The AlloFlo^™ Uveo

At Iantrek, our mission is to empower surgeons with breakthrough innovations targeting unmet needs in chronic eye disease. Of the eye’s two natural aqueous outflow pathways—trabecular and uveoscleral—surgeons have numerous options for enhancing the trabecular route, but have had zero options for surgical enhancement of the uveoscleral pathway, despite its significant advantage of pressure-independent outflow.

The uveoscleral pathway has always held immense therapeutic promise, but surgically accessing this pathway has proven challenging. That barrier is not a problem of anatomy, but from the limits of material science.

Our founder, Sean Ianchulev, MD, MPH—who helped pioneer earlier MIGS technologies—identified the opportunity that tissue-based products, which are regularly used for patch grafts in glaucoma surgery, could provide. Bio-spacers crafted from minimally-manipulated donor scleral tissue could be used to reinforce and maintain the patency of a cyclodialysis cleft to reliably enhance outflow. This insight led to the creation of the AlloFlo™ Uveo: the first bio-interventional technology in surgical glaucoma.

A New Category in Interventional Glaucoma

Unlocking the uveoscleral pathway creates another option for surgeons and a new, complementary surgical approach targeting a massive unmet need. While trabecular-based MIGS has improved outcomes over the past two decades, there are currently 2.5 million pseudophakic post- MIGS eyes in the U.S. experiencing waning efficacy, with 350,000 more added each year.¹ These post-MIGS eyes are destined on a path toward increasing medications and bleb-forming procedures. The ability to unlock the uveoscleral pathway in a minimally-invasive fashion changes this. Our bio-interventional technology allows surgeons to further enhance the eye’s natural outflow pathways while staying in the angle.

Surgical Innovations

AlloFlo Uveo bio-tissue is a sterile 500 µm x 5 mm rectangular Bio-Spacer made from donor scleral tissue, which is pre-loaded into a cannula that fits onto the AlloSert Uveo handpiece. After creation of a controlled cyclodialysis to enhance aqueous outflow, the surgeon positions AlloFlo Uveo inside the cleft to provide durable reinforcement (Figure).

The learning curve associated with this procedure is minimal, requiring only a few cases to gain confidence using the products. Often, surgeons find the bio-tissue implantation to be more intuitive than standard MIGS for two reasons: The “landing zone” in the trabecular canal has a tolerance of microns, whereas the uveoscleral space is one of millimeters. Additionally, the bio-tissue’s malleable properties allow for controlled adjustments and final positioning.

Clinical Efficacy

To date, the AlloFlo Uveo has been used in over 3,000 procedures in the U.S.—more than 60% as standalone surgeries. Our CREST study includes over 450 procedures, making it one of the largest interventional glaucoma studies conducted. Enrollment in CREST will continue through year-end, with over 500 procedures expected.

Interim data from 2-year follow-up indicates that patients maintain mean IOP reduction greater than 30%; no serious product-related adverse events have been reported; and the rate of endothelial cell loss (ECL) is similar to that of control groups in studies of MIGS stents used in combination with cataract surgery.²

Interim 1-year³ and 2-year data² from the CREST trials have been published, and we look forward to publishing long-term data out to 5 years.

What’s Next?

More than 3,000 procedures have been commercially reimbursed in our early rollout as we build sales and support infrastructure. We’re now preparing for full commercial launch at the 2025 AAO meeting, with European expansion planned in the coming years. Our next-generation bio-tissue implant has completed first-in-human trials and is slated for launch in 2026.

1. Data on file, Iantrek, Inc.

2. Calvo E, et al. Opthalmol Science. 2025;5(4):100727. doi: 10.1016/j.xops.2025.100727

3. Ianchulev T, et al. Clin Ophthalmol. 202418:3605–3614. doi: 10.2147/OPTH.S496631

https://iantrekmed.com

Inquiries: aszaronos@Iantrekmed.com