ViaLase, a clinical-stage medical technology company, has secured CE Mark approval for its first femtosecond laser to treat glaucoma, in the European Union.

The ViaLase Laser is designed to treat adult patients with primary open-angle glaucoma (POAG) using a non-invasive procedure known as femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT).

It represents a significant advancement in glaucoma treatment, combining the precision of a femtosecond laser with micron-level image guidance.

This technology offers a non-pharmacologic, incision-free procedure while retaining the therapeutic goals.

ViaLase is preparing for a selective commercial rollout of the ViaLase Laser in key European markets later in the year.

In October 2023, ViaLase concluded the enrolment of adult patients in the VIA-002 pivotal trial for the treatment of POAG using the ViaLase Laser.

ViaLase founder and CEO Tibor Juhasz said: “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.

“Early clinical data indicate that FLigHT is safe and effective at lowering intraocular pressure (IOP).”

The company partnered with Global Surgical Service for distribution in Spain and Portugal, as well as with Teleon Surgical for Germany and Austria.

ViaLase chief medical officer Richard Lewis said: “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.”