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

The prospective, multicenter, randomized, controlled trial compares the ViaLase procedure to selective laser trabeculoplasty (SLT), the current standard laser treatment used to reduce IOP. Designed in consultation with the FDA, the pivotal IDE trial is structured to support future regulatory clearance and commercialization in the United States. 

“Treating the first patient in this trial is a significant milestone, not only for ViaLase, but for the broader glaucoma community,” said Thomas W. Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants and medical monitor of the ViaLase pivotal trial. “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.”

ViaLase’s femtosecond laser trabeculotomy procedure is designed to deliver precise, noninvasive treatment to the eye’s natural drainage pathway, potentially offering glaucoma patients a safer, less invasive alternative to current surgical and laser-based approaches.

“Our mission at ViaLase is to develop a new approach to manage IOP in patients with glaucoma,” said Shawn O’Neil, chief executive officer of ViaLase. “This IDE trial is an important step toward making the ViaLase procedure broadly available to the millions of glaucoma patients in need. We believe our technology has the potential to begin an entirely new era in glaucoma care—one where precision, safety, and the patient experience define the standard of treatment.”