The FDA has granted Bausch + Lomb Corporation premarket approval (PMA) for its StableVisc Ophthalmic Viscosurgical Device (OVD) used during cataract surgery.
Tell me more about this device.
The StableVisc OVD is designed as a thick, transparent fluid (1.0% sodium hyaluronate) injected via a syringe during cataract surgery.
The device is best optimized when injected prior to cataract extraction and the insertion of the IOL, and is also effective for phacoemulsification cataract procedures.
What does it do?
The OVD maintains the anterior chamber space, re-inflates the capsular bag for intraocular lens (IOL) insertion, and can protect against corneal endothelial cell loss.
Any clinical trials on this?
A prospective, multi-center, two-armed, randomized, partially-masked, comparative clinical trial enrolled 390 patients with age-related, non-complicated cataract across 22 sites. Participants were randomized—by site, age group, and severity of cataract—1:1 ahead of their planned cataract surgery with a posterior chamber IOL implantation to receive either the StableVisc OVD or a control OVD (ProVisc OVD, an FDA-approved alternative).
Investigators included only one eye of each patient to study, and followed participants for 90 days post-op.
How did it perform?
Three months following cataract surgery, patients’ average loss of endothelial cells was found to not be significantly different between the StableVisc OVD-treated eyes (17.6 cells for every 100) and eyes that received the alternative (16.9 cells for every 100).
With the FDA’s approval, Bausch + Lomb can begin commercial distribution, providing it adheres to specific conditions, as outlined in its official premarket approval letter, as a class III device.
The StableVisc OVD’s approval will expire after two years, in which the company must provide proper documentation and reporting verifying its continued safety and efficacy as a PMA device.