CHINO HILLS, CALIF. – Hoya Surgical Optics, Inc, (HSO) a subsidiary of Hoya Corporation (Tokyo, Japan) announced today it has received U.S. Food and Drug Administration (FDA) approval to begin marketing of the iSpheric™ Model YA- 60BB Intraocular Lens in the United States.
The iSpheric™ Model YA-60BB Intraocular Lens is a foldable hydrophobic acrylic intraocular lens with blue PMMA haptics and a blue-light absorbing yellow optic that absorbs almost all potentially harmful ultraviolet light. The lens can be implanted using an inserter through an un-enlarged phaco incision. In early 2009, HSO plans to introduce a new version of the lens packaged in a sterile, disposable, pre-loaded plastic injector. The iSert™ pre-loaded injector is designed to virtually reduce lens handling time in the operating room and eliminate loading errors that can lead to damaged lenses commonly associated with other foldable IOLs.
HSO expects to begin shipping the current iSpheric™ Intraocular Lenses to surgical facilities throughout the United States later this year.
The iSpheric™ Model YA-60BB Intraocular Lens was evaluated in over 600 clinical study subjects in the FDA clinical trial. Visual acuity results were excellent with over 98% of subjects reporting 20/40 or better Best Corrected Visual Acuity (BCVA) beginning at one month postoperative and maintaining that through the study’s main endpoint, 12 months postoperative. These rates for BCVA exceeded the FDA “Grid” with no lens-related adverse events or significant postoperative complications.
“The iSpheric™ lens has been widely available and well accepted for several years in Japan and Europe,” noted the Medical Monitor for the FDA study, Penny A. Asbell, MD, Professor of Ophthalmology, Director of Cornea and Refractive Services; Mount Sinai School of Medicine, New York, New York, USA, “so the U.S. results are not surprising. The lens is well tolerated and the data from the color-vision sub-study that was part of the FDA trials showed that patients reported no color vision disturbances due to the yellow optic. So, they get additional UV protection without any visual tradeoff.”
“We will begin selling the iSpheric lenses later this year,” reported Yasuro Mori, President of Hoya Surgical Optics, Inc. He added, “We are excited about the upcoming AAO meeting in Atlanta, GA where we can start to introduce ourselves to U.S. surgeons as well as industry professionals interested in working with us as we rapidly build our ophthalmic product portfolio.”
About Hoya Corporation Hoya Corporation is a global leader in information technology, eye care, medical devices and imaging systems. With over 35,000 employees and operations across the globe, Hoya recorded total sales of over JPY 481.6 billion (US$ 4.37 billion) in fiscal year 2007. Hoya was founded in 1941 and trades on the First Section of the Tokyo Stock Exchange. Hoya Surgical Optics is a subsidiary of Hoya Corporation and has been a worldwide manufacturer and distributor of intraocular lenses for over 20 years.