Newly-published research in the American Academy of Ophthalmology’s peer-reviewed journal Ophthalmology Science presents promising 2-year data on the use of Iantrek, Inc.’s proprietary bio-interventional platform involving uveoscleral outflow technology among open-angle glaucoma (OAG) patients undergoing combined cataract surgery.
That’s a mouthful of an intro … break this all down for me.
We’ll start with Iantrek and its technology.
About the company: This venture-funded medical technology company specializes in micro- and bio-interventional eye surgery solutions for chronic ocular diseases.
The basis for this focus: A new bio-intervention surgical category stemming from a combination of natural allogeneic biotissues and high-precision micro-interventional technology.
- And its portfolio: Uveoscleral and trabecular minimally-invasive glaucoma surgery (MIGS) devices in varying stages of product development (including commercially available).
So tell me about this new approach.
As we previously reported on the company’s approach, Iantrek relies on scleral allograft tissues as a biocompatible and non-biodegradable material for reinforced and durable glaucoma surgical applications.
Most importantly: Current FDA-approved and commercially available variations of the ab-interno delivery technique typically only target one of the two major outflow pathways to the eye—the trabecular outflow pathway.
But didn't you just say that some of the devices in Iantrek's portfolio target the uveoscleral outflow pathway?
We did! Let’s give you some background on this …
Investigators have noted potential advantages associated with its larger outflow capacity, which could resolve the current need for a more efficacious form of glaucoma intervention that most trabecular outflow procedures lack.
Examples of those procedures: Goniotomy, canaloplasty, and trabecular microstents.
And what type of surgical procedure targets this pathway?
That would be cyclodialysis, a technique often used as an internal aqueous filtration channel to the suprachoroidal space.
A major advantage to this: It has been found to effectively lower intraocular pressure (IOP) in glaucoma patients.
- However: Investigators noted “its long-term efficacy and durability remain limited, particularly in those eyes with premature closure of the supraciliary filtration conduit.”
As such: Recent advancements in this area seek to provide a more “durable, biocompatible reinforcement” for cyclodialysis.
For example?
Bio-scaffolded cyclodialysis is one such approach for glaucoma treatment.
What this involves: The formation of a cyclodialysis cleft and lateral placement of cuboidal allograft spacers to “reinforce the central filtration channel” and enable better aqueous flow through the cleft.
- In other words: This technique uses a microinvasive approach to create a cyclodialysis pathway between the anterior chamber and suprachoroidal space that is reinforced with a bio-scaffold (allograft tissue) to lower IOP.
And this is where Iantrek’s technology comes in, right?
Yes—in the form of two of the company’s FDA-cleared and commercially-available devices.
First up: The CycloPen System is designed to deliver a proprietary, high-interventional cyclodialysis procedure with bio-reinforcement. See a visual of how it works—and previous research on it.
- A regulatory note: Iantrek initiated pre-commercial launch access to the system in 2024 to a select number of U.S. surgical centers, with a wider U.S. commercialization of the tech is planned for Q3 2025.
Second: The AlloFlow BioTissue is a bio-interventional solution intended for high-precision ab-interno homologous structural reinforcement.
- In the context of this study: It can be used to advance a cyclodialysis uveoscleral outflow channel, among other internal endoscleral structures. See here for a visual.
A key fact the company has emphasized: Iantrek is currently the only company with FDA-cleared technologies designed specifically for the surgical enhancement of the uveoscleral pathway.
Now to this research.
Investigators conducted a single-center, prospective case series on 31 consecutive surgeries involving the CycloPen System (bio-reinforced cyclodialysis with phacoemulsification).
- Participants: 31 eyes (aged 18+; 47% female) diagnosed with POAG and “visually significant” cataract
- Setup: Patients underwent the bio-scaffolded cyclodialysis procedure (via the CycloPen System) followed by scleral reinforcement (with the AlloFlo allogeneic bio-scaffold) in combination with cataract surgery.
- Duration: Participants were followed prospectively for 24 months
- Outcome measures:
- Primary: Eyes achieving ≥20% IOP reduction with same or less medications compared to baseline.
- Secondary: Mean change in medicated IOP and mean number of IOP lowering medications compared to baseline
- Plus: Adverse events (AEs) were evaluated and recorded throughout the study.
Now to the findings.
Here’s a highlights version:
- 74% of treated eyes achieved a ≥20% reduction in IOP at 2 years with the same or fewer glaucoma medications
- 34% reduction in mean medicated IOP was observed (from a baseline of 21.9 ± 4.9 mmHg to 13.84 ± 2.42 mmHg [p<0.0001])
- 96.8% and 80.6% of treated eyes achieved 24-month IOP ≤18mmHg and IOP ≤15mmHg, respectively
- >60% decrease in use of IOP-lowering medications was noted (based on an average of 1.42 ± 1.29 to 0.55 ± 0.52 at 2 years [p=0.0006])
As for AEs, no serious ocular AEs were reported—all complications that arose occurred within the first 3 to 6 months post-surgery and were “mild, transient, and resolved with conservative management.”
And how were visual acuity outcomes?
“Good,” according to the study authors.
The data: Visual acuity (VA) increased from an average baseline LogMAR best-corrected visual acuity (BCVA) of 0.70 ± 0.43 to 0.11 ± 0.11 at 24 months (p<0.0001; n=31 paired determinations)—which was expected with concurrent cataract surgery.
Now to the investigators’ thoughts.
The authors concluded that the study’s use of the CycloPen System when used with cataract surgery demonstrated “good IOP lowering and long-term durability,” with a significant and sustained IOP reduction and few ocular AEs or complications post-procedure.
And compared to conventional cyclodialysis: The procedure was noted as addressing key limitations “by incorporating a bio-reinforcement strategy aimed at improving the consistency and duration of the aqueous outflow.”
- Plus: The addition of a “bio-scaffolding cleft maintainer” led to a more predictable and reliable outcome than traditional cyclodialysis, according to the authors.
Any limitations to be aware of?
A few to keep in mind for future investigations. Among them:
- The need for a larger cohort for further determining efficacy and safety
- Need for an extended study period to determine durability beyond 2 years
- Uncontrolled design is not ideal, as it increased the susceptibility of the results to regression-to-the-mean bias
And overall?
The authors said it best: “With sustained IOP reduction, decreased medication reliance, and a favorable safety profile, this approach holds significant potential for broader clinical application.”