ASCRS Live: FDA clinical trial results for StableVisc

Ophthalmology Times® spoke with Mitch Shultz, MD at ASCRS 2023 in San Diego about the a new FDA clinical trial for a device called StableVisc being launched on the market by Bausch + Lomb.

Video transcript

Editor’s note: Transcript lightly edited for clarity.

Mitchell C. Shultz, MD:

Hi, I'm Dr. Mitch Shultz at Shultz Chang Vision in Los Angeles, California and I'm here today at ASCRS 2023. I'm excited to talk to you today about a new FDA clinical trial with a new device called StableVisc that we recently got FDA approved and will now be launched on the market by Bausch + Lomb.

In the FDA clinical trial, we looked at several different key factors or parameters. One of the primary endpoints was looking at endothelial cell density postoperatively compared to preop at 3 months. In addition, we also looked at IOP spikes postoperatively greater than 30 mm Hg to see whether or not patients actually had problems.

The study looked at StableVisc (which is the new viscoelastic from Bausch + Lomb), which is a hyaluronic acid combined with sorbitol which gives us several different properties. With the sorbitol, we have an improvement in reduced free radical formation in the anterior chamber commonly associated with phacoemulsification. In addition, the high molecular weight of the device really gives us stability as we do our capsulotomies and protection of the cornea in general.

When we looked at the data, what was interesting to find out...we compared this to the standard ProVisc and we looked at what the inferiority was of the devices. What we found was there was no inferiority. StableVisc performed extremely well compared to ProVisc. When we looked at endothelial cell density, we had about the equivocal portion of endothelial cell loss compared to ProVisc. It was about 17% in both groups comparing baseline to postoperative 3 months' time point.

When we looked at IOP data it was interesting. We actually had improved non-inferiority where StableVisc actually had less IOP spikes compared to ProVisc, about 5% in the StableVisc group and 8% in the ProVisc group.
I think what's really exciting is we now have this opportunity to join a great technology that we have with ClearVisc, and now StableVisc, as a product called TotalVisc which is going to give our surgeons more opportunities to protect their patients' corneas, offering better day 1 corneal clarity and improved outcomes with cataract surgery. It's really exciting and thank you very much for sharing.