Iantrek, Inc. announces 1-Year outcomes from the CREST Registry for bio-interventional glaucoma treatment

(Image credit: Adobe Stock/Yurii Kibalnik)

Iantrek, Inc. has released 1-year follow-up data from the first 100 eyes enrolled in the CREST Registry, a prospective, real-world observational study assessing the outcomes of bio-interventional procedures for patients with open-angle glaucoma (OAG).

The study, titled "One-Year Safety and Effectiveness of Bio-Interventional Cyclodialysis and Scleral Reinforcement in Open-Angle Glaucoma Patients," was recently published in Clinical Ophthalmology. It provides valuable insights into the safety and efficacy of micro-invasive cyclodialysis cleft formation using the CycloPen System, followed by scleral reinforcement with AlloFlo Bio-Tissue implantation.

The CREST Registry is the largest study to date to report long-term results from this innovative approach, which utilizes surgical micro-instrumentation and allogeneic bio-tissue to enhance aqueous outflow and reduce intraocular pressure (IOP). This bio-interventional technique aims to improve uveoscleral outflow—1 of the eye's 2 natural drainage pathways—by creating an internal cyclodialysis channel, which is then bio-reinforced to ensure long-term patency.

This new method offers a potential breakthrough for managing OAG, a condition that affects more than 80 million people globally.

Key findings

• IOP Reduction: For patients with a baseline IOP greater than 21 mmHg, the 12-month mean IOP decreased by 39.7%.
• Medication Reduction: By 12 months postoperatively, the average number of IOP-lowering medications fell from 1.4 ± 1.3 to 0.8 ± 0.9. Notably, 81.9% of patients achieved an IOP of ≤18 mmHg without requiring additional medication.
• Safety Profile: The procedure demonstrated a favorable safety profile, with a low rate of postoperative complications. Importantly, no vision-threatening adverse events were reported, and only 3.2% of patients required secondary glaucoma surgery within the 12-month follow-up period to achieve target IOP.

The study highlights the use of minimally modified allogeneic scleral tissue as a bio-scaffold for reinforcing the cyclodialysis cleft, improving the durability and effectiveness of the procedure. In contrast to implantable metal stents or shunts, the scleral allograft bio-tissue is a natural, homologous material made from 100% biologic acellular collagen. This bio-tissue is specifically prepared and packaged for use in bio-scaffolding and internal structural reinforcement.

Clinical implications

The CycloPen System combined with AlloFlo Bio-Tissue represents a significant advancement in glaucoma surgery. By enhancing uveoscleral outflow, this technique offers a promising alternative for patients requiring IOP reduction. With its strong safety profile and encouraging results, this approach has the potential to become a valuable tool in managing OAG, one of the leading causes of blindness worldwide.

This study underscores the potential for bio-interventional procedures to provide safer, more effective solutions for patients with open-angle glaucoma, paving the way for future advancements in glaucoma management.