ViaLase treats first patient in U.S. trial of incision-free laser procedure for glaucoma

ViaLase Inc. has treated the first patient in its U.S. Investigational Device Exemption clinical trial evaluating a femtosecond laser trabeculotomy procedure for glaucoma, the company announced. The study will compare the company’s incision-free approach to selective laser trabeculoplasty (SLT), the current standard for lowering intraocular pressure (IOP).

The prospective, multicenter, randomized controlled trial was designed with the FDA and is intended to support eventual clearance and commercialization in the United States. If successful, it would represent one of the most rigorous evaluations to date of a non-incisional method to reduce IOP in glaucoma, a leading cause of irreversible blindness.

“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 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 which are safe, effective, and durable.”

Shawn O’Neil, CEO of ViaLase, said the company aims to build a new path for glaucoma care. “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,” he said. “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.”

Recent advances in glaucoma treatment technology

Glaucoma treatment has undergone significant evolution in recent years as device makers, clinicians, and researchers pursue safer, less invasive approaches to reducing IOP. While traditional surgical options such as trabeculectomy and tube shunts remain effective for advanced disease, many patients and clinicians are increasingly turning to technologies that aim to lower pressure in the eyes earlier and with fewer complications.

Minimally invasive glaucoma surgery has been one of the most transformative developments. Over the past decade, new implants, microstents, and canal-based procedures have expanded treatment choices for patients with mild to moderate disease who need more than eye drops but want interventions with faster recovery and lower risk than conventional surgery. These devices target the eye’s natural drainage pathways, offering pressure reduction without creating an external bleb or leaving large hardware behind.

Laser-based treatments are also advancing. SLT continues to gain traction as a first-line therapy thanks to its safety profile and repeatability, and researchers are now exploring next-generation lasers that target tissue with greater precision and potentially longer-lasting effect. Newer modalities are being designed to minimize thermal damage, automate energy delivery, and treat outflow resistance more directly.

Another major area of innovation is digital and diagnostic technology. High-resolution imaging, AI-assisted progression analysis, and home-based monitoring tools are giving physicians more precise ways to track IOP fluctuations and detect structural changes earlier. Some systems can integrate data from multiple devices to help clinicians tailor therapy and intervene before significant vision loss occurs.

Altogether, the push toward earlier intervention, lower-risk procedures, and more personalized management is reshaping glaucoma care. As novel technologies mature and clinical evidence accumulates, patients may increasingly benefit from treatment options that preserve vision while reducing reliance on long-term medications and invasive surgery.