Nova Eye Medical has published two-year data for its iTrack ab-interno canaloplasty procedure, which it says showed an average reduction in mean intraocular pressure (IOP) of 30%, irrespective of whether it was performed standalone or with cataract surgery.
The medical technology company that originated in Adelaide and has operations in Fremont, California, announced the results of a peer-reviewed publication of 24-month data for its minimally invasive glaucoma surgery (MIGS) technology, which also demonstrated reduced medication dependence and utility across all grades of glaucoma severity.
Published in Clinical Ophthalmology, the retrospective case series by Dr Mark Gallardo – a pioneer of the tissue-sparing procedure and ophthalmologist at El Paso Eye Surgeons in the US – assessed the efficacy and safety outcomes iTrack in 60 eyes with primary open-angle glaucoma (53 patients).
He compared the efficacy outcomes of iTrack as a standalone procedure (iTrack-alone) versus in combination with cataract surgery (iTrack+phaco), as well as the procedure’s ability to reduce both IOP and medication burden in mild-to-moderate and severe glaucoma.
According to Nova Eye, iTrack demonstrated a significant and stable reduction in IOP of more than 30% from baseline in both the iTrack-alone and iTrack+phaco groups at 24 months. In the iTrack-alone group, IOP reduced by 34% from 21.6±5.7 mmHg to 13.8±3.1mmHg. Patients in the iTrack+phaco group achieved a similar IOP reduction, with the mean falling by 31% from 19.8±3.9 mmHg at baseline to 13.2±2.1 mmHg at the 24-month visit (P=0.512).
It’s understood the results will now form part of Nova Eye’s application to the Medicare Services Advisory Committee as it considers iTrack’s inclusion in existing item number 42504 in Australia. The current wording only allows for implantation of a micro-bypass stent into the trabecular meshwork.
“When iTrack is an available treatment option, it is usually one of my first choices because it rejuvenates the natural outflow system while sparing both the angle and the tissue from permanent adulteration,” Gallardo said.
“There is little damage to ocular tissue and no implant, so it is one of the most minimally invasive of all MIGS procedures and rarely causes postoperative complications.”
The reduction in medication use was also statistically significant in both groups at 24 months, the company reported, decreasing from 3.0±0.7 to 2.1±1.3 in the iTrack-alone group, and from 2.5±1.1 to 1.3±1.2 in the iTrack+phaco group (P<0.001). Patients in the iTrack-alone group also had a significantly higher baseline medication burden.
Effective across all grades of severity
The 24-month case series also assessed the efficacy outcomes of iTrack in mild-to- moderate glaucoma compared to severe glaucoma. Of the 60 eyes included, severity was categorised as mild (38%), moderate (17%) and severe (38%).
Nova Eye reported iTrack achieved similar reductions in mean IOP at the 24-month mark for cases of mild- to-moderate and severe glaucoma at 33% and 34%, respectively.
While MIGS procedures were first introduced to the fill the surgical treatment gap in mild-to-moderate cases, according to Gallardo, the ability to also deploy iTrack in severe glaucoma offers the potential to defer or eliminate invasive surgical options.
“Given its benign nature, the iTrack canaloplasty microcatheter can be used earlier in the disease process to reduce IOP and alleviate the burden of compliance and side effects associated with medications,” he said.
“It can also be used in patients with more advanced disease who have previously undergone non-ablative MIGS procedures like trabecular micro-bypass, should they suffer from an elevated IOP or an unwanted dosage of topical glaucoma medications.”
Nova Eye president Mr Joe Bankovich said the result across all grades of glaucoma severity spoke “to the significant utility of iTrack in clinical practice”.
The paper, ‘24-month efficacy of viscodilation of Schlemm’s canal and the distal outflow system with iTrack ab-interno canaloplasty for the treatment of primary open-angle glaucoma’, can be accessed here.