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FDA Approval For ACUVUE(R) OASYS(TM) With HYDRACLEAR(TM) PLUS

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JACKSONVILLE, Fla. PRNewswire/ -- VISTAKON®, a division of

Johnson & Johnson Vision Care, Inc., today announced that the U.S. Food & Drug

Administration has granted an additional indication for ACUVUE® OASYS™

Brand Contact Lenses with HYDRACLEAR™ PLUS, approving the daily-wear

contact lens for up to 6 consecutive nights/7 days of extended wear.

 

ACUVUE OASYS is a breakthrough for contact lens wearers when their eyes

feel tired and dry in challenging environments, such as long hours of computer

use, frequent ground or air travel, or everyday exposure to heated or air

conditioned surroundings. It is the first daily-wear contact lens made from

senofilcon A, a new silicone hydrogel material that is 50 percent smoother

than currently available silicone hydrogel lenses. In addition to its smooth

feel, the new lens also features an improved formulation of the unique

HYDRACLEAR™ technology that combines high performance base materials with a

moisture-rich wetting agent. ACUVUE OASYS block greater than 96 percent of UVA

rays and 99 percent of UVB rays, meeting the highest UV-blocking standards for

contact lenses. # *

"Contact lens wearers can now occasionally nap or sleep in ACUVUE OASYS

and still get the same excellent health and comfort benefits they receive when

it's worn as a daily lens," said Pat Cummings, OD, vice president of

Professional Affairs, VISTAKON. "We strongly advise all contact lens wearers

to follow their doctor's instructions for lens wearing schedule, replacement

frequency, and care regimen, and to discuss the benefits and risks of extended

wear lenses with their eye care professional before changing their wearing

schedule."

Problems with discomfort due to dryness affect approximately 67 percent of

the more than 36 million contact lens wearers in the United States, with about

four in ten (42 percent) wearers reporting that they use rewetting drops at

least once a day to keep their eyes from feeling dry. And, while 3 million

people a year become new contact lens wearers, studies suggest that during the

same period approximately 2.7 million people stop wearing contact lenses, with

one in four (24 percent) citing dry, challenging environments or wearing

conditions as reasons for discontinuing contact lens wear.

In a clinical study with more than 190 contact lens wearers, patients

wearing ACUVUE OASYS reported consistently clear, crisp vision and noted that

their eyes remained fresh and moist, even in challenging environments. Three

in four (75 percent) study participants also noted that they did not need

rewetting drops while wearing ACUVUE OASYS.

 

ACUVUE OASYS with HYDRACLEAR PLUS is the third entry in the ULTRA COMFORT

SERIES™ family of products, following the introduction of ACUVUE®

ADVANCE™ Brand Contact Lenses with HYDRACLEAR™ and ACUVUE® ADVANCE™

Brand Contact Lenses for ASTIGMATISM. The ULTRA COMFORT SERIES offers

 

exceptional comfort to wearers of all ages by providing all-day moisture,

smooth fit, a soft and flexible feel, and maximum ultraviolet protection.

ACUVUE OASYS with HYDRACLEAR PLUS is available in the offices of eye care

professionals throughout the United States.

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS are indicated for

daily-wear vision correction and may also be worn for up to 6 consecutive

nights/7 days of extended wear as recommended by their eye care professional.

Contact lenses should not be worn for longer periods than recommended by an

eye care professional. As with all contact lenses, eye problems, including

corneal ulcers, can develop. Some wearers may also experience mild irritation,

itching or discomfort. Lenses should not be worn if the wearer has an eye

infection or experiences eye discomfort, excessive tearing, vision changes,

redness or other eye problems. For more complete information patients should

talk to their eye care professional, or call 1-800-843-2020 or visit

http://www.acuvue.com .

 

Johnson & Johnson Vision Care Inc.

The VISTAKON division of Johnson & Johnson Vision Care, Inc. specializes

in disposable contact lenses which it markets under such brand names as

ACUVUE®, ACUVUE® ADVANCE™ with HYDRACLEAR™, ACUVUE® ADVANCE™

for ASTIGMATISM, ACUVUE® OASYS™ with HYDRACLEAR™ PLUS, ACUVUE® and

ACUVUE® 2; 1-DAY ACUVUE®; ACUVUE® BIFOCAL; ACUVUE® TORIC, and

ACUVUE® 2 COLOURS™.

ACUVUE®, ACUVUE® ADVANCE™, HYDRACLEAR™, ACUVUE® OASYS™,

ACUVUE® 2 COLOURS™, ULTRA COMFORT SERIES™ and VISTAKON® are

trademarks of Johnson & Johnson Vision Care, Inc.

 

# Helps protect against transmission of harmful UV radiation to the cornea

and into the eye.

* WARNING: UV-absorbing contact lenses are NOT substitutes for protective

UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they

do not completely cover the eye and surrounding area. You should continue to

use UV-absorbing eyewear as directed. NOTE: Long term exposure to UV radiation

is one of the risk factors associated with cataracts. Exposure is based on a

number of factors such as environmental conditions (altitude, geography, cloud

cover) and personal factors (extent and nature of outdoor activities). UV-

Blocking contact lenses help provide protection against harmful UV radiation.

However, clinical studies have not been done to demonstrate that wearing UV-

Blocking contact lenses reduces the risk of developing cataracts or other eye

disorders. Consult your eye care practitioner for more information.

 

Publish Date: 12/23/2005

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