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NEWS OF 1999

NEWS OF 1998

(Dec. 22, 1998)
Nidek excimer laser receives FDA approval

(Oct. 23, 1998)
Nidek wins U.K. excimer laser patents battles with VISX


(Aug. 26, 1998)
Fremont Mayor Visits Nidek, Inc.


(Jul. 27, 1998)
Court Rejects Essilor's Suit Against Nidek And Santinelli


(Feb. 1998)
Nidek Acquires LaserSight-IBM Patents for $7.5 Million


NEWS OF 1997

 
 

NIDEK EXCIMER LASER RECEIVES FDA APPROVAL


- GAMAGORI, JAPAN, December 22, 1998 -

NIDEK, CO., Ltd., manufacturer of the EC-5000 excimer laser system announced today the successful completion of its PRK clinical study and receipt of U.S. Food an Drug Administration (FDA) approval to commence marketing and sales in the United States. The instrument has been found to be safe and effective for photorefractive keratectomy (PRK) correction of myopia (nearsightedness) ranging from -0.75 to -13.0 diopters. Supplemental applications will be submitted in the near future, for correction of astigmatism up to 4.0 diopters. A clinical study for correction of hyperopia (farsightedness) is also underway.

The approval marks the culmination of a four year process to obtain regulatory approval and the right to sell in the United States. NIDEK is the first non-U.S. based company to successfully navigate the demanding FDA regulatory process, and the first to bring rapid, linear beam scanning technology to market. The company's patented beam delivery system - well known and highly respected by international excimer surgeons - uses a rotating, rectangular beam of ultraviolet light to quickly modify the optical power of the cornea. For patients choosing this surgery option, this technology enables the reduction or elimination of the need to wear contact or spectacle lenses for many activities. The laser automatically imparts a transition zone between the ablated and unablated areas of the cornea to facilitate healing.

NIDEK Co., Ltd. is a 27 year-old, privately held company located in Japan, with subsidiary offices in the United States and France. NIDEK manufactures intraocular lenses and surgical & diagnostic instrumentation for eye care specialists in over 90 countries. The company's EC-5000 excimer laser system has been in development since 1985. Excimer lasers are used to correct refractive errors by altering the shape and optical power of the cornea, in a procedure performed on an out-patient basis. Approximately 400 EC-5000 instruments are currently in use throughout the world.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, and the accuracy of which is necessarily subject to the uncertainties of future market and product development, and the demand for the company's products, among other matters discussed in this release, may differ significantly from the discussion of such matters in these forward-looking statements.

For information on clinical studies, please contact Dr. Ray Sayano of NIDEK TECHNOLOGIES, INC. at (626) 578-1351. For sales and marketing information, please contact Mr. David Yeh of NIDEK, Inc. at (800) 223-9044, extension 724.


Risks and Benefits:

The United States Food and Drug Administration (FDA) has approved the Nidek EC-5000 Excimer Laser System for use in the United States to perform photorefractive keratectomy (PRK) for the reduction or elimination of myopia in the low, moderate, or high ranges (-0.75 to -13.00 D), spherical equivalent at the spectacle plane, uncomplicated by refractive astigmatism (i.e. 0.75 D or less in any meridian).

Alternatives to PRK: Eyeglasses, contact lenses, LASIK, radial keratotomy or automated lamellare keratoplasty. In studies of 587 eyes (consistent cohort) after final treatment with refractive data at 6 months, 91.3% were corrected to 20/40 or better and 60.6% were corrected at 20/20 or better without spectacles or contact lenses.

U.S. Clinical Trial Adverse Events: The percentage of individuals with 20/20 or better per-op had best corrected spectacle visual acuity worse than 20/25 in the following proportions: 4.0% (-6.00 to -9.00 D) and 4.8% (> -10.00 D).

U.S. Clinical Trial Complications: An increase in fluctuation of vision (34.1% pre-op vs. 48.1% post-op); glare (26.9% pre-op vs. 34.4% post-op); and difficulty in night driving (23.5% pre-op vs. 48% post-op).




 

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