Key Clinical Milestone
The Nova Eye iTrack Registry Results demonstrate an 85% success rate in reducing intraocular pressure for patients with baseline readings above 18 mmHg, alongside a 40% mean reduction in medication burden at 12-month follow-up.
Nova Eye Medical (ASX: EYE) has released a significant clinical data update from its iTrack™ Global Data Registry, with 409 eyes now reaching the 12-month follow-up milestone. The registry, which tracks real-world outcomes from canaloplasty procedures performed with the company’s iTrack™ device, has expanded to more than 600 eyes across 20 global surgical sites.
The data reinforces the clinical effectiveness and safety profile of the minimally invasive glaucoma surgery (MIGS) technology in routine practice.
Nova Eye’s iTrack registry hits 12-month milestone with 85% success rate
The 2025 statistical report marks a critical maturity point for the registry, established in 2022 as an independently managed database tracking surgical outcomes. With 409 eyes completing 12 months of follow-up, the dataset now provides substantive evidence of the procedure’s durability in real-world settings.
Patients with baseline intraocular pressure (IOP) greater than 18 mmHg achieved an 85% success rate in IOP reduction, a clinically meaningful outcome for glaucoma management. Across the full cohort, patients experienced a mean 40% reduction in medication burden, indicating potential to reduce long-term reliance on pharmacological therapy.
The registry currently draws data from 20 surgeons across 20 sites globally, with ongoing recruitment expanding the evidence base. Data collection follows a prospective methodology, capturing outcomes as they occur in clinical practice rather than under controlled trial conditions.
This approach provides validation of the iTrack™ technology’s performance outside research environments, supporting market access discussions and payor engagement strategies.
What is canaloplasty and why registry data matters
Canaloplasty is a surgical technique that restores the eye’s natural drainage pathway to reduce intraocular pressure in glaucoma patients. The procedure uses a microcatheter to dilate Schlemm’s canal, the eye’s primary drainage channel, improving fluid outflow without creating permanent openings or implanting devices.
Registry data differs from clinical trial data in its real-world applicability. While trials operate under controlled conditions with strict inclusion criteria, registries capture outcomes from routine surgical practice across diverse patient populations and surgical settings.
This makes registry evidence particularly valuable for payors assessing the technology’s effectiveness in broader clinical use. The iTrack™ Registry’s prospective design, collecting data as surgeries occur rather than retrospectively, strengthens its credibility.
Independent management by participating surgeons, rather than company oversight, further enhances the data’s perceived objectivity. For investors evaluating medtech adoption curves, this independent validation reduces perceived clinical risk and supports the case for sustained market penetration.
Clinical results reinforce iTrack’s safety and efficacy profile
The registry’s safety profile remains notably favourable, with only six adverse events reported across more than 600 eyes. This translates to minimal complications during real-world use, a critical factor for surgeon adoption and payor approval processes.
| Metric | Result | Cohort Size | Clinical Significance |
|---|---|---|---|
| Success rate (IOP >18 mmHg) | 85% | 409 eyes | 12-month follow-up milestone |
| Medication burden reduction | 40% mean | Full cohort | Long-term therapy benefit |
| Descemet’s membrane detachment | 0.3% (1 eye) | 600+ eyes | Self-resolving, no intervention required |
| Temporary hyphema (>10% anterior chamber) | 1.2% (5 eyes) | 600+ eyes | Self-resolving postoperative event |
The single reported Descemet’s membrane detachment, affecting 0.3% of eyes, resolved spontaneously without surgical intervention. Temporary hyphema (blood in the anterior chamber) occurred in 1.2% of cases, also self-resolving.
Both complication rates compare favourably to other MIGS procedures, positioning iTrack™ as a low-risk surgical option. The combination of strong efficacy (85% IOP reduction success) and minimal adverse events supports the durability narrative critical for market access.
Payors evaluating reimbursement decisions weigh long-term outcomes against complication risks, and this data strengthens Nova Eye’s competitive positioning against alternative MIGS devices.
Commercial pathway and what comes next
The 12-month follow-up milestone unlocks strategic opportunities beyond data collection. Surgeons contributing to the registry can now extract data for peer-reviewed journal publications, potentially accelerating broader surgical adoption as published evidence carries significant weight in medical communities.
Nova Eye Medical’s objectives for the registry align with commercial growth drivers:
- Surgeons can extract 12-month data for peer-reviewed publications
- Registry continues enrolling new surgical cases to expand evidence base
- Growing dataset supports payor and market access conversations globally
The company’s sales headquarters in Fremont, California, coordinates global distribution through regional partners. As the registry matures, this evidence base provides commercial teams with real-world data to support market access discussions, particularly in regions where payor scrutiny of new surgical technologies remains stringent.
Peer-reviewed publications emerging from this registry could accelerate surgeon training programmes and build confidence in the procedure’s reproducibility across different surgical settings. For investors, this represents a pathway to strengthening Nova Eye’s competitive moat in the MIGS market, where clinical differentiation drives adoption rates and market share gains.
The registry’s ongoing expansion, with new surgeons and sites joining, positions the company to build a robust long-term evidence base that extends beyond typical clinical trial endpoints.
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