A clinical trial of Ellex’s 2RT retinal rejuvenation laser as a treatment for intermediate stage age-related macular degeneration (AMD), being conducted by Centre for Eye Research Australia (CERA), is expected to continue following the completion of an interim 18-month review of the initial 157 participants.
The interim review was conducted without unmasking to maintain ongoing trial integrity. As a result of this interim review the trial will continue its full course through to at least April 2018.
The Laser intervention in Early Age-related macular Degeneration (LEAD) trial, led by CERA’s Professor Robyn Guymer, is a double-masked, randomised, sham-controlled trial being conducted over six sites: five in Australia and one in Northern Ireland.
There are 292 participants in the trial. The 292nd participant was recruited and randomised in April 2015.
ABiC may potentially offer better clinical outcomes than any other currently available MIGS procedure
Both Professor Guymer, and The LEAD Trial Safety Committee, an independent review board overseeing safety aspects of the trial, have recommended the trial continue.
Of the announcement Ellex CEO Tom Spurling said “We are very pleased to report that the trial has passed this important milestone and will continue,” said. “This milestone was achieved based on the recommendation from the lead investigator on the trial. The analysis reported a meaningful difference in drusen progression and retinal sensitivity between the two groups, one of which received sham treatment and the other 2RT treatment. It also demonstrated a good safety profile.”
ABiC MIGS for Glaucoma
In early May Ellex presented positive 12-month case series data for the company’s proprietary ABiC minimally invasive glaucoma surgery (MIGS) procedure at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in New Orleans. According to the company, results show that ABiC can effectively reduce intraocular pressure (IOP) and medication dependence in glaucoma patients with minimal complications. Ellex has stated that, 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 is dilated with a viscoelastic to open the natural outflow pathways, including the collector channels. It differs from traditional canaloplasty, 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 to mid stage glaucoma. 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.
Ellex stated that 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, Ellex has achieved sales growth in the USA of 25 per cent (constant US dollar) during the nine months to 31 March 2016, compared with the prior corresponding period, while continuing to work with a number of leading clinicians worldwide to validate the procedure’s efficacy and safety profile.
The case series study, was undertaken in the USA, 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 per cent in IOP and a 50 per cent 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 per cent in IOP and 66.66 per cent 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,” said Mr. 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.”
Victor Previn, founder and Chair of Ellex is featured in mivision this month on page 26.
