FDA Approves Bausch + Lomb ClearVisc Dispersive Ophthalmic Viscosurgical Device (OVD)
April 14, 2021
Posted by Eyewire News
Bausch + Lomb, announced that the FDA has approved ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.
“OVDs play a critical role in ophthalmic surgery, and ClearVisc offers surgeons unique advantages that are designed to contribute to surgical safety and effectiveness and to enable excellent outcomes,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in a company news release. “We are excited to bring forward this latest advancement in OVDs to help address the unmet needs of our customers and their patients.”
ClearVisc contains Sorbitol, which is a unique chemical agent that has been shown in a laboratory 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 the 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 multicenter, randomized, clinical study of 372 subjects, ClearVisc met its primary safety and efficacy endpoints and was demonstrated to be noninferior to Viscoat. No serious adverse events were seen with ClearVisc eye surgeries. Clear corneas were seen in 91% of eyes for ClearVisc and 92% of eyes for Viscoat at 1-day post-operative and in 100% of eyes for ClearVisc and 98% of eyes for Viscoat at 1-week postoperative.1
“The dual protection provided by ClearVisc helps to ensure protection of the cornea as well as outstanding surgical outcomes,” John Berdahl, MD, clinician and researcher, Vance Thompson Vision, Sioux Falls, S.D. and ClearVisc clinical trial investigator, said in the news release. “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 excellent 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, which reduces the need to open a second pack mid-procedure.1
- Data on File. Bausch & Lomb Incorporated, 2021.
- 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.
- American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-are-cataracts. Accessed March 20, 2021.
- U.S. Centers for Disease Control and Prevention Web site, Vision Health Initiative (VHI). Retrieved from https://www.cdc.gov/visionhealth/basics/ced/index.html#:~:text=external%20icon-,Cataract,can%20be%20present%20at%20birth. Accessed April 2, 2021
- American Academy of Opthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-cataract-surgery. Accessed April 2, 2021
- National Eye Institute Website. Retrieved from https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/cataracts/cataract-surgery. Accessed April 2, 2021.