18 April 2016

12-Month Data Highlight the Safety and Efficacy of Ab-Interno Canaloplasty in Primary Open-Angle Glaucoma

Adelaide, Australia, 18 April 2016 – Adelaide, Australia. Ellex Medical Lasers Ltd is pleased to announce findings from a 12-month case series review of 228 patients with primary open-angle glaucoma (POAG) which show that ab-interno canaloplasty (ABiC) helps to reduce intraocular pressure (IOP) and medication dependence with minimal complications.

ABiC is an FDA-approved evolution of “tried-and-tested” traditional ab-externo Canaloplasty, a bleb-free procedure that uses Ellex’s proprietary iTrack™ 250-micron microcatheter to circumferentially viscodilate Schlemm’s canal in order to restore natural aqueous outflow. ABiC differs from traditional canaloplasty only in that it does not require a tensioning suture to maintain the IOP reduction and the procedure spares conjunctival manipulation for future procedures if required. Like traditional Canaloplasty, ABiC can be performed as standalone procedure and in combination with cataract surgery.

The case series study, which was undertaken 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 POAG who underwent ABiC either alone or in combination with cataract surgery. Data for the entire patient cohort show that at 12 months post-ABiC, there was a total average decrease of 30% in IOP and a 50% reduction in medications from 19.0mm Hg ± 6.5SD on 2 ± 1 medications to 13.3 ± 2.0 mm Hg on 1 ± 1 medications. In 127 patients who underwent ABiC combined with phacoemulsification, there was a mean decrease of 23.39% in IOP and 50% reduction in medications from 17.1 mm Hg ± 5.0 on 2gtts ± 1.0 preoperatively to 13.1 mm Hg ± 2.1 on 1gtts ± 1.0 at 12 months. Data in 98 patients who underwent ABiC was similarly compelling. In these patients, there was a total average decrease of 36.74% in IOP and 66.66% in medications. Findings also showed that there was a total average decrease of 38.88% in IOP and 50% in medications in patients with uncontrolled glaucoma (IOP≥ 16 mm Hg, n=161) while patients with controlled glaucoma (IOP≤ 15 mm Hg, n=67) benefited from a 50% reduction in medication use. There were no complications or safety issues.

ABiC is one of several surgical solutions in Ellex’s glaucoma portfolio and offers a treatment for early-mild glaucoma, sitting alongside selective laser trabeculoplasty (SLT) which, like ABiC, can be used as primary, adjunct or medication replacement therapy. SLT has been shown to lower IOP as effectively as medication, has a consistent safety profile, and best of all, it works 24 hours a day, 7 days a week, to keep IOP under control. Canaloplasty, meanwhile, can be used across the entire disease spectrum from mild to advanced glaucoma. A restorative glaucoma surgery, Canaloplasty comprehensively opens up all components of the eye’s natural outflow system to provide long-term reduction in IOP and medication burden

“These data highlight the versatility of ABiC,” said Ellex’s CEO, Tom Spurling. “This minimally-invasive procedure can lower IOP and medication use with or without cataract surgery and is beneficial for patients with uncontrolled as well as controlled glaucoma.” “Ellex is delighted to be able to offer an effective treatment solution right across the glaucoma disease spectrum,” Mr Spurling added.

Dr Khaimi and Dr Gallardo will be presenting data from the 12-month case series as part of the official scientific program at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in New Orleans, USA. Both doctors will also address ASCRS delegates during an Ellex-hosted symposium on Sunday, 8 May 2016. For further information, please contact marketing@ellex.com.

 

ABOUT ELLEX

Ellex Medical (Ellex) is a pioneer in the development of medical technologies for the diagnosis and treatment of eye disease. With more than 20,000 systems delivered to market, Ellex has evolved since 1985 from a manufacturing company of primarily OEM products, to direct marketing of its own branded products through subsidiaries in the United States, Japan, France, Germany and Australia, and a network of distribution partners in more than 100 countries. In recent years, Ellex has diversified its product range beyond lasers and ultrasound equipment to include distribution of a number of complementary third-party ophthalmic products. On 31 December 2013 Ellex acquired the Canaloplasty microcatheterbased glaucoma surgical treatment from iScience Interventional, Inc.

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