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Bausch Health : FDA Approves Bausch + Lomb ClearVisc™ Dispersive Ophthalmic Viscosurgical Device
|04/07/2021 | 07:31am|
New OVD Offers Exceptional Corneal Protection, Visibility During 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," said
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.
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 non-inferior 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 post-operative.1
"The dual protection provided by ClearVisc™ helps to ensure protection of the cornea as well as outstanding surgical outcomes," said
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
About Cataracts and Cataract Surgery
A clouding of the normally clear lens of the eye most commonly caused by aging,3 cataracts are a leading cause of vision loss in
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CLEARVISC™ OVD
INDICATIONS FOR USE
ClearVisc™ is indicated for use as a surgical aid in ophthalmic anterior segment procedures including: Extraction of a cataract; Implantation of an intraocular lens (IOL)
There are no contraindications to the use of ClearVisc™ when used as a surgical aid in ophthalmic anterior segment procedures.
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.
- Do not use if the sterile barrier has been breached. Sterility cannot be guaranteed, and the patient will be at increased risk for infection.
- An excess quantity of ClearVisc™ should not be used. Excess OVD can cause increased intraocular pressure.
- ClearVisc™ should be removed from the anterior chamber at the end of surgery to prevent or minimize postoperative intraocular pressure increases (spikes). OVD remaining in the eye can cause increased intraocular pressure.
- If the postoperative intraocular pressure increases above expected values, corrective therapy should be administered. Increased intraocular pressure may lead to inflammation or vision loss.
- Do not re-use the cannula. Even after cleaning and rinsing, resterilized cannula could release particulate matter as ClearVisc™ is injected. It is recommended that a single-use disposable cannula be used when administering ClearVisc™. Reuse may cause eye inflammation.
- If any particulate matter is observed, it should be removed by irrigation and/or aspiration. Particulate matter left in the eye may cause increased IOP or Light scattering /obstruction.
- Store at 2° to 8°C (36° to 46°F). Protect from freezing. The shelf life of ClearVisc™ is not guaranteed if it is not properly stored.
Sodium hyaluronate is a natural component of tissues within the body and is generally well tolerated in human eyes. Transient postoperative inflammatory reactions and increases in intraocular pressure have been reported. Inflammation may result from increased intraocular pressure caused by use of the OVD. Intraocular inflammation, i.e., toxic anterior segment syndrome (TASS), has been attributed to OVDs. Furthermore, vision loss may be possible as a result of increased intraocular pressure and inflammation.
Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc.
About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in
- 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 Website, 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.
ClearVisc is a trademark of
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