ViaLase Laser receives CE Mark, announces first EU distribution partners
Femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) received approval for patients in Europe with primary open-angle glaucoma
ViaLase projects a selective commercial rollout of the ViaLase Laser in key markets during the remaining months of 2024. Image credit: ©monsifdx – stock.adobe.com
ViaLase, Inc., announced on Tuesday it has received CE Mark approval in the European Union for its ViaLase Laser for the treatment of adult patients with primary open-angle glaucoma (POAG). The novel procedure is called femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT). According to a press release1 from ViaLase, FLigHT is a suitable solution for patients with POAG who are seeking a non-pharmacologic and incision-free glaucoma intervention.
Following issuance of the CE Mark, ViaLase projects a selective commercial rollout of the ViaLase Laser in key markets by early 2025. In Spain and Portugal, ViaLase has established formal distributor partnerships with Global Surgical Service; in Germany and Austria, the company has partnered with distributor Teleon Surgical.
According to the World Health Organisation, glaucoma is the second leading cause of irreversible blindness, affecting 76 million patients annually. That number is expected to increase to 112 people worldwide by 2040.2 Richard Lewis, MD, Chief Medical Officer at ViaLase, described the ViaLase Laser and FLigHT procedure, specifically detailing how they can serve the continually-growing global population of patients with glaucoma.1
“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,” Dr Lewis said in the press release. “The patient’s lens status has no bearing on their ability to undergo FLigHT, expanding access to patients who previously had limited treatment options.”
ViaLase released safety and efficacy data from an initial pilot study of the FLigHT procedure last April. At the 2023 American Academy of Ophthalmology meeting, Dr Lewis spoke with Ophthalmology Times, detailing the pivotal trial VIA-002, a randomised prospective trial of the ViaLase Laser versus SLT for treating POAG in adult patients.
At this year’s American Society of Cataract and Refractive Surgeons, Dr Lewis went into detail on the way FLigHT functions. “[The procedure treats] glaucoma by creating a channel of 500µm wide in the trabecular meshwork,” he detailed.3 “We use a nonincisional technique to provide outstanding imaging using gonioscopic image as well as OCT to visualise the trabecular meshwork. When we do this correctly, we can place a channel, 500µm by 200µm, almost anywhere in the meshwork for 360 degrees.”
“We have shown in a safety study this is a safe and effective treatment,” Dr Lewis continued. “In that study, we carried out to patients out to 3 years. We have 18 eyes of 12 patients, looking at how they did in terms of other IOP and other kinds of side effects. They did very well without any adverse events. The intraocular pressure was dropped down into the low teens. Patients have done quite well, and this demonstrated to us this durability of this procedure.”
Tibor Juhasz, PhD, founder and Chief Executive Officer of ViaLase, also issued a statement in the press release.1 “Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure,” he said. “We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe.”
The ViaLase Laser has not yet received FDA approval for use in the US. ViaLase is based in Aliso Viejo, California, and is a clinical-stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm.
References
ViaLase Receives CE Mark for First Femtosecond Laser for the Treatment of Glaucoma, the ViaLase® Laser. Press release. ViaLase, Inc. Accessed 29 July, 2024.
World Health Organization. World report on vision: Executive Summary 2019. Published 8 October, 2019. Accessed 29 July, 2024. https://iris.who.int/bitstream/handle/10665/328721/WHO-NMH-NVI-19.12-eng.pdf
Stevenson S, Hayes H. ASCRS 2024: An update from ViaLase on its technology for a nonincisional approach to treating glaucoma. Ophthalmology Times. Published 29 April, 2024. Accessed 29 July, 2024. https://www.ophthalmologytimes.com/view/ascrs-2024-an-update-from-vialase-on-its-technology-for-a-nonincisional-approach-to-treating-glaucoma-
