FOR MORE INFORMATION: Carrie Sessine, Golin/Harris International312-729-4152, [email protected]
Amanda Cancel, CIBA Vision 678-415-3646,[email protected]
FDA APPROVES FOCUS(r) NIGHT & DAY(tm) CONTACT LENSES FOR EXTENDED WEAR FOR UP TO 30 NIGHTS OF CONTINUOUS WEARFirst Contact Lens of Its Kind with this Wearing Indication in the U.S.Revolutionary Lens offers Comfortable Vision Correction Around the Clock
ATLANTA, October 12, 2001 -- Today, the U.S. Food and Drug Administration (FDA) approved CIBA Vision's Focus(r) NIGHT & DAY(tm) contact lenses for extended wear for up to 30 nights of continuous wear. NIGHT & DAY lenses are the first high-oxygen, extended wear, soft lens with this wearing indication in the United States.
"NIGHT & DAY is the most significant advance in contact lens materials since soft lenses were introduced more than 30 years ago," said Stuart Heap, president of CIBA Vision's global lens business. "CIBA Vision's commitment to innovation has produced a breakthrough product that delivers what lens wearers want -- convenient, continuous vision correction that easily fits with their busy and unpredictable lifestyles."
Because they can be worn continuously for up to 30 nights and days, NIGHT & DAY soft contact lenses can eliminate the tedious, daily hassles of inserting, removing and cleaning lenses. Lenses are simply discarded after a month of providing clear and comfortable vision around the clock.
"NIGHT & DAY lenses are also a good alternative to laser vision surgery for the millions of individuals who desire around-the-clock, clear vision but who are not good candidates for the procedure or who are averse to it because of its high costs, invasiveness, non-reversibility and potential complications," Heap said.
NIGHT & DAY lenses are made from a revolutionary, new, silicone hydrogel material that supplies six times more oxygen to the eye (an oxygen transmissibility of 175 Dk/t) than ordinary disposable lenses and 40 percent more oxygen than the minimum threshold (125 Dk/t) recognized by independent researchers for overnight wear of lenses. The unique, biocompatible properties of the lenses also help minimize deposit buildup over time.
Insufficient oxygen compromises normal eye function and may cause the cornea to swell. While minimal swelling is common during sleep, even in people who do not wear contact lenses, sleeping in ordinary contact lenses substantially reduces oxygen supply to the eyes which can cause the cornea to swell significantly and often results in very irritated eyes and uncomfortable lens wear. In research studies users wearing NIGHT & DAY lenses experienced minimal swelling similar to those wearing no lens at all and significantly less limbal redness than is typically seen with soft contact lens wear.
"NIGHT & DAY lenses are the first to meet patients' demands for the ultimate in vision correction convenience, and as an eye care practitioner, they meet my requirements for outstanding clinical performance," said Dr. N. Rex Ghormley, president of Vision Care Consultants in St. Louis, Mo. and participating optometrist in the FDA clinical trial for NIGHT & DAY.
Since 1999, more than 250,000 patients in more than 40 countries outside of the United States have worn NIGHT & DAY for up to 30 continuous nights and days. In addition, CIBA Vision has amassed more than 2,000 patient-years of clinical study with NIGHT & DAY, making it one of the most thoroughly researched contact lenses in history.
While virtually all people who need vision correction are candidates for NIGHT & DAY, not everyone can reach the maximum wear time of 30 continuous nights. People should consult with their eye care practitioner to determine if the lenses are suitable for them.
NIGHT & DAY lenses will be available through U.S. eye care practitioners later this fall. The lens will be offered in two base curve sizes of 8.6 mm and 8.4 mm and the power range will include +0.25D to +6.00D in 0.25D steps, -0.25D to -8.00D in 0.25D steps and -8.50D to -10.00D in 0.50D steps. Lenses will be priced competitively with reusable contact lenses currently on the market.
With worldwide headquarters in Atlanta, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products and ophthalmic surgical products. CIBA Vision products are available in more than 70 countries. For more information, visit the CIBA Vision website at www.cibavision.com.
CIBA Vision is the eye care unit of Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye care and animal health. In 2000, the Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Forward Looking StatementsThis release contains forward-looking statements, which can be identified by forward-looking terminology such as "expected", "will", "anticipates", or similar expressions, or by discussions of strategy, plans or intentions. Such statements involve known and unknown factors that may cause the actual results to be materially different from any results or achievements expressed or implied by such statements. In particular, management's expectations could be affected by unexpected regulatory delays and uncertainties relating to clinical trials and product development, the company's ability to obtain or maintain patent and other proprietary intellectual property protection, and competition, in general.
# # #
RSS