J & J Says New Daily Acuvue Contact Lens Gets FDA Approval

First and Only Silicone Hydrogel One-Day Contact Lens In The U.S.

Orlando, FL  (June 17, 2010) – VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., today announced that it has received clearance from the United States Food and Drug Administration (FDA) to market narafilcon B, the first and only silicone hydrogel daily disposable lens in the United States.  The company will market it under the name 1-DAY ACUVUE® TruEye™ Brand Contact Lenses, and here at the annual meeting of the American Optometric Association, revealed  that the product will be available in the offices of eye care professionals throughout the United States beginning this month.

“1-DAY ACUVUE® TruEye™ is a breakthrough in contact lens technology with a distinctive balance of properties that enables it to offer exceptional comfort, comparable to a contact lens-free eye,” says Dave Brown, President, VISTAKON®. “Fifteen years after VISTAKON® introduced the world’s first one-day disposable soft contact lens, we continue our heritage of and commitment to bringing healthy vision to everyone, everyday through innovative new products.”

Designed to keep eyes looking white and healthy, 1•DAY ACUVUE® TruEye™ combines narafilcon B, a next generation, high-performance silicone hydrogel material and HYDRACLEAR® 1, a proprietary formulation of the patented HYDRACLEAR® technology with the hygiene, flexibility and convenience of a one-day replacement lens. It also offers the highest level of UV protection in a contact lens.† **

1•DAY ACUVUE® TruEye™ was designed, developed, and clinically researched versus the ultimate benchmark: the natural eye,” explains Colleen Riley, OD, MS, FAAO, VP, Professional Development, VISTAKON®.

An ongoing one-year, 94-subject, randomized, investigator-masked, parallel group study, compares patients wearing 1•DAY ACUVUE® TruEye™ with patients who have never worn contact lenses.  After one month of wear, 1•DAY ACUVUE® TruEye™ was shown to have no significant effect on the ocular surface of the eye as compared to non-contact lens wearers across five of six contact lens related measures associated with eye health.  In addition, 1-DAY ACUVUE® TruEye™ was also shown to provide high levels of comfort from morning to night, comparable to wearing no lens at all.

“The data suggests that 1-DAY ACUVUE® TruEye™ can help maintain ocular health with the near ‘no-lens’ experience, and keep the lens wearing eye looking white and healthy, while also providing consistent comfort throughout the day,” says Dr. Riley.

1•DAY ACUVUE® TruEye™ provides wearers with the unique balance of all these 4 DIMENSIONS OF EYE HEALTH™: Comfortable Health, Visible Health, Everyday Health and Proactive Health.

Comfortable Health
The new lens features HYDRACLEAR® 1, an improved formulation of the unique HYDRACLEAR® technology that combines high performance base materials with a moisture-rich wetting agent. HYDRACLEAR®1 provides lasting comfort that wearers can feel consistently on an hourly and daily basis.

Visible Health
1•DAY ACUVUE® TruEye™ helps keep eyes looking naturally white and healthy, because its unique material allows eyes to breath freely throughout the day.  “It allows your eyes to breathe almost as if you were not wearing contact lenses at all,” explains Dr. Riley.

Everyday Health
A number of studies have shown that daily replacement is the healthiest way to wear contact lenses. By putting in a clean, fresh lens every day, one-day contacts help minimize the potential for buildup of allergens and irritants. Additionally, one-day contact lenses are a more convenient option for wearers because there is no need to clean or store the lenses.

Proactive Health
1•DAY ACUVUE® TruEye™ offers patients the highest level of UV protection in a contact lens, blocking more than 96 percent of UV-A rays and 99 percent of UV-B rays that reach the lens.† **

Although UV-blocking contact lenses provide important added protection for patients, they should not be viewed as a stand-alone solution. Contact lenses should always be worn in conjunction with high-quality UV-blocking sunglasses and a wide-brimmed hat for maximum UV protection for the eyes.

A free trial-pair certificate* for 1•DAY ACUVUE® TruEye™, is available at www.acuvue.com/trueye.

*Professional exam and fitting fees not included. Valid only while supplies last.

ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting www.acuvue.com.

† 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.

1•DAY ACUVUE® TruEye™, HYDRACLEAR®, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.



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