BRIDGEWATER, N.J., May 9, 2018 – Bausch + Lomb, a leading global eye health company, announced today that it has initiated a clinical trial evaluating the safety and efficacy of a new ophthalmic viscosurgical device (OVD) intended to provide a novel formulation to meet the needs of today’s cataract surgeons.
“OVDs play a critical role in ophthalmic surgery, and selection is highly individualized based on clinical surgical requirements and the surgeon’s preferences,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb. “Our goal is to provide surgeons with a new option as part of our commitment to delivering innovations that expand their cataract surgery armamentarium.”
Bausch + Lomb aims to file for pre-market approval (PMA) with the FDA at the conclusion of the clinical trial, with plans to bring this next-generation OVD to the U.S. market in 2019.
OVDs aid in ophthalmic anterior segment procedures, including cataract extraction and intraocular lens (IOL) implantation, by creating and maintaining space during lens extraction and IOL implantation, aiding in tissue manipulation during surgery, enhancing visualization during the surgical procedure, and protecting the corneal endothelium and other intraocular tissues. OVDs may also be used to coat IOLs and instruments during ophthalmic anterior segment surgical procedures.
About Cataracts and Cataract Surgery
A clouding of the normally clear lens of the eye, cataracts are a leading cause of blindness in the U.S. and worldwide. The most common cause of cataracts is aging. An estimated 50 percent of Americans will be affected by the time they reach age 75.
Cataract surgery is when a cloudy lens is removed and replaced with a clear, artificial lens called an IOL. According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures. In the U.S. alone, 2 million cataract surgeries are performed annually. In most cases, people experience improved vision after the procedure.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries.
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