{"id":472550,"date":"2021-04-07T07:33:24","date_gmt":"2021-04-07T11:33:24","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=472550"},"modified":"2021-04-07T07:33:24","modified_gmt":"2021-04-07T11:33:24","slug":"fda-approves-bausch-lomb-clearvisc-dispersive-ophthalmic-viscosurgical-device","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-bausch-lomb-clearvisc-dispersive-ophthalmic-viscosurgical-device\/","title":{"rendered":"FDA Approves Bausch + Lomb ClearVisc\u2122 Dispersive Ophthalmic Viscosurgical Device"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n New OVD Offers Exceptional Corneal Protection, Visibility During Ophthalmic Surgery<\/b>\n <\/p>\n

LAVAL,\u00a0QC, April 7, 2021<\/span> \/PRNewswire\/ —\u00a0Bausch + Lomb,\u00a0a leading global eye health business\u00a0of Bausch Health Companies Inc. (NYSE\/TSX: BHC) (“Bausch Health”), today announced that the U.S. Food and Drug Administration (FDA) has approved ClearVisc\u2122 dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery.<\/p>\n

“The ClearVisc\u2122 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,” said Joe Gordon<\/span>, U.S. president, Bausch + Lomb. “OVDs play a critical role in cataract surgery as well as many other ophthalmic surgeries. ClearVisc\u2122 offers significant advantages that can help surgeons deliver the best possible outcomes for their patients.”\u00a0 <\/p>\n

OVDs aid 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.<\/p>\n

ClearVisc\u2122 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<\/sup> 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\u2122 helps provide physical protection of the cornea from thermal and mechanical damage as well as chemical protection from damaging free radicals. <\/p>\n

In a multicenter, randomized, clinical study of 372 subjects, ClearVisc\u2122 met its primary safety and efficacy endpoints and was demonstrated to be non-inferior to VISCOAT\u00ae.\u00a0No serious adverse events were seen with ClearVisc\u2122 eye surgeries. Clear corneas were seen in 91% of eyes for ClearVisc\u2122 and 92% of eyes for VISCOAT\u00ae at 1-day post-operative and in 100% of eyes for ClearVisc\u2122 and 98% of eyes for VISCOAT\u00ae at 1-week post-operative.1<\/sup>\u00a0<\/p>\n

“The dual protection provided by ClearVisc\u2122 helps to ensure protection of the cornea as well as outstanding surgical outcomes,” said John Berdahl<\/span>, M.D., clinician and researcher, Vance Thompson Vision, Sioux Falls, S.D.<\/span> and ClearVisc\u2122 clinical trial investigator. “In my experience as an investigator, I was pleased with the level of control and safety that ClearVisc\u2122 delivered throughout the procedure.”<\/p>\n

ClearVisc\u2122 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<\/sup> ClearVisc\u2122 is also supplied in a 1.0 ml syringe, which reduces the need to open a second pack mid-procedure.1<\/sup><\/p>\n

\n About Cataracts and Cataract Surgery <\/b>
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A clouding of the normally clear lens of the eye most commonly caused by aging,3<\/sup> cataracts are a leading cause of vision loss in the United States<\/span> and the leading cause of blindness worldwide.4<\/sup> In the U.S., more than 20 million people aged 40 years and older have a cataract, and more than 6 million of these Americans undergo surgery to have the lens removed.4 <\/sup>An ophthalmic surgeon removes the cloudy lens and replaces it with a clear, artificial implant called an intraocular lens (IOL).5<\/sup>\u00a0According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures performed in the United States<\/span>.6<\/sup> In most cases, people experience improved vision after the procedure.6<\/sup><\/p>\n

\n INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CLEARVISC\u2122 OVD<\/b>\n <\/p>\n

\n INDICATIONS FOR USE
<\/b>ClearVisc\u2122 is indicated for use as a surgical aid in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL)<\/p>\n

\n CONTRAINDICATIONS
<\/b>There are no contraindications to the use of ClearVisc\u2122 when used as a surgical aid in ophthalmic anterior segment procedures. <\/p>\n

\n PRECAUTIONS
<\/b>Precautions normally considered during anterior segment procedures are recommended. Pre-existing glaucoma may place patients at risk for increases in intraocular pressure from the OVD during the early postoperative period.\u00a0 <\/p>\n

\n WARNINGS<\/b>\n <\/p>\n