ViaLase receives CE mark for first femtosecond laser for treatment of glaucoma

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ViaLase Inc 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). 

According to a news release, the 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. 

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

The company noted the technology addresses an unmet need for patients who may benefit from a non-pharmacologic, incision-free procedure without compromising their therapeutic goals.

The laser currently is not approved for use in the United States.

Tibor Juhasz, PhD, founder and CEO of ViaLase, noted in the news release the laser represents a shift 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.

“Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure (IOP),” he said in a statement. “We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe.”

Richard Lewis, MD, the company’s chief medical officer, pointed out that there is 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,” he said in a statement. “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.”

According to the company, it anticipates a selective commercial rollout of the laser in key markets later this year. The company noted in the news release that it also has established formal distributor partnerships with Global Surgical Service (Spain and Portugal) and Teleon Surgical (Germany and Austria).

Both companies have experience in ophthalmology and are established in their markets. These strategic partnerships will allow for a timely and efficient rollout of the laser to physicians and patients, according to the news release.

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/S01616420140