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Bausch + Lomb Receives FDA Approval for the TRULIGN™ Toric Posterior Chamber Intraocular Lens
ALISO VIEJO, Calif.
, May 21, 2013
/PRNewswire/ -- Bausch + Lomb, the global eye health company, today announced that it is has received approval from the U.S. Food and Drug Administration (FDA) for the TRULIGN
Toric posterior chamber intraocular lens
(IOL). The TRULIGN
Toric intraocular lens is the first toric IOL that corrects for astigmatism and, unlike other standard toric lenses, has the additional capacity to deliver improved vision across a natural range of focus. The lens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.
Jay Pepose, M.D., Ph.D, of the Pepose Vision Institute in St. Louis, MO, and medical monitor of the FDA clinical trial, had this to say about the performance of the TRULIGN Toric IOL:
"I'm very excited about the TRULIGN Toric intraocular lens because it is the first product that addresses two important unmet clinical needs of cataract patients in a single procedure: One of which is offsetting substantial preexisting corneal astigmatism, which impacts over one in three patients. The other is the desire that patients express to have excellent uncorrected distance and intermediate vision with improved near vision," said Dr. Pepose. "Due to advancements in the TRULIGN Toric, there are the real-world benefits that patients will enjoy with this lens. We can offer patients a premium intraocular lens that enhances their visual acuity and can reduce the need to wear glasses for their day-to-day activities. I look forward to introducing the TRULIGN Toric lens into my own practice."
"Bausch + Lomb's TRULIGN Toric intraocular lens represents a significant step forward in intraocular lens technology, providing predictable astigmatism correction combined with improved visual acuity for an active lifestyle,1" said Calvin Roberts, M.D., executive vice president and chief medical officer, Bausch + Lomb. "The new TRULIGN Toric lens is the latest in a long line of innovations from Bausch + Lomb for cataract patients. Through its unique haptic design, this premium lens offers superior rotational stability1 which is critical for astigmatism correction. In addition, the TRULIGN Toric IOL optic is designed to minimize dysphotopsia and potential impact from low contrast conditions."
In the FDA clinical trial, the TRULIGN Toric intraocular lens demonstrated improved uncorrected near, intermediate and distance vision. The unique haptic design provided superior rotational stability, with 96.1 percent of the lenses rotating less than five degrees from the day of surgery to four-to-six months post-op.1
About Cataract Surgery and Intraocular Lenses
According to the World Health Organization, there are about 100 million people in the world today who are 80 years old or older. That number is expected to almost quadruple by 2050. Aging is the leading cause of eye diseases, such as cataracts. A cataract is a clouding of the normally clear lens in the eye. It also happens to be the leading cause of blindness in the world. According to the National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures. Worldwide, over 20 million cataract surgeries are performed annually. Cataract surgery is a simple procedure during which the natural lens in the patient's eye is surgically replaced with an IOL.
About TRULIGN Toric
The TRULIGN Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.
About Bausch + Lomb
Bausch + Lomb is a leading global eye health company that is solely focused on protecting, enhancing, and restoring people's eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries. Founded in 1853, our company is headquartered in Rochester, NY, and employs more than 11,000 people worldwide.
® / are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2013 Bausch & Lomb Incorporated.
1. Data on File. Bausch & Lomb Incorporated. Study 650.
SOURCE Bausch + Lomb