Nova Eye Medical has announced an application to secure public funding for its iTrack ab-interno canaloplasty as a standalone minimally invasive glaucoma surgery (MIGS) procedure in Australia has formally progressing to the third and final stage of the assessment process.
The Adelaide medical technology company that has operations in Fremont, California, is asking the Medicare Services Advisory Committee (MSAC) to change item number 42504 to include its iTrack microcatheter technology, and has support from the Australian and New Zealand Glaucoma Society (ANZGS), Glaucoma Australia and The Australian Society of Ophthalmologists (ASO).
Introduced in May last year, item 42504 only mentions trabecular micro-bypass stent surgery in its wording, which Nova Eye says has the unintended consequence of excluding its technology.
The company’s application to include iTrack on the Prostheses List is currently under review by 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 (MBS).
iTrack received Therapeutic Goods Administration (TGA) approval in June 2015 and is approved for use in five major teaching hospitals in New South Wales, Western Australia and Victoria.
The company stated it was confident the unique mechanism of the iTrack procedure –which acts to restore the function of the eye’s drainage system rather than to bypass or change it – combined with its excellent safety profile, will make a significant impact on the glaucoma treatment landscape in Australia.
“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,” Mr Tom Spurling, Nova Eye Medical director, said.
“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.”
He added: “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.”
The company stated that another reason behind the increased adoption in the US 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.
Further, interim prospective data to be presented at the 2021 meeting of the American Society of Cataract and Refractive Surgeons meeting by US surgeons Dr David Lubeck and Dr Robert Noecker has demonstrated minimal endothelial cell loss (ECL) following iTrack ab-interno canaloplasty (performed in conjunction with cataract surgery), with mean ECL recorded at -4.8% at 12 months*. This follows the presentation of data at ANZGS 2020 (-3% at 6 months)1, ASCRS 2020 (-3.1% at 6 months)2, ICGS 2020 (-3.1% at 6 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 this point point a decision will be made regarding whether to include iTrack in the Medicare item 42504.
*Data to be presented at ASCRS 2021, 13-17 August, Las Vegas.Data available upon request.
- Lubeck DM, Noecker RJ. Evaluation of Endothelial Cell Density Following iTrack Ab-Interno Canal Based Surgery. ANZGS 2020 (Paper Presentation).
- Lubeck DM, Singh IP, Noecker RJ. Evaluation of Endothelial Cell Density and Loss Following iTrack Ab-Interno Canal Based Surgery. ASCRS 2020 (Paper Presentation). https://ascrs.confex.com/ascrs/20am/meetingapp.cgi/Paper/68712
- 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).
- Lubeck DM, Noecker RJ. Evaluation of endothelial cell density and loss following iTrack ab-interno canal based surgery. ESCRS 2020 (Paper Presentation).https://www.escrs.org/amsterdam2020/programme/free-papers-details.asp?id=36794
- 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. (https://pubmed.ncbi.nlm.nih.gov/30880108/)
- Samuelson, T et al, A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary OpenAngle Glaucoma and Cataract, Ophthalmology, Jan 2019, pages 29-37 (https://pubmed.ncbi.nlm.nih.gov/29945799/)
NOTE: The information regarding endothelial cell loss and the clinical studies has been amended from the original ASX release.