ViaLase Receives CE Mark for First Femtosecond Laser for the Treatment of Glaucoma, the ViaLase® Laser

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The ViaLase Laser combines state-of-the-art femtosecond laser technology with micron-level image guidance to deliver the first femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT), marking a pioneering advancement in glaucoma care

ViaLase is pleased to announce strategic distribution partnerships with Teleon and
Global Surgical Service in preparation for commercialization in select European markets

ALISO VIEJO, Calif., July 30, 2024 /PRNewswire/ -- ViaLase, Inc., a clinical-stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm, today announced that it has received CE (Conformité Européenne) Mark approval in the European Union (EU) for its ViaLase^® Laser* for the treatment of adult patients with primary open-angle glaucoma (POAG). 

The ViaLase Laser combines the precision of a femtosecond laser and the accuracy of micron-level image guidance to deliver a noninvasive glaucoma treatment called femtosecond laser, image-guided, high-precision trabeculotomy, or FLigHT. This technology addresses a major unmet need for patients who may benefit from a non-pharmacologic, incision-free procedure without compromising their therapeutic goals.

"The ViaLase Laser represents a monumental transformation in interventional glaucoma care in its potential to deliver surgery-like results without the need for opening the eye and thus, reducing complications associated with more invasive, surgical procedures," said Tibor Juhasz, PhD, Founder and Chief Executive Officer, ViaLase, Inc. "Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure (IOP). We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe."

"We have good evidence that early, non-medical intervention offers better long-term disease control and preservation of vision – which is what matters most to patients. I'm delighted that physicians and patients can soon benefit from the ViaLase Laser, which brings a new level of imaging and precision to glaucoma care. Furthermore, the patient's lens status has no bearing on their ability to undergo FLigHT, expanding access to patients who previously had limited treatment options," said Richard Lewis, MD, Chief Medical Officer, ViaLase, Inc.

ViaLase anticipates a selective commercial rollout of the ViaLase Laser in key markets later this year. The company has established formal distributor partnerships with Global Surgical Service (Spain and Portugal) and Teleon Surgical (Germany and Austria). Each organization has deep ophthalmology experience and an established commercial presence in their markets. These strategic partnerships will allow for a timely and efficient rollout of the ViaLase Laser to physicians and patients.

*The ViaLase Laser is not approved for use in the United States.

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 protecting 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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