Bausch + Lomb’s ClearVisc Dispersive Ophthalmic Viscosurgical Device Approved

The U.S. Food and Drug Administration (FDA) has approved Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device (OVD) for ophthalmic surgery.
 
“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,” Joe Gordon, U.S. president, Bausch + Lomb told the press. “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.” 
 
OVDs assist in cataract extraction and intraocular lens (IOL) implantation by creating and maintaining space, aiding in tissue manipulation, enhancing visualization, and protecting the corneal endothelium and other intraocular tissues. OVDs may also be used to coat IOLs and instruments during cataract surgery.
 
ClearVisc contains Sorbitol, a unique chemical agent shown in a lab study to deliver superior free radical protection compared to other dispersive OVDs.^1,2 Free radicals form as a result of chemical reactions caused during phacoemulsification, irrigation/aspiration, and as part of insertion and removal of instruments and implants. Free radicals can contribute to corneal damage and possible decompensation, which can lead to post-surgical complications such as a cloudy cornea. ClearVisc helps provide physical protection of the cornea from thermal and mechanical damage as well as chemical protection from damaging free radicals.
 
In a clinical study of 372 subjects, ClearVisc met primary safety and efficacy endpoints and was demonstrated to be non-inferior to VISCOAT. No serious adverse events were seen with ClearVisc eye surgeries. Clear corneas were seen in 91 percent of eyes for ClearVisc and 92 percent of eyes for VISCOAT at 1-day post-operative and in 100 percent of eyes for ClearVisc and 98 percent of eyes for VISCOAT at 1-week post-operative.¹ 
 
“The dual protection provided by ClearVisc helps to ensure protection of the cornea as well as outstanding surgical outcomes,” said John Berdahl, M.D., clinician and researcher, Vance Thompson Vision, Sioux Falls, S.D. and ClearVisc clinical trial investigator. “In my experience as an investigator, I was pleased with the level of control and safety that ClearVisc delivered throughout the procedure.”
 
ClearVisc helps to ensure tissue visualization, maintains anterior chamber space throughout all phases of lens removal and IOL insertion, and is easily removed during irrigation/aspiration.¹ ClearVisc is also supplied in a 1.0 ml syringe, reducing the need to open a second pack mid-procedure.¹
 
References
¹ Data on File. Bausch & Lomb Incorporated, 2021.
² Francesco Maugeri, Adriana Maltese, Keith W. Ward & Claudio Bucolo (2007). Hydroxyl Radical Scavenging Activity of a New Ophthalmic Viscosurgical Device, Current Eye Research, 32:2, 105-111, DOI:10.1080/02713680601147716.