Glaucoma, Minimally invasive glaucoma surgery (MIGS), News, Therapeutics

iTrack six-year data reveals long-term efficacy and safety profile

Nova Eye Medical iTrack Advance six-year data safety efficacy

Adelaide-based Nova Eye Medical has announced the publication of six-year data of its iTrack canaloplasty microcatheter. Published in the Journal of Glaucoma, the data demonstrates its long-term efficacy and safety profile.

iTrack received FDA approval in March 2023, and is described as a stent free, minimally invasive glaucoma surgery (MIGS) that reduces intraocular pressure (IOP) through pressurised viscodilation and catheterisation. This ensures preservation of tissue, as opposed to the traditional ab externo canaloplasty, where the microcatheter is inserted externally.

Conducted by professor Norbert Koerber and Dr Simon Ondrejka, the single-centre study recruited 27 eyes to undergo canaloplasty performed via an ab interno surgical technique. Canaloplasty was performed as a standalone procedure or in combination with cataract surgery, across cases of primary open angle glaucoma and pseudoexfoliative glaucoma.

At the six-year follow up, mean IOP was reduced significantly from 19.9 mmHg at baseline to 14.6 mmHg. There was no statistically significant difference between standalone canaloplasty procedures and those combined with cataract surgery. Additionally, the mean number of medications were reduced by more than 50% at six years.

According to Nova Eye Medical, this is the longest follow-up for ab interno canaloplasty published in the literature.

An internationally renowned glaucoma surgeon and one of the pioneers of the canaloplasty procedure, Koerber has been using the iTrack canaloplasty microcatheter in clinical practice for nearly two decades.

“I was an early adopter of canaloplasty. I have always been a big believer in its stent-free, tissue sparing approach. Unlike other MIGS procedures which stent or remove diseased tissue in the conventional outflow pathway, canaloplasty allows me to work with patient physiology to re-establish the natural flow of aqueous throughout the entire conventional outflow pathway, including the collector channels,” he said.

“Based on the results I have observed with ab interno canaloplasty, I believe that its comprehensive approach, which targets and treats the trabecular meshwork, Schlemm’s canal and collector channels, contributes to its sustained duration of effect, as demonstrated by our recently published six-year data.”

According to Nova Eye Medical chief commercial officer, Ms Kate Hunt, this study will help to continue to drive increased surgeon uptake of canaloplasty.

“The results from doctors Koerber and Ondrejka point to a sustained reduction in IOP following canaloplasty in cases of mild-moderate glaucoma. Not only will this data help to build advocacy for canaloplasty in the glaucoma treatment paradigm, but it will also support the commercial roll-out of our next generation iTrack technology, iTrack Advance,” Hunt said.

“This data, while being limited by its small population, does provide compelling real-world evidence in support of working with patient physiology, rather than removing it or stenting it, to deliver effective, long-term reduction in IOP.”

More reading

FDA clears Nova Eye Medical iTrack Advance for US launch

Nova Eye Medical launches study into canaloplasty with iTrack Advance

Nova Eye Medical officially launches next-gen iTrack Advance

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