosted symposium on Sunday, 8 May (The Marriott Convention Center). Ellex will also host of series of “Meet the Expert” sessions during ASCRS at the Ellex booth featuring Drs Khaimi and Gallardo. Ellex will exhibit at booth #2517 in the ASCRS technical exhibition.
Ellex expects to secure peer-review publication for the 12-month ABiC data in the near future. For more information on ABiC please visit: http://www.ellex.com/physicians/treatment-spotlight/canaloplasty/abic/

 

ABOUT GLAUCOMA
Glaucoma is characterized by progressive, irreversible vision loss caused by optic nerve damage. There are several forms of glaucoma, including primary open-angle glaucoma, primary closed-angle glaucoma, and normal tension glaucoma. The most common form is primary open-angle glaucoma. There is no cure for glaucoma and reducing IOP is the only proven treatment. According to independent industry analysts Market Scope, glaucoma affects more than 80 million people worldwide.

ABOUT ABiC
ABiC is a new, comprehensive MIGS procedure that conserves the clinically proven benefits of 360-degree viscodilation of Schlemm’s canal provided by traditional Canaloplasty, but with the speed and ease of implementation of an MIGS procedure. ABiC has been shown to be effective as both a stand-alone procedure and as a combined procedure performed in conjunction with cataract surgery.

During the procedure, the Company’s patented iTrack microcathether is inserted through a small corneal incision and placed into Schlemm’s canal, a circular channel in the eye that collects aqueous humor and delivers it into the bloodstream. If aqueous humor cannot drain adequately through the trabecular meshwork and Schlemm’s canal, pressure within the eye (IOP) can become elevated. Through a process of 360-degree viscodilation, ABiC is designed to restore the natural outflow pathways for aqueous humor and provide sustained IOP reduction.

To date, ABiC is the only MIGS procedure that successfully and comprehensively addresses all aspects of potential outflow resistance. Whereas other MIGS procedures treat only one aspect of aqueous outflow, ABiC comprehensively accesses, catheterizes, and viscodilates the trabecular meshwork, Schlemm’s canal, and importantly, the distal outflow system, beginning with the collector channels.

 

ABOUT ELLEX

Ellex designs, develops, manufactures and sells innovative product that help eye surgeons around the world to effectively and efficiently treat eye disease. Ellex is a world leader in this field. Headquartered in Adelaide, Australia, Ellex has ophthalmic lasers and devices that treat glaucoma, retinal disease primarily caused by diabetes, secondary cataract and vitreous opacities, as well as age-related macular degeneration. Manufacturing is carried out in Adelaide, Australia and Fremont, California. Sales and service directly to eye surgeons is conducted via subsidiary offices in Minneapolis, Lyon, Berlin and Tokyo. A network of more than 50 distribution partners around the world services other markets.
For additional information about Ellex and its products, please visit www.ellex.com

 

ABOUT ELLEX

Ellex designs, develops, manufactures and sells innovative product that help eye surgeons around the world to effectively and efficiently treat eye disease. Ellex is a world leader in this field. Headquartered in Adelaide, Australia, Ellex has ophthalmic lasers and devices that treat glaucoma, retinal disease primarily caused by diabetes, secondary cataract and vitreous opacities, as well as age-related macular degeneration. Manufacturing is carried out in Adelaide, Australia and Fremont, California. Sales and service directly to eye surgeons is conducted via subsidiary offices in Minneapolis, Lyon, Berlin and Tokyo. A network of more than 50 distribution partners around the world services other markets.

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

For further information on Ellex please contact:

Tom Spurling, CEO
Ellex Medical Lasers Limited
82 Gilbert Street, Adelaide, SA, 5000
W +61 8 8104 5293 | M +61 417 818 658
tspurling@ellex.com

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

Andrew Angus
Investor Relations
M +61 402 823 757
andrewangus@overlandadvisers.com.au