Iantrek Publishes 12-Month Results for its Bio-Interventional Uveoscleral Outflow Technology

Iantrek has announced 1-year results for the first 100 eyes enrolled in the CREST Registry, a real-world, prospective, observational study evaluating bio-interventional procedures in patients with open-angle glaucoma (OAG). The findings, published in the journal Clinical Ophthalmology, underscore the safety and effectiveness of a novel approach using the CycloPen System in conjunction with AlloFlo Bio-Tissue implantation.

According to Iantrek, the study, titled "One-Year Safety and Effectiveness of Bio-Interventional Cyclodialysis and Scleral Reinforcement in Open-Angle Glaucoma Patients," represents the largest dataset of its kind, showcasing the potential of surgical micro-instrumentation paired with allogeneic bio-tissue to improve aqueous outflow and lower IOP.

Key Findings

• IOP Reduction: For patients with baseline IOP > 21 mmHg, a 39.7% reduction in mean IOP was observed at the 12-month mark.
• Medication Reduction: The average number of IOP-lowering medications dropped from 1.4 ± 1.3 to 0.8 ± 0.9, with 81.9% of patients achieving an IOP of ≤18 mmHg without additional medications.
• Safety: The procedure demonstrated a robust safety profile, with no vision-threatening adverse events. Only 3.2% of patients required secondary glaucoma surgery to achieve target IOP.

The procedure employs a two-pronged approach: creating an internal cyclodialysis channel to enhance uveoscleral outflow—a natural drainage pathway—and reinforcing it with homologous allogeneic scleral tissue for long-term durability. This technique eliminates the need for implantable synthetic devices, using a 100% biologic acellular collagen matrix instead.

The CycloPen System combined with AlloFlo Bio-Tissue represents a transformative leap in glaucoma management. 

The study was led by an esteemed group of international ophthalmology experts:

• Tsontcho Ianchulev, MD – New York Eye and Ear of Mount Sinai, New York, NY; Founder of Iantrek, Inc.
• Robert N. Weinreb, MD – Shiley Eye Institute, University of California San Diego, La Jolla, CA
• Ernesto A. Calvo, MD – Clínica de Ojos Orillac-Calvo, Panama City, Panama
• James Lewis, MD – Cataract Philadelphia, Elkins Park, PA
• Gautam Kamthan, MD – New York Eye and Ear of Mount Sinai, New York, NY
• Arsham Sheybani, MD – Washington University School of Medicine, St. Louis, MO
• Douglas J. Rhee, MD – University Hospitals, Case Western Reserve University, Cleveland, OH
• Iqbal K. Ahmed, MD – John Moran Eye Center, University of Utah, Salt Lake City, UT