US-based medical technology company ViaLase has secured the CE Mark approval for its ViaLase Laser to treat adult patients with primary open-angle glaucoma (POAG).
The ViaLase Laser is designed to deliver a noninvasive glaucoma treatment, dubbed femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT).
FLigHT combines the precision of a femtosecond laser and the accuracy of micron-level image guidance.
Its ViaLase Laser technology will address a major unmet need for patients who may benefit from a non-pharmacologic, incision-free procedure, said the medical technology company.
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). We look forward to working with our distribution partners to bring this groundbreaking technology to physicians and patients in Europe.”
ViaLase is planning for a limited rollout of its laser system in key markets, later this year.
The company has signed distribution partnerships with Global Surgical Service in Spain and Portugal, and Teleon Surgical in Germany and Austria.
Both Global Surgical Service and Teleon Surgical have extensive experience in ophthalmology and established commercial presence in their markets.
The strategic partnerships will facilitate a timely and effective roll-out of its ViaLase Laser to physicians and patients, said the US medical technology company.
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.”
