Nova Eye Medical (ASX: EYE) has achieved a significant clinical milestone with the acceptance of the first peer-reviewed manuscript from its iTrack Registry in the American Journal of Ophthalmology. The study tracked 254 patients (344 eyes) across 13 surgeons and 14 clinical sites in the USA, Australia, Canada and Germany, with follow-up periods ranging between 13 and 28 months.
This Nova Eye iTrack Registry publication transitions iTrack from promising technology to validated treatment option. The prospective, multicentre nature of the data provides real-world evidence across diverse patient populations and surgical settings, a critical factor in driving surgeon adoption and payor engagement. The authors concluded that iTrack canaloplasty significantly reduced intraocular pressure (IOP) and medication burden with a favourable safety profile.
Authors’ Conclusion
“iTrack canaloplasty significantly reduced intraocular pressure and medication burden with a favourable safety profile.”
Combined procedure results show strong efficacy
The dominant cohort in the study involved 313 eyes undergoing combined canaloplasty and cataract surgery. These patients demonstrated dual clinical benefits: IOP reduction and reduced reliance on glaucoma medications. Mean IOP decreased from 17.2 mmHg preoperatively to 14.1 mmHg at last follow-up (p<0.001), whilst medication usage fell from 2.1 to 1.3 medications.
Notably, 61.9% of combined procedure eyes achieved success according to the American Academy of Ophthalmology’s (AAO) Minimally Invasive Glaucoma Surgery (MIGS) Guidelines. This success rate climbed to 83% in eyes with baseline IOP exceeding 18 mmHg, demonstrating particularly strong efficacy in higher-baseline patients. The proportion of medication-free patients increased from 7% preoperatively to 43% at last follow-up.
These results support adoption in the large cataract surgery market, where surgeons can address both vision correction and glaucoma management in a single procedure.
Standalone results and safety profile
The standalone canaloplasty cohort, though smaller at 24 eyes, produced meaningful outcomes. Mean IOP reduced from 20.2 mmHg to 15.3 mmHg, whilst medication usage decreased from 2.3 to 1.5 medications (p<0.01). The proportion of medication-free patients rose from 0% preoperatively to 46% at follow-up.
The safety profile proved favourable across both cohorts. No canaloplasty-related sight-threatening complications were reported. The rate of additional glaucoma procedures stood at 4.9%, including laser treatments. A loss of two or more lines of corrected distance visual acuity occurred in 7.3% of eyes, most commonly in association with pre-existing advanced disease or unrelated ocular comorbidities.
| Measure | Combined Pre-Op | Combined LFU | Standalone Pre-Op | Standalone LFU |
|---|---|---|---|---|
| Mean IOP (mmHg) | 17.2 | 14.1 | 20.2 | 15.3 |
| Mean Medications | 2.1 | 1.3 | 2.3 | 1.5 |
| Medication-Free Rate | 7% | 43% | 0% | 46% |
What is canaloplasty and why does real-world evidence matter?
Canaloplasty is a minimally invasive glaucoma surgery that restores the eye’s natural drainage pathway rather than creating artificial drainage routes. The procedure uses a microcatheter to open the eye’s drainage canal (Schlemm’s canal), allowing fluid to drain more effectively and lowering pressure inside the eye. This approach contrasts with traditional glaucoma surgeries, which often create new drainage pathways but carry higher risks of complications such as infection or excessive pressure reduction.
Real-world evidence holds particular weight with surgeons and payors compared to controlled trial data alone. Why does real-world registry data matter?
- Demonstrates effectiveness outside controlled trial conditions
- Captures diverse patient populations and surgical settings
- Supports payor and regulatory engagement for reimbursement discussions
Surgeons increasingly demand evidence from routine clinical practice before adopting new techniques. The iTrack Registry addresses this barrier by providing prospective data collected across multiple centres, countries and surgeon experience levels. This publication validates iTrack’s performance in the conditions surgeons actually encounter, rather than the idealised environments of controlled trials.
Commercial implications for Nova Eye
The clinical validation delivered by this Nova Eye iTrack Registry publication creates several commercial pathways. The peer-reviewed evidence supports surgeon adoption by providing the real-world data ophthalmologists require before incorporating new techniques into their practice. The study also strengthens market access discussions, giving Nova Eye credible clinical outcomes to present to payors and reimbursement authorities.
The registry itself continues to expand. Established in 2022 as part of the International Glaucoma Surgery Registry (IGSR), the official registry partner of the European Glaucoma Society, it now includes 20 surgeons from 20 global sites. Data on more than 600 eyes have been captured, with 409 having reached 12-month follow-up or longer as of January 2025.
This growing dataset will generate additional publications and evidence, creating a flywheel effect. More data leads to more publications, which drives adoption, which generates more data. The registry’s four primary commercial applications include:
- Surgeon adoption through evidence-based treatment protocols
- Market access validation in diverse clinical settings
- Payor engagement with robust clinical outcomes
- Surgeon education and training programmes
Strategic positioning in the MIGS market
The Nova Eye iTrack Registry publication positions iTrack within the expanding minimally invasive glaucoma surgery (MIGS) market by benchmarking results directly against the AAO’s MIGS Guidelines. This specific validation matters because MIGS represents a growth segment in ophthalmology, with surgeons and patients seeking alternatives to traditional, higher-risk procedures.
Nova Eye’s portfolio addresses both mild-moderate glaucoma through iTrack Advance and severe glaucoma via the Molteno3 platform. The validated clinical evidence differentiates the company from competitors relying on older data or less rigorous evidence frameworks. With sales headquarters in Fremont, California, manufacturing facilities in California and New Zealand, and a global distribution network, Nova Eye can leverage this publication across multiple markets simultaneously.
What comes next for Nova Eye’s clinical program
The iTrack Registry continues to mature, with additional data reaching meaningful follow-up periods. Investors should expect further publications as the dataset grows and longer-term outcomes become available. The company’s global footprint positions it to convert clinical validation into commercial traction across key markets.
Milestones to monitor include:
- Additional registry publications as follow-up data matures
- Payor engagement updates in key markets
- Surgeon adoption metrics and distribution expansion
This peer-reviewed publication represents the first output from an expanding clinical evidence programme. The prospective nature of the registry and its alignment with the European Glaucoma Society’s official registry partner ensures ongoing data quality and clinical credibility.
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