ViaLase receives CE mark for laser glaucoma treatment

01 Aug 2024

Company is preparing its femtosecond platform for European commercialization.

California-based medical technology startup ViaLase has announced that its ViaLase Laser device for glaucoma treatment has received CE mark approval.

The approval moves the platform towards commercialization in select European markets later in 2024. The device is not currently approved for US use.

Earlier in 2024 ViaLase secured $40 million in additional Series C funding for continued advancement of clinical, regulatory, and commercial milestones of the ultrafast laser approach to glaucoma therapy.

Announcing that funding, ViaLase said that its platform will be the first femtosecond laser used for the treatment of primary open angle glaucoma, one form of the eye disease which is expected to affect 112 million people by 2040.

Femtosecond laser treatment has become an established part of cataract surgery, facilitating lens removal and replacement with as small an incision as possible for greater patient safety and comfort.

Glaucoma surgery, however, has often involved more invasive argon laser trabeculoplasty to manipulate the drainage channels within the eye and reduce the high fluid pressure causing the condition.

ViaLase has designed its device to use femtosecond laser pulses to do the job instead, creating a precise, customized drainage channel through the eye's trabecular meshwork and increasing aqueous outflow without opening up the eye. It has described this approach as minimally invasive, rather than non-invasive.

The procedure 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," commented the company.

"This technology addresses a major unmet need for patients who may benefit from a non-pharmacologic, incision-free procedure without compromising their therapeutic goals."

Monumental transformation in glaucoma care

FLigHT's femtosecond pulses create a 500 x 200-micron channel in the trabecular meshwork, after which OCT imaging allows the clinician to visualize sub-surface tissue structures relative to the location of the channel and document those imaging findings, according to company literature.

An initial in-human clinical study of 11 subjects completed in April 2023 indicated that FLigHT achieved a mean lowering of the critical intraocular pressure by over 34 percent at 24 months after treatment, without serious adverse effects.

In October 2023 ViaLase completed enrollment for a larger and pivotal clinical trial, which will include 152 patients and compare FLigHT with conventional selective laser trabeculoplasty (SLT) glaucoma treatment.

"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, ViaLase founder and CEO.

"Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure. We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe."