Bausch + Lomb announced today that it received FDA approval for its ClearVisc dispersive ophthalmic viscosurgical device (OVD).
Laval, Quebec-based Bausch + Lomb, the eye health business unit of Bausch Health, developed the ClearVisc OVD for use in ophthalmic surgery to aid in cataract extraction and intraocular lens (IOL) implantation through the creation and maintenance of space, tissue manipulation, visualization enhancement and corneal endothelium protection, according to a news release.
ClearVisc contains the chemical agent Sorbitol, which is designed to deliver superior free radical protection when compared to other dispersive OVDs. The device helps to provide physical protection of the cornea from thermal and mechanical damage, as well as the chemical protection from damaging free radicals.
A multicenter, randomized clinical study of 372 subjects saw ClearVisc meet its primary safety and efficacy endpoints, while the device proved non-inferior to Viscoat. No serious adverse events were seen in ClearVisc eye surgeries, with clear corneas seen in 91% of eyes treated with ClearVisc, compared to 92% of those treated with Viscoat at one-day post-operation.
However, 100% of those treated with ClearVisc has clear corneas at one week post-operation, while 98% of eyes treated with Viscoat had the same result.
“The ClearVisc dispersive OVD is the latest advancement in Bausch + Lomb’s rich pipeline of ophthalmic surgical devices and is representative of our company’s ongoing commitment to delivering innovations that fulfill the unmet needs of our customers,” Bausch + Lomb U.S. president Joe Gordon said in the release. “OVDs play a critical role in cataract surgery as well as many other ophthalmic surgeries. ClearVisc™ offers significant advantages that can help surgeons deliver the best possible outcomes for their patients.”