FDAnews Device Daily Bulletin

J&J RECEIVES EXTENDED WEAR INDICATION FOR ACUVUE OASYS CONTACT LENSES

Dec. 27, 2005
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Johnson & Johnson (J&J) unit Vistakon has received FDA approval for an additional indication on its Acuvue Oasys brand contact lenses to include up to seven days of extended wear.

The Acuvue Oasys lenses already are approved for daily wear. The product is made from senofilcon A, a new silicone hydrogel material that is 50 percent smoother than currently available silicone hydrogel lenses, Vistakon said. The new lens also features an improved formulation of Vistakon's Hydraclear technology, which includes a moisture-rich wetting agent, the company said.

Problems with discomfort due to dryness affect roughly 67 percent of the more than 36 million contact lens wearers in the U.S., with roughly 42 percent reporting they use rewetting drops at least once a day to keep their eyes from feeling dry, said J&J. Studies suggest that each year approximately 2.7 million people stop wearing contact lenses, with 24 percent citing dry, challenging environments or wearing conditions as reasons for discontinuing contact lens wear, the company added.

In a clinical study with more than 190 contact lens wearers, patients wearing Acuvue Oasys reported their eyes remained fresh and moist, even in challenging environments, J&J said. Seventy-five percent of study participants also noted they did not need rewetting drops while wearing Acuvue Oasys lenses.