FDA approves Bausch + Lomb's ClearVisc OVD
Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device has received FDA approval for use in ophthalmic surgery, according to a press release.
ClearVisc protects the cornea from thermal and mechanical damage, and contains sorbitol, which delivers free radical protection, decreasing risk of corneal damage and decompensation during cataract extraction and implantation of IOLs, according to the release.
The product was tested in a multicenter randomized clinical study of 372 subjects. ClearVisc produced no serious adverse events and met its primary safety and efficacy endpoints.
"OVDs play a critical role in cataract surgery as well as many other ophthalmic surgeries,” Joe Gordon, U.S. president of Bausch + Lomb, said in the release. “ClearVisc offers significant advantages that can help surgeons deliver the best possible outcomes for their patients."