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Miles
Km80.5

   

FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec Inc.


3/29/2011 7:03:22 AM

DUBLIN, Calif., March 28, 2011 /PRNewswire/ -- Carl Zeiss Meditec, Inc. announced today that the MEL 80™ Excimer Laser has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the treatment of hyperopia. This new indication complements the existing FDA approved applications of the surgical laser for myopia and astigmatism.

"The MEL 80 combines premium optics with advanced excimer laser technology," said Ludwin Monz, president and chief executive officer of Carl Zeiss Meditec AG. "Adding the hyperopia indication enables us to offer a complete range of treatment options to meet the demands of refractive surgeons and their patients."

More commonly known as farsightedness, hyperopia makes it difficult for a patient to focus on near objects. "Hyperopia has always been a more difficult problem to treat with laser surgery," said Dr. Jon Dishler of Greenwood Village, CO. "Now with the MEL 80, the task is easier and more precise. Going forward, I would not attempt LASIK on my hyperopic patients without the MEL 80."

Clinical Results

The MEL 80 study for hyperopia included 189 patients age 22 to 69 years old, with a mean age of 47 years. A total of 369 eyes were treated. After 12 months, 148 patients, or 96.7 percent, showed uncorrected visual acuity of 20/40 or better. The results of the study were presented at the annual meeting of the American Society of Cataract and Refractive Surgery in San Diego on March 27.

FDA Indication

The MEL 80 Excimer Laser is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of > +0.5 D and < +3.0 D, with a maximum MRSE of +5.0 D, in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of < 0.5 D.

Brief profile

Carl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on TecDAX of the German stock exchange, is one of the world's leading medical technology suppliers. The company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. It provides complete packages of solutions for the diagnosis and treatment of eye diseases - including implants and consumable materials. The company creates innovative visualization solutions in the field of microsurgery. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiation therapy. In the 2009/2010 (30 September) financial year, around 2,200 employees generated revenue of EUR 676 million.

The head office of Carl Zeiss Meditec is in Jena, Germany. The company has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. Thirty-five percent of Carl Zeiss Meditec shares are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and opto-electronics industry. Carl Zeiss offers innovative solutions for the future-oriented markets Medical and Research Solutions, Industrial Solutions, Eye Care and Lifestyle Products. In financial year 2009/2010, the Group generated revenue of around EUR 2.98 billion. From financial year 2010/2011 onwards, eyeglass lens manufacturer Carl Zeiss Vision shall be integrated as an autonomous business group (revenue of around EUR 880 million in financial year 2009/2010). The Carl Zeiss Group thus employs a workforce of around 24,000 worldwide, more than 10,000 of whom are based in Germany. Carl Zeiss AG, Oberkochen, is wholly owned by the Carl Zeiss Foundation.

For further information see: http://www.meditec.zeiss.com

Contact:

Eva Sesselmann Director Group Communications Carl Zeiss Meditec AG Goeschwitzer StraBe 51-52 07745 Jena Telefon: +49 3641 220-331 Telefax: +49 3641 220-332 E-Mail: press@meditec.zeiss.com

Jackie Ferreira Sr. Director, Marketing Communications Carl Zeiss Meditec, Inc. 5160 Hacienda Dr. Dublin, CA 94568 Phone : +1 925 557 4488 Fax: +1 925 557 4615 E-Mail: j.ferreira@meditec.zeiss.com

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