ViaLase, Inc announced that the first patient has been treated in its investigational device exemption (IDE) clinical trial evaluating the company’s femtosecond laser trabeculotomy procedure for the management of glaucoma.

This prospective, multicenter, randomized, controlled trial evaluates the ViaLase procedure in comparison to selective laser trabeculoplasty (SLT). This trial was designed in consultation with the US Food and Drug Administration (FDA) to achieve clearance and commercialization in the United States, the company said in a press release.

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

Shawn O’Neil, chief executive officer of ViaLase, added, “Our mission at ViaLase is to develop a new approach to manage IOP in patients with glaucoma. 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.”

The ViaLase Laser is approved for use in Europe, receiving CE Mark in July 2024 for treatment of adults with primary open-angle glaucoma.