CooperVision Receives FDA Approval for Biofinity® Silicone Hydrogel Contact Lenses as an Extended-Wear Lens

Mon, Dec 1, 2008

CooperVision announced today that its Biofinity® silicone hydrogel contact lenses have been approved by the FDA for extended wear in the United States, providing indication for overnight wear for up to six nights and seven days. The extended-wear approval is effective immediately, and applies to all Biofinity monthly replacement lenses currently available.

Designed with Aquaform™ technology, Biofinity monthly replacement lenses are made with a unique, naturally wettable lens material that offers high water content, a low modulus, and high oxygen transmissibility. Now, with the recent FDA approval, patients can enjoy the exceptional comfort, optimal health, and excellent performance associated with Biofinity monthly replacement lenses for extended periods. In addition, practitioners can now fit their patients with Biofinity, used on an extended wear basis, using lenses from their existing Biofinity fitting sets, without the need for new trial lenses.

“Aquaform technology creates a naturally wettable lens material without the need for wetting agents or surface treatments,” said James Gardner, director of marketing, CooperVision. “With a high Dk/t of 160 and the FDA approval for extended wear, practitioners can now offer a very high oxygen silicone hydrogel lens which is almost 50 percent softer than the highest Dk silicone hydrogel lens currently available.”

Additionally, Aquaform technology incorporates longer-chain siloxane molecules, thus requiring less siloxane to be incorporated into the lens material and aiding in oxygen transmissibility. This optimizes the relationship between oxygen and water, creating a more flexible lens material that stays moist and comfortable throughout the day.

The aspheric front surface lens design improves visual performance, and the single base curve and back surface design enable fast, easy alignment and a quicker fitting process. Advanced aspheric optics minimize spherical aberrations, enhancing visual clarity. In addition, a patented molded round edge reduces conjunctival interaction—resulting in continuous wearing comfort for the patient.

Wearers also preferred the end-of-day comfort of Biofinity versus their previous lenses, Night & Day and PureVision. Research showed that 66 percent of those who switched from their previous contacts after six months of wearing Biofinity preferred the comfort of CooperVision’s premium silicone hydrogel lens1.

“Since its availability last summer, Biofinity has become a first choice lens to many eye care practitioners looking to fit their patients with the latest silicone hydrogel lens technology.” added Gardner.

Biofinity lenses are manufactured with a third-generation silicone hydrogel material, comfilcon A. The water content of Biofinity is 48 percent, Dk is 128, and Dk/t is 160. The lens also features a base curve of 8.6mm, a diameter of 14.0mm, and is available in a sphere power range of +8.00D to -12.00D.

About CooperVision
CooperVision, a unit of The Cooper Companies, Inc. [NYSE: COO], is one of the world’s leading manufacturers of soft contact lenses. Dedicated to enhancing the contact lens experience for practitioners and patients, CooperVision specializes in lenses for astigmatism, presbyopia, and ocular dryness. CooperVision manufactures a full array of monthly, two-week, and daily disposable contact lenses featuring advanced materials and optics. For more information, visit www.coopervision.com.

1 Loftstrom. “Poster Presentation.” American Academy of Optometry. 2005. (Habitual SiH lenses tested are lotrafilcon A and balafilcon A lenses.)

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