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Rick Lewis, chief medical officer of ViaLase, describes the company's nonincisional glaucoma treatment, showing promising safety and efficacy in studies and possibly paving the way for FDA approval.
Rick Lewis, chief medical officer of ViaLase, describes the company's nonincisional glaucoma treatment, showing promising safety and efficacy in studies and possibly paving the way for FDA approval.
Editor’s note - The following transcript has been lightly edited for clarity.
Rick Lewis, MD: Hi, I'm Rick Lewis. I'm the chief medical officer for ViaLase. ViaLase is a startup surgical company that is trying to treat glaucoma by creating a channel of 500 microns wide in the trabecular meshwork. We use a nonincisional technique to provide outstanding imaging using gonioscopic image as well as OCT to visualize the trabecular meshwork. When we do this correctly, we can place a channel, 500 by 200 microns, almost anywhere in the meshwork for 360 degrees.
We have shown in a safety study this is a safe and effective treatment. 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. A single channel of 500 by 200 microns was sufficient to control pressure.
We've carried this information forward. We now have a pivotal trial in which we've enrolled all the patients. We have a study that was designed to randomize between the femtolaser treatment and an SLT—152 total patients; 76 in each group.
We're looking at these patients to determine again both efficacy and safety. We should have data collected in the 6-month follow-up sometime next month. We hope to lock the database and file with the FDA later this year. Our results so far, again, indicating good safety and good efficacy and we're excited by this technology because it's a nonincisional approach to treating glaucoma.