ViaLase Announces First Patient Treated in IDE Clinical Trial Evaluating Its Femtosecond Laser Trabeculotomy for Open-Angle Glaucoma

Prospective, randomized controlled trial compares novel femtosecond laser procedure to selective laser trabeculoplasty (SLT), advancing path to US commercialization

ViaLase, Inc., a clinical-stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today 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.

“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.

About Glaucoma

Glaucoma affects 76 million people worldwide, a number that is expected to increase to 112 million by 2040, and is the second leading cause of irreversible blindness in the world.^1,2 Most forms of glaucoma are chronic and, when left undetected or untreated, lead to irreversible vision loss. Early detection and treatment are essential to protect against vision loss, which results when the optic nerve deteriorates, leading to progressive loss of the field of vision. Lowering IOP and thus reducing visual field progression is the only proven glaucoma treatment today. The current treatment paradigm typically begins with topical eye drops, then may advance to laser therapy or minimally invasive glaucoma surgery (MIGS), before resorting to invasive, traditional filtration surgery.

About ViaLase, Inc.

ViaLase, Inc. is a globally-minded, venture capital-backed, clinical stage medical technology company located in Aliso Viejo, CA. ViaLase is focused on disrupting the conventional glaucoma treatment paradigm with the introduction of a truly noninvasive, image-guided, femtosecond laser treatment that enhances glaucoma patient care. With a leadership team that has vast experience developing, designing, manufacturing, and commercializing the first femtosecond lasers for ophthalmic surgery for refractive and cataract patients, ViaLase is now bringing that expertise and innovation to glaucoma patients. ViaLase believes in collaborating closely with health care providers, payers, societies, and patients to inform our product development and commercial activities with the goal of bringing this revolutionary treatment to glaucoma patients across the globe. For more information, visit www.ViaLase.com.

References

1. 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
2. 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

Any product/brand names and/or logos are trademarks of ViaLase, Inc.

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