Key Takeaways
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Bio-reinforced canaloplasty combined with cataract surgery produced a 37.2% mean IOP reduction and a 49.1% decrease in glaucoma medication use at 6 months in 52 eyes
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No serious ocular adverse events or secondary IOP-lowering surgeries were reported through 6 months, while 2 upcoming AAO 2026 presentations will examine bio-reinforced cyclodialysis outcomes
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Iantrek is continuing the BOOST clinical study of AlloSpan Canal and anticipates commercial introduction in 2027, pending further clinical and development milestones.
Iantrek has announced topline 6-month results from a first-in-human, investigator-initiated study evaluating bio-reinforced canaloplasty in combination with cataract surgery, reporting a 37.2% reduction in mean IOP and a 49.1% reduction in glaucoma medication use.
The findings, involving 52 treated eyes, provide early clinical evidence supporting the company's bio-interventional ophthalmic surgery (BIOS) approach to the trabecular outflow pathway. The company is also preparing to present additional data on bio-reinforced cyclodialysis targeting the uveoscleral outflow pathway at the 2026 American Academy of Ophthalmology (AAO) annual meeting, October 9-12, in New Orleans.
According to Iantrek, mean IOP decreased 37.2% from a baseline of 22.4 mmHg at 6 months following bio-reinforced canaloplasty combined with cataract surgery. Additionally, 90% of treated eyes achieved an IOP of 18 mmHg or lower. Mean glaucoma medication use decreased 49.1% from a baseline of 1.2 medications.
The company reported no serious ocular adverse events, and no eyes required secondary surgical intervention for IOP control during the 6-month follow-up period.
"With more than 10,000 bio-reinforced cyclodialysis procedures now performed in the US to enhance uveoscleral outflow, we're excited to bring that same restorative, natural approach to the complementary outflow pathway with bio-reinforced canaloplasty," said Adam Szaronos, chief executive officer of Iantrek. "These early results support our belief in a simple concept: pairing established surgical interventions with homologous tissue to help surgeons restore and reinforce the eye's natural outflow pathways. That is the foundation of bio-interventional ophthalmic surgery."
CREST study findings to be presented at AAO
In addition to the canaloplasty findings, Iantrek will present 2 analyses from the CREST study evaluating cyclodialysis with allograft scleral reinforcement.
The presentations will address surgical outcomes and ocular safety across more than 500 cases, as well as 1-year IOP outcomes associated with the use of 1 versus 2 allograft spacers.
Reena Garg, MD, will present "Surgical Outcomes, Ocular Safety and Tolerability of Bio-Interventional Cyclodialysis With Allograft Scleral Reinforcement: Clinical Experience of More Than 500 Cases." The analysis, coauthored by Jason Bacharach, MD, is scheduled for Sunday, October 11, at 3:30 p.m. in the Poster Theater, Hall C, as part of session PO074.
A second presentation, "One-Year IOP Dose-Response Results of 1 vs. 2 Bio-Interventional Allograft Spacers Following Ab Interno Cyclodialysis in Combination With Cataract Surgery," will be available on demand. Doug McGraw, DO, will present the findings as part of session PO412.
Together, the analyses are expected to provide additional information about the clinical performance of bio-reinforced cyclodialysis, including procedural safety and the potential relationship between the number of allograft spacers and postoperative IOP outcomes.
Iantrek's BIOS platform is designed to reinforce the eye's natural aqueous humor outflow pathways through the incorporation of homologous allograft tissue into established glaucoma surgical techniques.
The company's bio-reinforced cyclodialysis approach targets the uveoscleral outflow pathway, while its bio-reinforced canaloplasty procedure, AlloSpan Canal, targets the trabecular outflow pathway.
According to Iantrek, approximately 3.5 million eyes in the United States have previously undergone minimally invasive glaucoma surgery (MIGS), representing a potentially substantial population requiring additional treatment as glaucoma progresses. The company also estimates that approximately 400,000 canal-based procedures are performed annually.
Iantrek is continuing to evaluate AlloSpan Canal through the ongoing BOOST clinical study at select US sites.
The procedure combines canal dilation with internal structural reinforcement using homologous allograft tissue. According to the company, this approach is intended to extend the principles of bio-interventional ophthalmic surgery to the conventional trabecular outflow pathway.
Iantrek stated that the procedure is reported under the established Category I Current Procedural Terminology (CPT) code 66175. The company also noted that AAO issued reimbursement guidance related to the procedure earlier in 2026.
Iantrek anticipates introducing AlloSpan commercially in 2027. Additional BOOST study findings, extended follow-up from the initial canaloplasty cohort, and further CREST analyses are expected to contribute to the evidence base for the company's bio-interventional glaucoma surgery portfolio.