A decision to fund Nova Eye Medical’s iTrack ab-interno canaloplasty as a standalone minimally invasive glaucoma surgery (MIGS) procedure, via the Australian government’s Medical Benefits Scheme, is one step closer. The news comes as interim prospective data demonstrating minimal endothelial cell loss following the procedure is to be presented at the 2021 meeting of the American Society of Cataract and Refractive Surgeons.
The company’s application to secure public funding for its patented device to be used as a standalone MIGS procedure has formally progressed to the third and final stage of the assessment process.
the iTrack procedure… acts to restore the function of the eye’s drainage system rather than to bypass it or change it
The application to include iTrack on the Prostheses List is currently under review by the Medicare Services Advisory Committee (MSAC), an independent body appointed by the Australian Government to assess the allocation of public funding for medical devices and procedures covered by the Medicare Benefits Schedule.
The Company’s application is seeking to amend the existing standalone MIGS Medicare Item Number, #42504, to include its iTrack microcatheter technology, and has garnered support from the Australian and New Zealand Glaucoma Society (ANZGS), Glaucoma Australia and The Australian Society of Ophthalmologists (ASO).
iTrack has been registered in Australia by the Therapeutic Goods Administration (TGA) since June 2015 and is currently approved for use in five major teaching hospitals in New South Wales, Western Australia and Victoria.
Nova Eye Medical has stated its confidence in the unique mechanism of the iTrack procedure, which acts to restore the function of the eye’s drainage system rather than to bypass it or change it, combined with its excellent safety profile, will enable iTrack to make a significant, positive impact on the glaucoma treatment landscape in Australia.
Tissue-sparing, Implant-free Approach
“The majority of MIGS procedures, including trabecular micro-bypass stent surgery, are focal in their approach. That is, they attempt to remove or bypass a particular point of blockage. In contrast, ab-interno canaloplasty aims to remove all points of blockage in the conventional outflow system – and does so without damaging or removing tissue, and without the use of a permanent implant,” said Tom Spurling, Director of Nova Eye Medical Limited.
“iTrack is routinely deployed via an ab-interno approach across the USA and Europe in the treatment of mild-moderate glaucoma, and there is a growing body of clinical evidence attesting to its clinical efficacy and safety profile, both as a standalone MIGS procedure and in combination with cataract surgery.”
“Surgeons in the USA have readily adopted the procedure. This is due, in part, to the fact that it is medically reimbursed with a Category 1 CPT (Current Procedural Terminology) Code,” added Mr Spurling.
Another reason behind the increased adoption of iTrack in the USA and Europe is the tissue-sparing, implant-free approach of the procedure, which preserves both the conjunctiva and the angle for future treatments. It has also been shown to preserve the corneal endothelium.
Minimal Endothelial Cell Loss
Interim prospective data to be presented at the 2021 meeting of the American Society of Cataract and Refractive Surgeons meeting by US surgeons David Lubeck, MD and Robert Noecker, MD has demonstrated minimal endothelial cell loss following iTrack ab-interno canaloplasty (performed in conjunction with cataract surgery), with mean endothelial cell loss recorded at -4.8% at 12 months*. This follows the presentation of data at ANZGS 2020 (-3% at six months),1 ASCRS 2020 (-3.1% at six months),2 ICGS 2020 (-3.1% at six months)3 and ESCRS 2020 (-5% at 12 months).4 The pivotal FDA trials for iStent inject (Glaukos)5 and Hydrus (Ivantis)6 reported mean endothelial cell loss at 24 months of -13.1% (cataract surgery-only control group = 12.3%) and -14.0% (cataract surgery-only control group = 10.0%) respectively.
The final assessment of the company’s application is being completed by a contracted health technology assessment agency, assigned by the MSAC secretariat and will be considered by the Evaluation Sub-Committee (ESC) in the second half of 2021, at which point a decision will be made regarding whether to include iTrack in the Medicare Item Number #42504.
*Data to be presented at ASCRS 2021, 13-17 August, Las Vegas. Data available upon request.
1. Lubeck DM, Noecker RJ. Evaluation of Endothelial Cell Density Following iTrack Ab-Interno Canal Based Surgery. ANZGS 2020 (Paper Presentation)
2. Lubeck DM, Singh IP, Noecker RJ. Evaluation of Endothelial Cell Density and Loss Following iTrack Ab-Interno Canal Based Surgery. ASCRS 2020 (Paper Presentation). ascrs.confex.com/ascrs/20am/meetingapp.cgi/Paper/68712
3. Lubeck DM, Singh IP, Noecker RJ. Evaluation of Endothelial Cell Density and Loss Following iTrack Ab-Interno Canal Based Surgery. ICGS 2020 (Paper Presentation, P060)
4. Lubeck DM, Noecker RJ. Evaluation of endothelial cell density and loss following iTrack ab-interno canal based surgery. ESCRS 2020 (Paper Presentation). www.escrs.org/amsterdam2020/programme/free-papers-details.asp?id=36794
5. Samuelson, T et al, Prospective, Randomized, Controlled Pivotal Trial of an Ab Interno Implanted Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract, Ophthalmology June 2019, pages 811-821 2. pubmed.ncbi.nlm.nih.gov/30880108/
6. Samuelson, T et al, A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary OpenAngle Glaucoma and Cataract, Ophthalmology, Jan 2019, pages 29-37 pubmed.ncbi.nlm.nih.gov/29945799/