First patient treated in ViaLase’s IDE trial

ViaLase announced the first patient has been treated in its US-based Investigational Device Exemption (IDE) clinical trial evaluating the company’s femtosecond laser trabeculotomy procedure for the management of glaucoma.¹

The ViaLase laser procedure delivers precise femtosecond laser pulses, guided by micron-accurate imaging, to create apertures through the trabecular meshwork (TM) and into Schlemm’s canal.²

The IDE trial is a prospective, multicenter, randomized, controlled trial evaluating ViaLase’s procedure in comparison to selective laser trabeculoplasty (SLT). The company notes that the trial was designed in consultation with the FDA to achieve clearance and commercialization in the US and thus represents one of the “most rigorous evaluations” of an incision-free approach to reduce IOP.

Thomas W Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants, and medical monitor of the ViaLase pivotal trial, commented in a press release from the company, saying, “Treating the first patient in this trial is a significant milestone, not only for ViaLase, but for the broader glaucoma community. For the first time, we will have randomized data comparing a next-generation incision-free canal procedure against SLT. The results have the potential to reshape the glaucoma treatment paradigm as physicians and patients are increasingly seeking incision-free, non-pharmacologic pressure-lowering therapies that are safe, effective, and durable.”

At the end of 2024,² ViaLase announced a research partnership with the John A. Moran Eye Center at the University of Utah, home to the Alan S. Crandall Center for Glaucoma Innovation, to investigate the aqueous outflow dynamics of ViaLase’s novel laser procedure, using Moran's advanced iPerfusion technology.

References:

1. ViaLase Announces First Patient Treated in IDE Clinical Trial Evaluating Its Femtosecond Laser Trabeculotomy for Open-Angle Glaucoma. Published December 3, 2025. Accessed December 3, 2025. https://www.businesswire.com/news/home/20251203052005/en/ViaLase-Announces-First-Patient-Treated-in-IDE-Clinical-Trial-Evaluating-Its-Femtosecond-Laser-Trabeculotomy-for-Open-Angle-Glaucoma

2. Hutton D. ViaLase, John A. Moran Eye Center unveil research partnership to spark glaucoma research, innovation. Published December 11, 2024. Accessed December 3, 2025. https://mjh.sanity.studio/ophtalmology/structure/article;3a699e96-a227-4572-86d4-9068fa7fc4b4%2Ctemplate%3Darticle