ViaLase, a clinical-stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, announced that the first patient has been treated in its U.S. Investigational Device Exemption (IDE) clinical trial evaluating the company’s femtosecond laser trabeculotomy procedure for the management of glaucoma, a lifelong, progressive, and incurable disease that remains a leading cause of irreversible blindness worldwide.
This prospective, multicenter, randomized, controlled trial evaluates the ViaLase procedure in comparison to selective laser trabeculoplasty (SLT), the current standard laser treatment for reducing intraocular pressure (IOP). This trial was designed in consultation with the FDA to achieve clearance and commercialization in the U.S. and thus represents one of the most rigorous evaluations of an incision-free approach to reduce IOP.
A Paradigm Shift in Glaucoma Treatment
“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, 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 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.”
Caution: The Vialase Laser System is an investigational device, limited by United States law to investigational use.
References
- World Health Organization. World report on vision: Executive Summary 2019. https://iris.who.int/bitstream/handle/10665/328721/WHO-NMH-NVI-19.12-eng.pdf
- Tham YC, Xiang L, et al. Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040: A Systematic Review and Meta-Analysis. Ophthalmology 2014; 121(11): 2081-2090. https://www.sciencedirect.com/science/article/abs/pii/S0161642014004333
