ClearVisc helps in providing physical protection for the cornea from thermal and mechanical damage
Bausch + Lomb has secured approval from the US Food and Drug Administration (FDA) for its ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.
ClearVisc consists of Sorbitol chemical agent, which was demonstrated to deliver better free radical protection compared to other dispersive OVDs in a laboratory study.
OVDs help in cataract extraction and intraocular lens (IOL) implantation by creating and maintaining space, thereby facilitating tissue manipulation and improving visualisation.
An OVD, which will also protect the corneal endothelium and other intraocular tissues, is also used to coat IOLs and instruments during cataract surgery.
ClearVisc offers physical protection for the cornea from thermal and mechanical damage, in addition to chemical protection from damaging free radicals.
Free radicals are formed due to chemical reactions caused during phacoemulsification, irrigation/aspiration and as part of the insertion and removal of instruments and implants.
They may result in corneal damage and decompensation that could lead to post-surgical complications such as a cloudy cornea.
ClearVisc achieved its primary safety and efficacy endpoints in a multicenter, randomised clinical study of 372 subjects. It was also shown to be non-inferior to VISCOAT.
According to the company, ClearVisc enables to provide better tissue visualisation and maintain anterior chamber space across all phases of lens removal and IOL insertion. It also enables easy removal during irrigation/aspiration.
ClearVisc is also provided in a 1.0ml syringe, which minimises the requirement to open a second pack mid-procedure.
Bausch + Lomb US president Joe Gordon said: “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.
“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.”
In October last year, Bausch + Lomb launched its SimplifEYE IOL delivery system in the US.
The company is offering SimplifEYE IOL delivery system exclusively for the enVista MX60PL and the enVista toric MX60PT monofocal preloaded intraocular lenses (IOLs).