Iantrek reports publication of positive 2-year results from a clinical study evaluating its bio-reinforced cyclodialysis technology for open-angle glaucoma (OAG) patients undergoing cataract surgery. Published in Ophthalmology Science, the data demonstrate the technology’s long-term effectiveness and safety in enhancing uveoscleral outflow to lower intraocular pressure (IOP).
The study found that 74% of treated eyes achieved at least a 20% reduction in IOP, with a significant decrease in the use of glaucoma medications. Mean medicated IOP dropped from 21.9 mmHg to 13.8 mmHg, and medication usage decreased by over 60%. No serious adverse events were reported, with complications being mild and transient.
“It is great to see our clinical intuition validated with long term clinical results ... and the new reincarnation of one of the oldest ab interno glaucoma procedures, cyclodialysis, now modernized and reimagined through Iantrek’s bio-interventional platform technology … so that surgeons can intervene in the uveoscleral outflow not only pharmacologically, but surgically as well,” said Sean Ianchulev, MD, Iantrek’s founder and chairman of the board.
The bioreinforced cyclodialysis procedure uses Iantrek’s CycloPen system to create a cyclodialysis cleft between the anterior chamber and the suprachoroidal space. The device then places biocompatible allograft tissue called AlloFlo to help keep the drainage pathway open. Currently, there are no other FDA-approved devices that target the uveoscleral pathway. The company reports that it will begin broader commercialization of the CycloPen in the third quarter of 2025.
The study results align with findings from a recent scientific presentation at the American Glaucoma Society's annual meeting, where Dr. Leon W. Herndon of Duke University presented similar positive outcomes for the procedure, confirming that the minimally invasive approach offers sustained IOP reduction and a favorable safety profile. GP