MetaMedical™ Solutions Inc

Patient enrolment completes in ViaLase Laser pivotal trial

ViaLase has concluded the enrolment of adult patients in the VIA-002 pivotal trial for the treatment of primary open-angle glaucoma (POAG) using the ViaLase Laser.

The ViaLase Laser integrates femtosecond laser technology, precision and micron-level image guidance accuracy for delivering a noninvasive glaucoma treatment known as femtosecond laser image-guided high-precision trabeculotomy (FLigHT).

The randomised, controlled, prospective and multi-centre study is designed to compare the use of the ViaLase Laser against selective laser trabeculoplasty (SLT) in adult patients with POAG.

In the trial, 152 patients have been randomised to either the SLT or ViaLase Laser.

A reduction in mean unmedicated intraocular pressure (IOP) from baseline to six months and 12 months is the primary effectiveness endpoint of the trial.

The percentage of eyes with a >20% reduction in unmedicated IOP at the same period with no secondary surgical intervention for glaucoma treatment is one of the secondary effectiveness endpoints.

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A reduction in the mean number of hypotensive medications from screening to six months and 12 months is the other secondary effectiveness endpoint.

ViaLase founder and CEO Tibor Juhasz said: “We are optimistic that our pivotal trial will demonstrate the safety and efficacy of the first-ever FLigHT treatment performed by the ViaLase Laser.

“Ultimately, it is our greatest wish to be able to provide an effective, noninvasive treatment to the millions of people living with glaucoma, one of the leading causes of irreversible blindness worldwide.”

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