ViaLase Starts U.S. Trial for Incision-Free Glaucoma Laser

ViaLase has announced the treatment of the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial, marking a major milestone in the development of its femtosecond laser trabeculotomy procedure, a novel, incision-free approach for the treatment of glaucoma.

Evaluating a New Laser-Based Alternative to SLT

The prospective, multicenter, randomized, controlled trial is designed to compare the ViaLase procedure with selective laser trabeculoplasty (SLT), which is currently the standard laser therapy for reducing intraocular pressure (IOP) in glaucoma patients. Developed in consultation with the U.S. Food and Drug Administration (FDA), the pivotal IDE trial is structured to support future regulatory clearance and commercialization in the United States.

Clinical Significance and Potential Impact

Thomas W. Samuelson, MD, founding partner and attending surgeon at Minnesota Eye Consultants and medical monitor of the trial, emphasized the importance of this milestone:

“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.”

Precision-Based, Noninvasive Approach to Glaucoma Management

ViaLase’s femtosecond laser trabeculotomy is designed to target the eye’s natural drainage pathway with a precise, noninvasive laser, aiming to lower IOP without surgical incisions. This innovative approach may offer a safer and less invasive alternative to existing glaucoma treatments, aligning with current trends toward non-pharmacologic, minimally invasive therapies.

Strategic Vision for the Future of Glaucoma Treatment

Shawn O’Neil, CEO of ViaLase, commented on the significance of the IDE trial as part of the company’s broader mission:

“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.”