Nova Eye Medical Limited (ASX: EYE) (Nova
Eye Medical or the Company), a medical technology company committed to advanced
ophthalmic treatment technologies and devices, today announces the establishment of
the iTrack™ Global Data Registry to collect prospective, multicenter, longitudinal data
for canaloplasty in the treatment of glaucoma.
A collaboration with the International Glaucoma Surgery Registry (IGSR), the iTrack™
Global Data Registry will be led by world-renowned surgeons Iqbal Ike K. Ahmed, MD
FRCSC (John A. Moran Eye Center, Utah, USA and Prism Eye Institute, Toronto,
Canada), David Lubeck, MD (Arbor Centers for EyeCare, Chicago, USA) and Nathan
Kerr, BHB, MBChB, MD, FRANZCO (Eye Surgery Associates, Melbourne, Australia),
with the support of an educational grant from Nova Eye Medical.
The iTrack™ Global Data Registry will capture real-world clinical evidence for
canaloplasty across Europe, the Asia Pacific and North America. The Company’s
portfolio of proprietary canaloplasty devices – the iTrack™ and iTrack™ Advance – will
feature in the Registry.
Doctor Kerr is one of the founders of the IGSR and has spearheaded the
development of the iTrack™ Global Data Registry. He will present an interim data
analysis for the iTrack™ Global Data Registry during the Asia Pacific Glaucoma
Congress (APGC), 4-7 August 2022, in Malaysia.
“The iTrack Global Data Registry is providing high-quality, real-world evidence of the
effectiveness and safety of canaloplasty to treat glaucoma and ocular hypertension.
Importantly, it provides a robust means by which to collect uniform data to evaluate
specified outcomes across the spectrum of glaucoma. It will make a major
contribution to our understanding of the clinical effectiveness of canaloplasty and will
enable evidence-based decision making,” commented Dr. Kerr.
According to Dr. Lubeck, the Registry will ensure the fullest utilization of canaloplasty
in daily clinical practice.
“Despite 14 years and tens of thousands of procedures performed globally there is still
much to be learned about the nuances and versatility of the canaloplasty procedure.
The Registry will address key treatment parameters such as patient specific needs,
preferences, type of glaucoma, disease stage and tolerance to prior treatment. The
data collected will help guide surgeon decision-making when planning surgery for their
glaucoma patients.”
According to Ike Ahmed, MD, FRCSC, the Registry will help surgeons determine
when, and how, to use canaloplasty in clinical practice.
“The emergence of new treatment options for glaucoma, including MIGS, and the
possibility to intervene earlier in the treatment paradigm is a huge win for both
patients and surgeons. With the increased array of available treatment options,
however, there is a need to better understand when and how these treatments should
be utilized. With the data to be generated by the Registry my hope is that we can
build an algorithm to inform on the utilization of canaloplasty.”
Tom Spurling, Managing Director of Nova Eye Medical, addressed the Company’s
support of the Registry and why it was important for it to be a surgeon-led initiative.
“We have provided support for the IGSR to accommodate the necessary canaloplasty
data but will not be involved in the management of the Registry data. The Registry
provides surgeons with a platform through which they can independently document
their canaloplasty outcomes. Right from the outset, it was very important that the
Registry be surgeon driven. We are grateful for the active commitment, self-direction,
and follow-through of all participating surgeons, especially doctors Lubeck, Ahmed and
Kerr.”
“We are encouraged by the growing interest in canaloplasty and recognize that more
and more surgeons are turning to real-world data to inform their decision-making. The
Registry will generate highly coveted real-world data on the effectiveness, biomechanics, and safety of canaloplasty. Not only do we expect this data to improve
surgical outcomes with canaloplasty, but by equipping surgeons with a better
understanding of when and how to utilize canaloplasty in their glaucoma surgical
toolkit we anticipate that it will drive increased utilization of canaloplasty.”
The iTrack™ Global Data Registry will follow canaloplasty outcomes for a minimum of 24
months and will enrol more than 300 patients.
IRB Approval information:
WCG IRB (approval number)- 20200728
Australian New Zealand Clinical Trials Registry (ACTRN trial number 12620001021965)
ABOUT NOVA EYE MEDICAL
Nova Eye Medical Limited is a medical technology company that develops,
manufactures and sells a portfolio of proprietary ophthalmic treatment technologies
and devices. Used by eye surgeons in more than 100 countries globally, these
technologies include the iTrack ™ portfolio of canaloplasty devices for the treatment of
glaucoma. The Company also manufactures and sells the proprietary
Molteno3 ® glaucoma drainage device for the treatment of severe or complex
glaucoma. With its sales headquarters based in Fremont, California, Nova Eye
Medical is supported by sales offices in Adelaide, Australia and Berlin, Germany,
and a global network of more than 50 distribution partners. Manufacturing facilities
are located in Fremont, California and Dunedin, New Zealand.